Lamisil for Pediatric Treatment of Scalp Ringworm Approved by FDA

The U.S. Food and Drug Administration announced the approval of Lamisil Oral Granules for the treatment of tinea capitis, a fungal infection of the scalp, in children ages 4 years and older.

Tinea capitis most commonly affects children and is often characterized by severe itching, dandruff and bald patches. It is a persistent and contagious fungal infection that usually does not respond to topical treatment.

"Tinea capitis is a persistent infection that is hard to treat, and one that causes children embarrassment," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "A parent's ability to sprinkle it on the food of a child, who may not like to take medicine, should go a long way to helping ensure the infection is properly treated and to limiting its spread."

The FDA, in a pediatric written request, approached Novartis Pharmaceuticals Corporation of East Hanover, N.J., the manufacturer of Lamisil (terbinafine hydrochloride), for a formulation palatable for children. The company formulated the new dosage form, granules, which can be sprinkled on food.

Under the Best Pharmaceuticals Children's Act of 2002, there are market exclusivity incentives to encourage drug manufacturers to conduct pediatric studies to develop clinical information that lead to safe and effective formulations, studies and dosing for pediatric populations. The FDA may only grant a drug pediatric exclusivity if that drug meets specific requirements. The FDA makes a written request to the manufacturer or the company can prompt the agency to make a written request for pediatric studies.

"This is an important step in working with manufacturers to bring to market drug therapies that are formulated for, studied, and dosed in actual pediatric populations," said Dianne Murphy, M.D., director of the Office of Pediatric Therapeutics for FDA. "It is our hope that other drug manufacturers will study and devise therapies specifically for children."

The approved pediatric doses were determined through clinical trials in pediatric populations. Lamisil Oral Granules are approved to be administered once a day for six weeks. The actual dosage amount will be based on the weight of the child.

"Ringworm" is a misleading term that refers to the circular appearance of the fungal lesion. There are no worms involved.

Tags: FDA, Ringworm, Scalp ringworm, fungal lesion, pediatric, Best Pharmaceuticals Children's Act, Lamisil, Novartis

Congress Votes To Add More Children to SCHIP

AP reports, WASHINGTON, Sep. 27, 2007 - Congress approved legislation Thursday that would potentially add 4 million children to a popular health care program, setting up a veto fight that President Bush probably will win but handing Democrats a campaign issue for next year's elections.

Eighteen Republicans in the Senate lined up with Democrats in voting 67-29 to increase spending on the State Children's Health Insurance Program, or SCHIP, from about $5 billion to $12 billion annually for the next five years.

The vote was enough to override a promised Bush veto. But supporters in the House, which passed the bill Tuesday, are about two dozen votes shy of an override. Both chambers would have to muster two-thirds majorities to win a veto showdown.

Overall, spending for SCHIP would increase to $60 billion over five years in the unlikely prospect the bill becomes law -- double what President Bush recommended.

Analysts projected the legislation would allow about 4 million of the estimated 9 million uninsured children in the United States to gain coverage.

Bush and most GOP lawmakers say the spending increase is too large and would expand the program beyond its original intent. That intent was to help families with incomes too large to qualify for Medicaid but not enough to afford private insurance.

Tags: SCHIP

More Toy Recalls, this Time it is Thomas & Friends wooden railway toys (Images included)

Here are the images of recalled RC2's Thomas and friends line and instructions as provided by RC2 to recognize them.

• Please check the tracking code on the bottom of the vehicle as shown in the circled image above. Only those vehicles that have either no tracking code or the following tracking codes are subject to this recall.

26833i 28233i 23243i00 24643i00

25343i00 27443i00 32043i00 34743i00

The affected All Green Maple Tree Top was found exclusively in the Conductor's Figure 8 Set with item number LC99535 or LC99535T.

The affected Green Signal Base was found exclusively in the Conductor's Figure 8 Set with item number LC99535 or LC99535T.


Please check the tracking code on the bottom of the vehicle as shown in the image above. Only those vehicles that have a tracking code 1656OW00 are subject to this recall.
The affected Olive Green Sodor Cargo Box was found exclusively in the Deluxe Cranky the Crane with item number LC99371.

