Mirth MUx Selected By HealthBridge For Next Generation Healthcare Infrastructure.

Irvine, CA and Cincinnati, OH, November 10, 2009 – Mirth Corporation, the leader in commercial open source healthcare information technology, and HealthBridge, one of the nation’s largest and most advanced community health information exchanges today announced the selection of the Mirth Meaningful Use Exchange (Mirth MUx) as the core of HealthBridge’s next generation interoperability infrastructure. By implementing Mirth MUx HealthBridge becomes one of the nation’s first health information exchanges to enable physician access to critical patient information via the Nationwide Health Information Network (NHIN). The NHIN has been developed under the guidance of the Office of the National Coordinator for Health Information Technology (ONC) to serve as a nationwide, interoperable health information infrastructure. Mirth MUx helps organizations fast-track NHIN connectivity.
Built on the foundation of Mirth’s widely used open source healthcare interface engine, Mirth MUx speeds NHIN connectivity by fully incorporating the open source CONNECT software developed by the Federal Health Architecture program under ONC. CONNECT incorporates all of the standards and requirements outlined for the NHIN, helping organizations more quickly get connected into NHIN-enabled health information exchanges.
“For the past year Mirth has been a key technology partner to HealthBridge in enabling us to make critical patient information available to physicians where and when they need it across our community,” said Robert Steffel, chief executive officer for HealthBridge. “Now, with the addition of the NHIN-enabled Mirth MUx, as a central component of our infrastructure, we can extend our reach to enable information exchange with participating organizations nationally,” added Steffel.
HealthBridge provides connectivity for 28 hospitals, more than 5200 physician users, 700 physician practices, and 17 local health departments, as well as nursing homes, independent labs, radiology centers and others across the Greater Cincinnati healthcare community. It delivers nearly 3 million clinical messages and results to more than 5,200 physicians monthly.
Mirth MUx can help healthcare delivery organizations of all sizes achieve proposed meaningful use criteria for clinical information exchange. Physicians meeting these criteria have the potential to earn up to $44,000 over five years, and hospitals stand to earn millions in federal incentive dollars over a similar period for implementation and use of electronic health record systems. The ability to exchange clinical information is among the central components of these meaningful use criteria.
“HealthBridge has been widely recognized for their leadership in advancing health information exchange across communities and, more importantly, they have demonstrated a model for success both operationally and financially,” observed Jon Teichrow, president of Mirth Corporation. “Mirth Corporation is honored to be working with such a high caliber organization and delighted to play a part in the important work they do to create a safer more coordinated system of care delivery – one that works better for physicians and patients,” added Teichrow.
Mirth MUx enables healthcare organizations to securely exchange clinical information such as patient clinical summaries, lab results, medication histories and other records directly or via the NHIN. Designed to support standards such as HL7 and the Continuity of Care Document (CCD), Mirth MUx enables organizations to go live in weeks, and at a far lower cost than traditional vendor solutions. The Mirth MUx document portal gives authorized healthcare providers secure access to critical patient information via any Internet-connected computer.
Mirth MUx deployments are available on the Mirth E1000 Enterprise Appliance and the Mirth V1000 Virtual Appliance platforms. These enterprise-grade appliance platforms help reduce the time, effort and risk associated with implementation, and offer faster performance for organizations with high transaction volumes. Mirth MUx is also available as a hosted solution.
Since its launch as the Mirth Project in 2006, Mirth Connect – a core component of Mirth MUx – has become the most widely downloaded open source software for healthcare data integration, with over 70,000 worldwide downloads and a user community numbering over 7,000 professionals. Mirth Connect supports all major healthcare data interchange standards, including HL7, X12, DICOM, NCPDP, and XML.
Mirth

Philadelphia Jury Find GlaxoSmithKline Guilty In Paxil-Birth Defects Lawsuit

Philadelphia jury has found GlaxoSmithKline guilty of negligence, but not guilty of outrageous conduct. It Awarded 2.5 million. The verdict is the first of about 600 similar Paxil lawsuits filed across the United States according to the Associated Press
Drug maker GlaxoSmithKline plans to appeal a $2.5 million verdict in a lawsuit that alleged the company's antidepressant drug Paxil caused birth defects.
This lawsuit was launched by a Philadelphia family whose son was born four years ago with a number of heart defects.
In 2005, the U.S. Food and Drug Administration (FDA) issued warnings that Paxil may be associated with birth defects, the AP reported.

The first study illustrates the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. The authors followed pregnant women who in the past had major depression. During their pregnancy, some of these women were not feeling depressed and stopped taking their antidepressant medicines. Others stayed on their antidepressant medicines while pregnant. The women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were the women who continued to take their antidepressant medicine while pregnant. This study, by Lee Cohen and other authors, was published February 1, 2006 in the Journal of the American Medical Association (JAMA).

A second study suggests there may be additional, though rare, risks of SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk in one drug compared to another, and this risk has not so far been investigated by other researchers. The study, by Christina Chambers and others, was published on February 9, 2006 in The New England Journal of Medicine.

HealthCare At It's Best "CT Scan "Reset Error" Gives 206 Patients Radiation Overdose"

And they worry about malpractice? Via Slasdot

"As the LA Times reports, 206 patients receiving CT scans at Cedar Sinai hospital received up to eight times the X-ray exposure doctors intended. (The FDA alert gives details about the doses involved.)

Google Org Maps Flu Trends Over 16 Countries.

Google Org has expanded it's flu trends coverage to include 16 countries including most of the Europe. I see the patern of wintering countries of this year but the odd man out is Australia and New Zealand.
While Australia has minimal flu, there is flu activity in New Zealand. But according to Google, both the countries have continued to see a good correspondence between our estimates and official flu activity data. In fact, our analysis of last season shows that Google Flu Trends had a close 0.92 correlation with official U.S. flu data.
May be it is time you got that flu shot! Without being a number in Google Trends!
Official Google Blog: Google Flu Trends expands to 16 additional countries

Google Health Marches Along

Google Health is marching forward slowly but surely and have posted an update, Fall Update on Google Health.
We have kept close watch on the Google Health initiative and our selves have embarked on a quest to liberated certain health related data.
PHR, Personal Health Records were kept in hospital dungeons and were very hard to be shared with anyone but the the original creating hispital staff. Even they had to rumage through record rooms, we know because one of our dear friends made his fortune by designing a system to manage paper health records.
But thanks to initiatives like Google heatlth, the PHRs are becoming readily available any where in the world, as long as they have a connection to the net. Even in the case there is no internet connections, patients are more empowered to carry their own health information with them, say in a USB drive.
But there is more to the Google Health initiative and you might head over to Google Health Blog, to read the detail.

