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.