Official Google Blog: Fall update on Google Health

Fight The Flu Wash Your Hands

--------------------------------------------------
Cal Messages to keep the campus updated on H1N1 influenza will be sent to faculty, staff, and other campus groups as circumstances warrant during the flu season. Current information is available online on the UC Berkeley NewsCenter's flu-resource page. From there, click on "Flu resources and FAQ (UHS)" to get to the University Health Services page with information and links to additional resources, such as the Centers for Disease Control and the World Health Organization.

Health*Matters, the campus Wellness Program for Faculty and Staff, is offering interactive flu-prevention education in campus departments and work groups; materials can be customized to fit department needs. The workshop covers an interactive hand-washing exercise, coughing etiquette, and tips on staying healthy.

To schedule a customized session, contact Kristl Buluran at 643-9082 or visit Health*Matters H1N1 Prevention Workshops.

UC Berkeley Prepares For H1N1 influenza (Swine Flu)

UC Berkeley
BERKELEY — A campus team led by University Health Services (UHS) is preparing for the arrival at Berkeley of an unwanted visitor: H1N1 influenza. First called swine flu, H1N1 flu has already gotten a toehold in Northern California and is expected to hit schools and colleges this fall. Because of the possibility that large numbers within the campus community could be affected, officials here have been planning actively for the fall semester since the initial H1N1 outbreak in April.
The flu, whose spread the Centers for Disease Control and Prevention (CDC) is calling a pandemic, travels from human to human. Fortunately, at this point the severity of illness caused by the H1N1 virus is mild in most people.
To protect the health of students, faculty, and staff, UHS has teamed up with contagious-disease and flu experts from the School of Public Health, the city of Berkeley's public-health office, and campus representatives from housing and dining, academic services, recreational sports, and human resources.
"Active and concerted prevention efforts are going to be key to limiting the impact of this illness on our students and on campus operations as a whole," says Brad Buchman, medical director of University Health Services. "We have pulled together key campus departments and incorporated guidance from the UCOP Pandemic Advisory Board to help us prepare for what could potentially be a significant burden of illness on campus in the upcoming months."

An ounce of prevention

Preventive measures will help ward off the H1N1 flu. Two simple actions (both recommended by UHS) are washing your hands frequently and coughing into your sleeve. The campus is focusing prevention efforts at locations where the H1N1 flu could spread rapidly, including residence halls, dining halls, and the Recreational Sports Facility.
Signs that you're coming down with the flu include a sudden spike in temperature and a cough, says Buchman, while noting that it's not easy to differentiate between seasonal and H1N1 varieties based on symptoms. In either case, he says, the CDC recommends "self-isolation" — staying home — until 24 hours after your temperature has returned to normal.
\In addition to its annual seasonal-flu clinic, this year the Tang Center will provide H1N1 vaccinations — though the targeted vaccine won't arrive until late October. (Seasonal-flu-vaccine clinics will start as soon as that vaccine is received in the latter half of September.) UHS has forwarded its H1N1-vaccine request to the California Department of Public Health, based on estimates of campus population groups at highest risk, which include students, faculty, and staff with underlying medical conditions; the large percentage of students and staff between the ages of 18 and 24 years old; and health workers and emergency-preparedness personnel.
In addition to campus-wide prevention efforts and vaccination, UHS and other departments are planning for the possibility that the illness could become significantly widespread at Berkeley, and for the more remote possibility that the illness caused by the H1N1 virus could become more severe.

PLoS Currents: Influenza, Infobase for luenza Research

Public Library of Science (PLoS) has launched "PLoS Currents"(Beta), A innovative and experimental website to share the research results and ideas rapidly.
Keeping up with current issues and responding to the recent worldwide H1N1 influenza outbreak, the first PLoS Currents research theme is influenza.
The site uses many tools like Google Knol and NCBI (National Center for Biotechnology Information) database called Rapid Research Notes, Both which are created and moderated by the experts in the field.
The value of this type of information sources is that they are available to anyone from anywhere with internet connection.
PLoS Currents: Influenza welcomes contributions covering any and all aspects of research into influenza: influenza virology, genetics, immunity, structural biology, genomics, epidemiology, modeling, evolution, policy and control. Contributions might take the form of new datasets, preliminary analyses or entire manuscripts. The launch site already features new findings from some outstanding influenza researchers.

To enable contributions to PLoS Currents: Influenza to be shared as rapidly as possible, they will not be subject to in-depth peer review; however, unsuitable submissions will be screened out by a board of expert moderators led by Eddie Holmes (Center for Infectious Disease Dynamics, Pennsylvania State University) and Peter Palese (Department of Microbiology, Mount Sinai School of Medicine).
Official Google Blog: A new website for the rapid sharing of influenza research

Tags: PLoS Currents, Influenza, H1N1 Influenza, NCBI, Public Library of Science, google knol

Truth About Health Care CEO, Rick Scott, Who's Funding Anti-Reform Effort, Revealed By CNN Anchor Sanchez.

First of all Thanks goes to Anchor Sanchez for having a backbone and CNN for allowing him to have one.
CNN's Sanchez today smacked Rick Scott, the founder of an organization, Conservatives for Patients' Rights, that's been funding anti-health care reform protests. People this do gooder is the former CEO of a hospital company that paid $1.7 billion to settle charges of overcharging Medicare and Medicaid.
Read more about it at TPM after the video; Turn your volume up and listen and you may learn why the healthcare is in such a bad state.

TPM

Tags: CNN's Sanchez, Rick Scott, Conservatives for Patients' Rights, health care reform

Guidance on Preventing Melamine Contamination For Pharmaceutical Industry

FDA Issues Pharmaceutical Industry Guidance on Preventing Melamine Contamination

In a guidance issued today, the U.S. Food and Drug Administration says that certain pharmaceutical ingredients used in the manufacture or preparation of drug products should be tested for melamine.

Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides. If ingested in sufficient amounts, melamine can result in kidney failure and death.

Although the FDA has no reason to believe that the U.S. pharmaceutical supply is contaminated with melamine, recent events involving pet and livestock food products in the United States, and milk products for infants in China, underscore the potential problem.

The guidance is an initial measure by the agency in working with pharmaceutical manufacturers, repackers, other suppliers and pharmacists to conduct melamine testing. The agency invites comments on the guidance, available online and titled "Guidance for Industry: Pharmaceutical Components At Risk for Melamine Contamination".

“The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry on this serious public health concern.”

The FDA identifies specific pharmaceutical ingredients in the guidance that are recommended to be screened for the presence of melamine. The guidance also recommends the use of FDA-published methods for this testing that are used to detect the presence of melamine in food proteins. These tests rely on equipment that is generally available to pharmaceutical manufacturers or contract testing labs. The agency also is developing a sampling and testing program for pharmaceutical ingredients at risk for melamine contamination.

Comments may be submitted electronically at http://www.regulations.gov or by mail to FDA, Division of Dockets Management (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with docket number FDA-2009-D-0354.

Tags: Pharmaceutical Industry, FDA, Melamine Contamination

Ground Beef Recall : Beef Packers, Inc., a Fresno, California, Recalls 825,769 pounds of ground beef due to salmonellosis Outbreak

Class I Recall
Beef Packers, Inc., a Fresno, Calif., establishment, is recalling approximately 825,769 pounds of ground beef products that may be linked to an outbreak of salmonellosis, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.
Recallr: Beef Packers, Inc., a Fresno, California, Recalls 825,769 pounds of ground beef due to salmonellosis Outbreak
Tags: Beef Recall, USDA Alert, salmonellosis, FSIS Recall, Beef Packers Recall, Salmonella

FDA Rejects KRYSTEXXA As A Treatment For Chronic Gout

Savient Pharmaceuticals (SVNT) announced that it has received a complete response letter from the U.S. Food and Drug Administration stating that the FDA cannot at this time approve the Company's application for KRYSTEXXA as a treatment for chronic gout in patients refractory to conventional therapy.
Market News Video

Tags: Approval, Chronic Gout, Savient Pharmaceuticals, KRYSTEXXA

Conn. Sen. Dodd will spend the month of August pushing for health care reform

Sen. Chris Dodd will spend the month of August working for national health care reform. He will also be dealing with his own health care, stemming from detection of cancer. Goog Luck with both, Senetor. We need both.

Tags: national health care reform, Sen. Chris Dodd

Malaria, Chimps Gift To Mankind.

UCI’s Francisco Ayala

Deadly parasite jumped to humans from chimpanzees, perhaps through one mosquito

— Irvine, Calif., August 3, 2009 —

Researchers have identified what they believe is the original source of malignant malaria: a parasite found in chimpanzees in equatorial Africa.

UC Irvine biologist Francisco Ayala and colleagues think the deadly parasite was transmitted to humans from chimpanzees perhaps as recently as 5,000 years ago - and possibly through a single mosquito, genetic analyses indicate. Previously, malaria's origin had been unclear.

This discovery could aid the development of a vaccine for malaria, which sickens about 500 million people and kills about 1.5 million each year. It also furthers understanding of how infectious diseases such as HIV, SARS, and avian and swine flu can be transmitted to humans from animals.

"When malaria transferred to humans, it became very severe very quickly," said Ayala, co-author of the study that reports these findings. "The disease in humans has become resistant to many drugs. It's my hope that our discovery will bring us closer to making a vaccine."

The study appears online the week of Aug. 3 in the Proceedings of the National Academy of Sciences.

Human malignant malaria is caused by a parasite called Plasmodium falciparum, which is responsible for 85 percent of all infections and nearly all malaria deaths. Chimpanzees were known to carry a closely related parasite called Plasmodium reichenowi, but most scientists assumed the two had existed separately in humans and chimpanzees for the last 5 million years.

Scientists in the current study examined several new strains of the parasite found in blood taken from wild and wild-born chimpanzees in Cameroon and Ivory Coast sanctuaries during routine health exams.

A gene analysis linked one chimpanzee strain to all worldwide strains of the human malaria parasite. This connection suggests that one mosquito may have transferred malaria to humans. Because there is little genetic variance among strains of the human parasite, scientists believe the transmission occurred in the recent past - maybe 5,000 to 2 million years ago - though an exact time could not be determined.

The results support an earlier hypothesis by Dr. Ajit Varki of UC San Diego and colleagues that genetic mutations made humans first resistant to sickness from the chimpanzee parasite, then extremely susceptible to illness from the human form.

They also corroborate an earlier finding by Ayala and former UCI graduate student Stephen Rich that malignant malaria started spreading throughout the tropics and world about 5,000 years ago, when agriculture began in Africa. Rich, now a professor at the University of Massachusetts Amherst, is the lead author of the current PNAS study.

In addition to Ayala and Rich, Nathan Wolfe of Stanford University worked on the study, along with collaborators from the Robert Koch Institute and the Max Planck Institute for Evolutionary Anthropology in Germany; the Global Viral Forecasting Initiative in San Francisco; the Biotechnology Centre in Cameroon; the U.S. Department of Agriculture; and the Ebola Tai Forest Project in the Ivory Coast.

The study was funded by the National Institutes of Health, with additional support from the Cummings School of Veterinary Medicine at Tufts University and the National Geographic Society Committee for Research & Exploration.

About the University of California, Irvine: Founded in 1965, UCI is a top-ranked university dedicated to research, scholarship and community service. Led by Chancellor Michael Drake since 2005, UCI is among the fastest-growing University of California campuses, with more than 27,000 undergraduate and graduate students, 1,100 faculty and 9,200 staff. The top employer in dynamic Orange County, UCI contributes an annual economic impact of $4.2 billion. For more UCI news, visit http://today.uci.edu/.

Tags: University of California, Plasmodium reichenowi, Plasmodium falciparum, malaria origin, malignant malaria, HIV, SARS, avian flu, Swine Flu

FDA Issues Draft Guidelines To Eliminate Microbial Contamination In Tomatoes, Leafy Greens, And Melons.

The U.S. Food and Drug Administration has published three draft guidances designed to help growers and others across the entire supply chain minimize or eliminate microbial contamination in tomatoes, leafy greens, and melons.

The guidances are, in part, based on those originally developed by the produce industry with assistance from FDA. They represent the first step in a fundamental shift in strategy for the agency in the prevention of foodborne hazards associated with fresh fruits and vegetables.

“These guidances embody the Obama Administration’s and FDA’s prevention-oriented food safety strategy,” said FDA Commissioner Margaret A. Hamburg, M.D. “They will be made final as soon as possible after public comment, and will be followed within two years by enforceable standards for fresh produce.”

These commodity-specific guidances were called for by the President’s Food Safety Working Group, which recommends a new, public-health focused approach to food safety. In a report issued earlier this month, the working group made recommendations aimed at creating a stronger food safety system. The recommendations stem from three core food safety principles:

• Prevent harm to consumers
• Use good data and analysis to ensure effective food safety inspections and enforcement of the law
• Identify outbreaks of foodborne illness quickly and stop them

Key elements of the draft guidances related to the working group’s strategies include:

• An acceptable baseline standard of industry practices that help both domestic and foreign firms minimize the risk for microbial contamination of their products throughout the entire supply chain
• Recommendations regarding growing, harvesting, packing, processing, transportation, and distribution of the product
• Recommendations for recordkeeping, including some that will help the FDA determine more quickly the source of outbreaks that do occur.

Comments on FDA’s guidance documents may be submitted at any time. However, to ensure that comments are received in time for consideration in drafting final versions of these guidance documents, written or electronic comments should be submitted within 90 days of publication in the Federal Register. See http://www.regulations.gov for information.

• News Release: HHS Secretary Sebelius, Agriculture Secretary Vilsack Announce New Strategies to Keep America's Food Supply Safe
• Questions and Answers on FDA’s Proposed Commodity-Specific Guidances (CSGs)
• The Draft Guidances
  • Guide to Minimize Microbial Food Safety Hazards of Tomatoes
  • Guide to Minimize Microbial Food Safety Hazards of Melons
  • Guide to Minimize Microbial Food Safety Hazards of Leafy Greens

Tags: Microbial Contamination, FDA Guidance, foodborne hazards

Onglyza (saxagliptin), New Drug To Treat Type 2 Diabetes, Approved By FDA

For Immediate Release: July 31, 2009

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Drug Treatment for Type 2 Diabetes

The U.S. Food and Drug Administration today approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have diabetes. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

Tags: Onglyza, saxagliptin, Type 2 Diabetes, FDA Approval, dipeptidyl peptidase-4, Bristol-Myers Squibb

Abbott Vascular Recalls POWERSAIL® Coronary Dilatation Catheters.

Abbott Vascular has recalled three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage.
Recallr: Abbott Recalls POWERSAIL® Coronary Dilatation Catheters
Tags: POWERSAIL® Coronary Dilatation Catheters recall, Abbott Vascular recall, FDA Recall, powersail recall, Coronary Dilatation Catheter recall

Guidance for Industry, Drug-Induced Liver Injury

FDA has released a guidance to assist the pharmaceutical industry and other investigators who are conducting new drug development in assessing the potential for a drug or a product to cause severe liver injury (i.e., irreversible liver failure that is fatal or requires liver transplantation).

In particular, the guidance addresses how laboratory measurements that signal the potential for such drug-induced liver injury (DILI) can be obtained and evaluated during drug development.

This evaluation is important because most drugs that cause severe DILI do so infrequently; typical drug development databases with up to a few thousand subjects exposed to a new drug will not show any cases. Databases may, however, show evidence or signals of a drug’s potential for severe DILI if the clinical and laboratory data are properly evaluated for evidence of lesser injury that may not be severe, but may predict the ability to cause more severe injuries. This guidance describes an approach that can be used to distinguish signals of DILI that identify drugs likely to cause severe liver injury from signals that do not suggest such a potential. This guidance does not address issues of preclinical evaluation for signals of DILI, nor the detection and assessment of DILI after drug approval and marketing.
The guidance is available from FDA.
Follow the link below for a PDF file;
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf

Tags: drug-induced liver injury, DILI, drug development databases, FDA Guidance, pharmaceutical industry

New Abd Genetic Drug Approvals By FDA (July 28th 2009)

After being absent for a while, new and generic drug approvals by FDA will be listed again.

Following Drugs were Approved by FDA on July 28, 2009

• • Actonel (risedronate sodium) Tablets, P & G Pharmaceuticals, Inc., Efficacy Supp. w/Clinical Data
  • Amlodipine Besylate and Benazepril Hydrochloride Capsules, Mylan Pharmaceuticals Inc., Tentative Approval
  • Cellcept (mycophenolate mofetil) Tablets, Roche Palo Alto, LLC, Manufacturing Change or Addition
  • Lamivudine and Zidovudine Tablets, Aurobindo Pharma Limited, Tentative Approval
  • Penicillin G Potassium Injection, G.C. Hanford Manufacturing Company, Approval
  • Solodyn (minocycline HCl) Extended Release Tablets, Medicis Pharmaceutical Corporation, Control Supplement
  • Zidovudine Tablets, Aurobindo Pharma Limited, Approval
    

Tags: Actonel, Zidovudine, Solodyn, Penicillin G Potassium, Lamivudine, ZidovudineCellcept, Amlodipine Besylate, Benazepril Hydrochloride

Electronic Cigarettes (e-Cigarettes) Could Increase Nicotine Addiction, FDA Warns

Image From Wikipedia

If you are a smoker, please just stop! You can get help at Smokefree.Gov

FDA and Public Health Experts Warn About Electronic Cigarettes

The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

Electronic cigarettes, also called “e-cigarettes,” are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

These products are marketed and sold to young people and are readily available online and in shopping malls. In addition, these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people.

Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people. Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium and Jonathan Samet, M.D., director of the Institute for Global Health at the University of Southern California, joined Joshua Sharfstein, M.D., principal deputy commissioner of the FDA, and Matthew McKenna, M.D., director of the Office of Smoking and Health for the Centers for Disease Control and Prevention, to discuss the potential risks associated with the use of electronic cigarettes.

“The FDA is concerned about the safety of these products and how they are marketed to the public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user.

The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.

The FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of e-cigarettes to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

• Online: http://www.fda.gov/Safety/MedWatch/default.htm
• Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088

#

For More Information
Electronic Cigarettes

Tags: carcinogenic to humans, Electronic Cigarettes, e-Cigarettes, Smokefree.Gov, FDA Advisory

National Institutes of Health Stops Viagra Trial

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped a clinical trial testing a drug treatment for pulmonary hypertension in adults with sickle cell disease nearly one year early due to safety concerns. In an interim review of safety data from 33 participants who completed 16 weeks of treatment, researchers found that, compared to participants on placebo (dummy pill), participants taking sildenafil (Revatio) were significantly more likely to have serious medical problems. The most common problem was episodes of severe pain called sickle cell crises, which resulted in hospitalization. No deaths have been associated with the drug in the clinical trial.

Known as walk-PHaSST, the study was the first multicenter, randomized clinical trial to test the safety and effectiveness of sildenafil for pulmonary hypertension in patients with sickle cell disease, one of the most common genetic blood disorders in the United States. Pulmonary hypertension is a debilitating condition of high blood pressure in the arteries that carry blood to the lungs, which can lead to heart failure and death. Approximately 30 percent of sickle cell disease patients develop pulmonary hypertension, and even mild levels of pulmonary hypertension have been associated with sudden death in people with sickle cell disease.

"The increase in sickle cell medical problems is concern enough for us to stop this clinical trial to protect the safety of our participants," said NHLBI Director Elizabeth G. Nabel, M.D. "We will continue to look into the possible causes of these preliminary results. In the meantime, we encourage patients with sickle cell disease who are taking sildenafil for pulmonary hypertension to talk with their physicians about the potential risks and benefits of the medication and what actions they should consider, including whether to taper off this medication and how to best manage both sickle cell disease and pulmonary hypertension."

Because the medical problems experienced in walk-PHaSST were complications specific to sickle cell disease, "The findings of the walk-PHaSST study should not be applied to other groups of patients with pulmonary hypertension where the drug has been found to be safe and effective," Nabel added.

Researchers are conducting extensive analyses of the study results, which could contribute to recommendations for treating pulmonary hypertension in patients with sickle cell disease. They will prepare reports of their research for publication in peer-reviewed journals.

Walk PHaSST was conducted at the following locations:

• Children's Hospital, Oakland, Calif.
• University of Colorado, Denver
• Howard University Hospital, Washington, D.C.
• University of Illinois at Chicago
• Johns Hopkins Medical Institutions, Baltimore
• NIH Clinical Center, Bethesda, Md.
• Albert Einstein College of Medicine, New York City
• Columbia University, New York City
• Children's Hospital, Pittsburgh
• Imperial College London and Hammersmith Hospital, London, England

Rho Inc. of Chapel Hill, N.C., serves as the data coordinating center. Pfizer provided the treatment drug and placebo for the study.

NHI

Tags: NHLBI, NIH, walk-PHaSST, sildenafil, pulmonary hypertension

FDA Warns Against Body-building Supplements Claiming To Be Steroids

The FDA is notifying the public about new safety information concerning products marketed for body building and increasing muscle mass. The FDA has sent a Warning Letter to a manufacturer of body building supplements that claim to contain steroid-like ingredients, but in fact contain synthetic steroids. The products named in the Warning Letter are marketed by American Cellular Laboratories, Inc., and include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme.”

The FDA has received reports of serious adverse events associated with the use of these products and other similar products. Products like these are frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength and are sold both online and in retail stores. They are often promoted to athletes to improve sports performance and to aid in recovery from training and sporting events. Although products containing synthetic steroids are frequently marketed as dietary supplements, they are NOT dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.

Adverse event reports received by the FDA for body building products that are labeled to contain steroids or steroid alternatives involve men (ages 22-55) and include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung).

Due to the potentially serious health risks associated with using these types of products, the FDA recommends that consumers immediately stop using all body building products that claim to contain steroids or steroid-like substances. Consumers should consult their health care professional if they are experiencing symptoms possibly associated with these products, particularly nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes) or brown/discolored urine. The FDA also recommends that consumers talk with their health care professional about any body building supplements they are taking or planning to take, particularly if they are uncertain about a product’s ingredients.

Health care professionals are advised to ask their patients about any over-the-counter products they may be using, including products marketed as dietary supplements. Additionally, health care professionals should be alert to patients presenting with the warning signs that may be associated with the use of steroids or steroid-like substances, including liver injury, kidney failure, stroke, and hormone-associated adverse effects, such as blood clots, including pulmonary embolism and deep vein thrombosis.

Health care professionals and consumers are encouraged to report any adverse events related to the use of these products to FDA's MedWatch Adverse Event Reporting program, either online, by regular mail or by fax, using the contact information at the bottom of this page.

For more details about these products see FDA’s Consumer Information piece (Consumer Update)Warning on Body Building Products Marketed as Containing Steroids or Steroid-Like Substances.

Tags: TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, fda warning

Tanning Beds, As Dangerous As Arsanic And Cigarettes.

An IARC Working Group has classified UV-emitting tanning devices as “carcinogenic to humans” (Group 1). The Working Group was convened by the IARC Monographs programme and the conclusions are reported in an article and press release issued today by The Lancet Oncology .

Combined analysis of over 20 epidemiological studies shows that the risk of cutaneous melanoma is increased by 75% when the use of tanning devices starts before age 30. There is also sufficient evidence of an increased risk of ocular melanoma associated with the use of tanning devices. Studies in experimental animals support these conclusions and demonstrate that ultraviolet radiation (UVA, UVB, and UVC) is carcinogenic to humans.

These findings reinforce current recommendations by the World Health Organization to avoid sunlamps and tanning parlours and to protect yourself from overexposure to the sun.

Further information can be found in the 2006 report of an earlier IARC Working Group and from WHO's website at http://www.who.int/mediacentre/factsheets/fs287/en/.

Tags: IARC, carcinogenic to humans, UVA, UVB, UVC, World Health Organization, tanning danger

HealthCare Insurance Reform, What You Stand To Gain!

• No Discrimination for Pre-Existing Conditions
• Insurance companies will be prohibited from refusing you coverage because of your medical history.
• No Exorbitant Out-of-Pocket Expenses, Deductibles or Co-Pays
• Insurance companies will have to abide by yearly caps on how much they can charge for out-of-pocket expenses.
• No Cost-Sharing for Preventive Care
• Insurance companies must fully cover, without charge, regular checkups and tests that help you prevent illness, such as mammograms or eye and foot exams for diabetics.
• No Dropping of Coverage for Seriously Ill
• Insurance companies will be prohibited from dropping or watering down insurance coverage for those who become seriously ill.
• No Gender Discrimination
• Insurance companies will be prohibited from charging you more because of your gender.
• No Annual or Lifetime Caps on Coverage
• Insurance companies will be prevented from placing annual or lifetime caps on the coverage you receive.
• Extended Coverage for Young Adults
• Children would continue to be eligible for family coverage through the age of 26.
• Guaranteed Insurance Renewal
• Insurance companies will be required to renew any policy as long as the policyholder pays their premium in full. Insurance companies won't be allowed to refuse renewal because someone became sick.

Thank you President Obama!

Tags: Health Insurance, healthcare reform, Barak Obama

Summer, Barbecuing, And Food Safety

We all love to have a barbecue in this nice and warm sunny days of summer. What a better way to enjoy a day with friends and family. Usually these are the occasions that brings families together and rekindle family ties and friendships.
So you certainly do not want to get sick or make anyone sick during these happy occasions and I found this great and siple guide lines to having a super and safe barbecues and family outings at health Canada site. (link at the end of the article). Have a great summer and many a barbecues!

At the store

When you're at the grocery store, buy cold food at the end of your shopping. Make sure to keep raw meat separate from other products. You can put packages of raw meat in separate plastic bags to keep meat juices from leaking onto other foods. This helps avoid possible cross-contamination and prevents the spread of foodborne illness. Always refrigerate perishable foods within one to two hours, especially in warm weather.

Storing raw meat

In the refrigerator

At home, store raw meat in the refrigerator immediately after you return from the grocery store. Freeze raw poultry or ground beef that won't be used within one to two days. Freeze other meats within four to five days.

Marinate meat in the refrigerator, not on the counter. Remember to set some marinade aside in the fridge if you want to use it later to baste meat or use it as a dipping sauce. Do not use leftover marinade from the raw food on the cooked food.

In the cooler

If you are storing your meat in a cooler before barbecuing, make sure that the cooler is kept cold with ice packs. Keep the cooler out of direct sunlight and avoid opening it too often, because it lets cold air out and warm air in. You may also want to use two coolers, one for drinks (as it may get opened more often) and another one for food.

Whether you are storing the meat in the refrigerator or a cooler, always remember to keep food out of the temperature danger zone of 4°C to 60°C (40°F to 140°F). Bacteria can grow in this temperature range. After only two hours in this range, your food can become dangerous.

Cross-contamination

To avoid potential cross-contamination and the spread of foodborne illness, follow the following steps:

• Make sure to keep raw meat away from other foods, including vegetables such as lettuce and tomatoes. You can do this by packing meats separately or by making sure they are wrapped separately, so that juices don't leak out onto other foods.
• Wash your hands carefully with soap and warm water for at least 15- 20 seconds before and after handling raw meat.
• Clean all your cooking equipment, utensils and work surfaces, and then sanitize them with a mild bleach solution, in the following manner:
  • Combine 5 mL (1 tsp) of bleach with 750 mL (3 cups) of water in a labelled spray bottle.
  • Spray the bleach solution on the surface/utensil and let stand briefly.
  • Rinse with lots of clean water and air dry (or use clean towels).

Thawing

Thawing should be done in the refrigerator. Sealed packages can be thawed in cold water. Microwave defrosting is acceptable if the food item is placed immediately on the grill. Meat should be completely thawed before grilling so that it cooks more evenly.

Cook thoroughly and use a digital food thermometer

Bacteria such as E. coli , Salmonella and Listeria can only be killed by heat. Raw meat must be cooked properly to a safe internal temperature (see chart below) to avoid foodborne illness. Colour alone is not a reliable indicator that meat is safe to eat. Meat can turn brown before all the bacteria are killed, so use a digital food thermometer to be sure.

To check the temperature of meat that you are cooking on the barbecue, take it off the grill and place it in a clean plate. Insert the digital food thermometer through the thickest part of the meat. For hamburgers, you should insert the digital food thermometer through the side of the patty, all the way to the middle. Make sure to check each piece of meat or patty because heat can be uneven.

Do not use the same plate or utensils for raw and cooked meat because cross-contamination can occur. Raw juices can spread bacteria to your safely-cooked food and cause foodborne illness.

Remember to always clean your digital food thermometer in warm, soapy water between temperature readings to avoid cross-contamination.

Internal Cooking Temperatures

You can't tell by looking. Use a digital food thermometer to be sure!

Food	Temperature
Beef, veal and lamb (pieces and whole cuts) Medium-rare Medium Well done	63°C (145°F) 71°C (160°F) 77°C (170°F)
Pork (pieces and whole cuts)	71°C (160°F)
Poultry (e.g. chicken, turkey, duck) Pieces Whole	74°C (165°F) 85°C (185°F)
Ground meat and meat mixtures (e.g. burgers, sausages, meatballs, meatloaf, casseroles) Beef, veal, lamb and pork Poultry	71°C (160°F) 74°C (165°F)
Egg dishes	74°C (165°F)
Others (e.g. hot dogs, stuffing, leftovers)	74°C (165°F)

Keep hot food hot

Remember to keep hot food hot until served. Keep cooked meats hot by setting them to the side of the grill, not directly over coals where they can overcook.

Serving food

Use a clean plate when taking food off the grill. Remember not to put cooked food on the same plate that held raw meat. This prevents it from being re-contaminated by raw juices.

Leftovers

Cool food by using shallow containers, so that it cools quickly. Discard any food left out for more than two hours. On hot summer days, don't keep food at room temperature for more than one hour. Remember to keep food out of the temperature danger zone of 4°C to 60°C (40°F to 140°F). When in doubt, throw it out!

For more information on food safety, please visit Health Canada's website,

Tags: Summer, Barbecuing, Food Safety, raw poultry, raw meat, Salmonella, Listeria, foodborne illness

Chantix (varenicline) and Zyban (buproprion) Label Change Required To Indicate Serious Mental Health Events.

FDA earlier in may 2008 approved a label change for smoking cessation aid, Chantix but now have released another request for label change. This time it has added Zyban to the list as well. The labeling approval came after an Advisory on Chantix by FDA, which was issued in February 2008.

Similar information on mental health events will be required for buproprion marketed as the antidepressant Wellbutrin and for generic versions of buproprion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

For Immediate Release: July 1, 2009

Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (buproprion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Similar information on mental health events will be required for buproprion marketed as the antidepressant Wellbutrin and for generic versions of buproprion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

Woodcock said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. She added that patients should immediately contact their health care professional if they experience such changes.

The FDA’s request for the additional warnings is based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.

The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.

Neither Chantix nor Zyban contain nicotine and some of these symptoms may be a response to nicotine withdrawal. People who stop smoking may experience symptoms such as depression, anxiety, irritability, restlessness, and sleep disturbances. However, some patients who were using these products experienced the reported adverse events while they were still smoking.
In addition to the Boxed Warning, the FDA also is requesting more information in the Warnings section of the prescribing information and updated information in the Medication Guide for patients that further discuss the risk of mental health events when using these products.

Manufacturers also will be required to conduct a clinical trial to determine how often serious neuropsychiatric symptoms occur in patients using various smoking cessation therapies, including patients who currently have psychiatric disorders. The FDA’s review of adverse events for patients using nicotine patches did not identify a clear link between those medications and suicidal events.

Chantix is manufactured by New York-based Pfizer Inc. Zyban is manufactured by GlaxoSmithKline, Brentford, Middlesex, United Kingdom.

Tags: Chantix, zyban, FDA, FDA Advisory, neuropsychiatric symptoms, quit smoking, buproprion, Wellbutrin, GlaxoSmithKline, Pfizer Inc

Public Input on Tobacco Regulation

As we have posted earlier, FDA would like to know your ideas on tobacco regulation. Your input will be great addition to and a help towards controlling tobacco industry and how it affects all of us in the future.
Please follow the links below and provide your input, whatever it might be!

FDA Seeks Public Input on Tobacco Regulation

The U.S. Food and Drug Administration announced today that it is seeking public input on the implementation of its historic new authority overseeing tobacco products in the United States. In a Federal Register notice, the agency invites the public to provide information and share views on a wide range of topics, from product content to advertising and marketing. All public comments will be posted online.

"We're interested in receiving input from across the country as the FDA begins to implement this important new authority intended to reduce the enormous toll of suffering and death caused by tobacco products in the United States," said Dr. Margaret A. Hamburg, Commissioner of Food and Drugs. "We look forward to the public's response."

The Federal Register notice can be viewed at: http://www.federalregister.gov/OFRUpload/OFRData/2009-15549_PI.pdf.

For more information about the FDA and tobacco regulation, see: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm168412.htm.

Tags: Tobacco Regulation, FDA, Stop Smoking, FDA, Family Smoking Prevention and Tobacco Control Act, US Government

Swine Flu (H1N1) Estimated To Have Jumped 1Million Mark

Map of the spread of Influenza A(H1N1): number of laboratory confirmed cases and deaths
Click on the image for a larger version

Even though the official lab reported by WHO figures remain less than 100,000, Centers for Decease Control (CDC) have issued estimations based on surveys which says the ballpark figure to be over 1 million people. It continues to rise as the number of infections seem to continue.

So far the flu has spread to many areas of the country, Dr. Schuchat noted, and the C.D.C. has heard of outbreaks in 34 summer camps in 16 states. In total about 3,000 Americans have been hospitalized, she said, and 127 have died.

According to Dr. Schuchat, five American vaccine companies are working on a swine flu vaccine. It is estimated that once the new vaccine is tested for both safety and effectiveness, there will be about 60 million doses will be available by September. Since there will be difficult choices to take determining whom to give the vaccines, it will be beneficial to keep your health in top form.

Tags: CDC, H1N1 Flu, Swine Flu, WHO, swine flu vaccine

Could PainKillers Lead To Cardiac Arrest?

As world is realing from the untimely and sudden death of Michael Jackson, who died Thursday 25 2009, at age 50. Authorities believe that Michael Jackson succumbed to a cardiac arrest at his home. Perhaps it is time you thought of your own life,

Tags: michael Jackson, Cardiac Arrest, Austin Health

Tobacco Regulation, FDA, Stop Smoking And You.

The Family Smoking Prevention and Tobacco Control Act (PDF, 350 K) was signed by President Barack Obama On June 22, 2009. The FDA, the U.S. Food and Drug Administration was granted authority to regulate tobacco products. I wish this had happened earlier. What ever the politicians and the tobacco lobbyists say, this can do only good to USA and it's people.

FDA has announced that it will perform its duties by using the best available science to guide the development and implementation of effective public health strategies to reduce the burden of illness and death caused by tobacco products.

But most important part of this historic legislation is that FDA is seeking input from the public as it begins working to implement the Act. Please Contact FDA and provide your ideas and concerns. I really hope they will help to eliminate these harmful products from this country. As the whole world look at USA as a leader in many fronts, I hope they too pick up on this development.

I was a once foolish smoker who realized the harm it does to me and I have successfully given up smoking and remained such for more than four years now. I am enjoying my life and simple things like constant flu and cold infections have gone. Last an previous winter, I did not catch a cold even once. This is one most cherished accomplishments of mine and I proudly promote the fact.

For information about approved products for tobacco cessation, visit Approved Products for Tobacco Cessation.

For information on community programs for effective tobacco control, visit CDC's State and Community Resources web site.
If you are an smoker, please consider giving up, for yourself, for your children and people around you. It is not difficult as many people think it is. Most needed element is your willingness to stop smoking and genuine need to fulfill your will.

Tags: Tobacco Regulation, FDA, Stop Smoking, FDA, Family Smoking Prevention and Tobacco Control Act, US Government

What Is Swine (H1N1) flu And What Are The Symptoms?

Dr. Joe Bresee, with CDC's Influenza Division, describes the symptoms of swine flu and warning signs to look for that indicate the need for urgent medical attention.

H1N1 or “swine flu” as it is commonly referred to as, is a new influenza virus causing illness in people. According to PandemicFlu.gov, this influenza virus was first detected in people in the United States in April 2009. Other countries, including Mexico, Japan and Canada, have reported people sick with this new virus.
The original reference of this flu as “swine flu” came to be because laboratory testing showed that many of the genes in this new virus were very similar to influenza viruses that normally occur in pigs in North America. Further studies have shown that H1N1 virus is very different from what normally circulates in North American pigs. It has two genes from flu viruses that normally circulate in pigs in Europe and Asia and avian genes and human genes. Scientists call this a “quadruple reassortant” virus.
CDC has determined that this virus is contagious and is spreading from human to human. However, at this time, it not known how easily the virus spreads between people.
You can keep yourself updated at Pandemicfly.org and be safe. H1N1 virus is fatal and extreme care should be taken.

Tags: H1N1, swine flu, PandemicFlu.gov, H1N1 influenza virus, CDC, symptoms of swine flu, symptoms of H1N1

F.D.A. Warns Against Use of Zicam Cold Remedy

FDA Advises Consumers Not To Use Certain Zicam Cold Remedies

Intranasal Zinc Product Linked to Loss of Sense of Smell

The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.

The products are:
--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”

People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.

“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of CDER’s Office of Compliance.

Health care professionals and consumers are encouraged to report adverse events (side effects) that may be related to the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
--Online
--Regular Mail: use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: 800-FDA-0178
--Phone: 800-FDA-1088

For more information:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm166834.htm

Tags: Zicam Cold Remedy, FDA, Anosmia, loss of sense of smell

Medtronic Kappa and Sigma pacemakers Recall ()

Recallr: Medtronic Pacemaker Recall (Kappa and Sigma pacemakers)

Leukotriene Modifiers Labeling Change Requested By FDA.

For Immediate Release: June 12, 2009

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Requests Labeling Change for Leukotriene Modifiers

The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. The FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).

Leukotrienes are chemicals the body releases in response to an inflammatory stimulus, such as when a person breathes in an allergen. Montelukast and zafirlukast are leukotriene receptor antagonists that work by blocking leukotrienes. Zileuton is a leukotriene synthesis inhibitor which works by stopping the formation of certain substances that cause swelling, tightening, and mucus production in the airways.

For more information:
Previous and latest update

California Man sentenced for illegally distributing Serostim, an HIV drug.

CONCORD, NEW HAMPSHIRE: Thomas Lavery, of Irvine, CA, was sentenced to 52 months of incarceration to be followed by three years of supervised release for illegally distributing large quantities of Serostim, an HIV drug, which were illegally purchased from illegitimate sources and then illegally sold to wholesale distributors in various parts of the country, using falsified paperwork. Judge McAuliffe also entered an order of forfeiture against Lavery for the sum of $1,009,460.

Previously, on September 4, 2007, Lavery pleaded guilty to a forty-four count Indictment charging him with wire fraud conspiracy and wire fraud, money laundering, and conspiracy to engage in unlicensed wholesale distribution of prescription drugs, and false statements in a matter under the jurisdiction of the U.S. Food and Drug Administration.

The scheme, in which Lavery was found by Judge McAuliffe to be a leader and organizer, involved purchasing large quantities of Serostim from illegitimate sources in Palm Springs and Los Angeles, California at prices significantly below the price that the manufacturer charges pharmacies. Specifically, the Serostim was purchased from HIV infected patients and then reintroduced into the wholesale distribution chain by using false documentation to make it appear that the Serostim had come from legitimate licensed wholesalers when in fact it had been previously dispensed to HIV infected patients.

In furtherance of the scheme, Lavery purchased the Serostim from suppliers who had in turn purchased the Serostim directly from the HIV infected patients. Lavery worked with Beth Handy of Milford, NH who has also pleaded guilty to similar charges in U.S. District Court in Concord and is now awaiting sentencing. During the time frame of the scheme, Handy was licensed by the New Hampshire Board of Pharmacy as a wholesaler of prescription drugs doing business in the State of New Hampshire. Handy solicited licensed wholesalers of prescription.

Read the complete report at the U.S. Attorney's Web site.

Be Safe, Wash Your Hands, Avoid Swine Influenza And Other Virus Infections.

WHO has published the following poster instructing the correct procedure to wash hands and be safe. Click on the diagram to download a full size PDF file that you could print and distribute.

Tags: H1N1 swine influenza, Virus Infections, Wash Your Hands

The H1N1 Influenza Pandemic

The major determinant of the severity of an influenza pandemic, as measured by the number of cases of severe illness and deaths it causes, is the inherent virulence of the virus. However, many other factors influence the overall severity of a pandemic’s impact.

Even a pandemic virus that initially causes mild symptoms in otherwise healthy people can be disruptive, especially under the conditions of today’s highly mobile and closely interdependent societies. Moreover, the same virus that causes mild illness in one country can result in much higher morbidity and mortality in another. In addition, the inherent virulence of the virus can change over time as the pandemic goes through subsequent waves of national and international spread.

Properties of the virus

An influenza pandemic is caused by a virus that is either entirely new or has not circulated recently and widely in the human population. This creates an almost universal vulnerability to infection. While not all people ever become infected during a pandemic, nearly all people are susceptible to infection.

The occurrence of large numbers of people falling ill at or around the same time is one reason why pandemics are socially and economically disruptive, with a potential to temporarily overburden health services.

The contagiousness of the virus also influences the severity of a pandemic’s impact, as it can increase the number of people falling ill and needing care within a short timeframe in a given geographical area. On the positive side, not all parts of the world, or all parts of a country, are affected at the same time.

The contagiousness of the virus will influence the speed of spread, both within countries and internationally. This, too, can influence severity, as very rapid spread can undermine the capacity of governments and health services to cope.

Pandemics usually have a concentrated adverse impact in specific age groups. Concentrated illnesses and deaths in a young, economically productive age group will be more disruptive to societies and economies than when the very young or very old are most severely affected, as seen during epidemics of seasonal influenza.

Population vulnerability

The overall vulnerability of the population can play a major role. For example, people with underlying chronic conditions, such as cardiovascular disease, hypertension, asthma, diabetes, rheumatoid arthritis, and several others, are more likely to experience severe or lethal infections. The prevalence of these conditions, combined with other factors such as nutritional status, can influence the severity of a pandemic in a significant way.

Subsequent waves of spread

The overall severity of a pandemic is further influenced by the tendency of pandemics to encircle the globe in at least two, sometimes three, waves. For many reasons, the severity of subsequent waves can differ dramatically in some or even most countries.

A distinctive feature of influenza viruses is that mutations occur frequently and unpredictably in the eight gene segments, and especially in the haemagglutinin gene. The emergence of an inherently more virulent virus during the course of a pandemic can never be ruled out.

Different patterns of spread can also influence the severity of subsequent waves. For example, if schoolchildren are mainly affected in the first wave, the elderly can bear the brunt of illness during the second wave, with higher mortality seen because of the greater vulnerability of elderly people.

During the previous century, the 1918 pandemic began mild and returned, within six months, in a much more lethal form. The pandemic that began in 1957 started mild, and returned in a somewhat more severe form, though significantly less devastating than seen in 1918. The 1968 pandemic began relatively mild, with sporadic cases prior to the first wave, and remained mild in its second wave in most, but not all, countries.

Capacity to respond

Finally, the quality of health services influences the impact of any pandemic. The same virus that causes only mild symptoms in countries with strong health systems can be devastating in other countries where health systems are weak, supplies of medicines, including antibiotics, are limited or frequently interrupted, and hospitals are crowded, poorly equipped, and under-staffed.

Assessment of the current situation

To date, the following observations can be made, specifically about the H1N1 virus, and more generally about the vulnerability of the world population. Observations specific to H1N1 are preliminary, based on limited data in only a few countries.

The H1N1 virus strain causing the current outbreaks is a new virus that has not been seen previously in either humans or animals. Although firm conclusions cannot be reached at present, scientists anticipate that pre-existing immunity to the virus will be low or non-existent, or largely confined to older population groups.

H1N1 appears to be more contagious than seasonal influenza. The secondary attack rate of seasonal influenza ranges from 5% to 15%. Current estimates of the secondary attack rate of H1N1 range from 22% to 33%.

With the exception of the outbreak in Mexico, which is still not fully understood, the H1N1 virus tends to cause very mild illness in otherwise healthy people. Outside Mexico, nearly all cases of illness, and all deaths, have been detected in people with underlying chronic conditions.

In the two largest and best documented outbreaks to date, in Mexico and the United States of America, a younger age group has been affected than seen during seasonal epidemics of influenza. Though cases have been confirmed in all age groups, from infants to the elderly, the youth of patients with severe or lethal infections is a striking feature of these early outbreaks.

In terms of population vulnerability, the tendency of the H1N1 virus to cause more severe and lethal infections in people with underlying conditions is of particular concern.

For several reasons, the prevalence of chronic diseases has risen dramatically since 1968, when the last pandemic of the previous century occurred. The geographical distribution of these diseases, once considered the close companions of affluent societies, has likewise shifted dramatically. Today, WHO estimates that 85% of the burden of chronic diseases is now concentrated in low- and middle-income countries. In these countries, chronic diseases show an earlier average age of onset than seen in more affluent parts of the world.

In these early days of the outbreaks, some scientists speculate that the full clinical spectrum of disease caused by H1N1 will not become apparent until the virus is more widespread. This, too, could alter the current disease picture, which is overwhelmingly mild outside Mexico.

Apart from the intrinsic mutability of influenza viruses, other factors could alter the severity of current disease patterns, though in completely unknowable ways, if the virus continues to spread.

Scientists are concerned about possible changes that could take place as the virus spreads to the southern hemisphere and encounters currently circulating human viruses as the normal influenza season in that hemisphere begins.

The fact that the H5N1 avian influenza virus is firmly established in poultry in some parts of the world is another cause for concern. No one can predict how the H5N1 virus will behave under the pressure of a pandemic. At present, H5N1 is an animal virus that does not spread easily to humans and only very rarely transmits directly from one person to another.

WHO World Health Organization

Tags: H1N1 Influenza Pandemic, seasonal influenza, H5N1 avian influenza