After millions of Chinese-made toys and products have been recalled this summer because of lead contamination in their painted coatings. In separate announcements yesterday, Target and RC2, the maker of Thomas & Friends wooden railway toys, joined the line by recalling 550,000 toys.
The toys being recalled are five products from the Thomas & Friends product line: a black cargo car, a Toad vehicle, an olive green Sodor Cargo Box, a green maple tree and signal base accessories.
RC2 had the following message on the site;
In cooperation with the CPSC, RC2 issued a voluntary recall on September 26, 2007 for five additional items from the Thomas & Friends™ Wooden Railway that were produced between March 2003 and April 2007.
learn more or visit RC2 Recall Website.

It is easier to mark "Chinese Made" but I have a simple question, who gives the designs and specifications, is it Chinese Toy makers too? It is very simple folks, Toy companies are business' and they out there to make money and not to check you kids health. They will cut corners and blame others (Chinese) and apologize when the heat is low like Mattel did. I think it is worth while to save your kids and return all the toys. So that next time toy makers will check products when the orders come back from manufacturers. From the above statement, it is evident that since 2003, our kids were playing with toys with lead and nobody tested them.

I have played with a lots of toys when I was a kid (I still have some of them ;)) and I do not recall any of them needing recalls. May be because they did not know better then. But the US law concerning Lead based paint on toys were enacted in 1970s and the companies do very well know about it. They also have means of testing once products come in from manufacturers. If the manufacturers are cutting corners then it is due to lack of concern by US companies that lead to have our children play with lead laden toys!.
“It’s absolutely astonishing to us that lead continues to be found in children’s toys despite the fact that consumer and environmental groups have been warning the government about this issue” for more than 10 years, said Mr. Schade, whose group, The coalition of environmental and consumer groups, coordinates a national campaign to phase out vinyl plastics from consumer products and packaging.

Tags: toy recall, target, rc2, thomas & friends, Sodor Cargo Box, toad, Green Maple Tree top, cargo car

Taking Fatty Acid Supplements (Omega-3, Omega-6) Could Improve Behavior and School Performance in Kids With Developmental Coordination Disorders

The Children’s Hospital of Denver, Colorado had this fine article reviewed and published and thought it to be a good bit of news.

Children with coordination disorder (DCD) - which affects about 5% of school-age children - may have learning, behavior, and social difficulties that last into adulthood. Some research has suggested that nutritional deficiencies or imbalances may contribute to these disorders, so researchers from the University of Oxford in the United Kingdom studied whether supplementing kids' diets with certain fatty acids could improve symptoms of DCDs.

Omega-3 and omega-6 fatty acids are found in certain fats and oils and are necessary for normal brain development and function. In this study, 117 5- to 12-year-old children with DCD were divided into two groups: One group took a daily food supplement containing omega-3 and omega-6 fatty acids for 1 month; another group took a supplement containing olive oil for 1 month. After a month of not taking any supplements, the groups switched and the group taking the fatty acid supplement took the olive oil supplement and the group taking the olive oil supplement took the fatty acids for a month. After the initial 3-month study, some of the children continued to take the fatty acid supplements for an additional 3 months. Throughout the study, the children took tests to measure motor function, spelling and reading ability, and symptoms of attention deficit hyperactivity disorder.

The fatty acid supplements didn't affect a child's coordination or motor skills. However, after taking the fatty acid supplements, children experienced significant improvements in reading, spelling, and behavior. Children who continued to take the fatty acid supplements until the 6-month mark tested more than a year ahead of their previous reading level and more than 6 months ahead of their previous level of spelling. None of the kids in the study had any side effects as the result of taking the supplements.

What This Means to You: Although fatty acid supplements didn't improve coordination in children with DCD, however, the results did shown that kids with DCD in this study, the children did show improvement in reading, spelling, and behavior. If your child has DCD, your child's doctor may recommend nutritional supplements, such as omega-3 and omega-6 fatty acids. These fatty acids are also found in certain types of fish, including albacore tuna and salmon, which can be a healthy part of your child's diet.

Source: Alexandra J. Richardson, DPhil; Paul Montgomery, DPhil; Pediatrics, May 2005

Reviewed by: Steven Dowshen, MD
Date reviewed: June 2005

Original Article

Tags: Omega-3, Omega-6, fatty acids, DCD, Pediatrics, hyperactivity, attention deficit hyperactivity disorder

Breast Cancer Deaths are Falling Continuously.

The breast cancer death rate in the United States continues to fall by around 2% a year, as it has since 1990, according to Breast Cancer Facts & Figures 2007-2008, a report on breast cancer statistics and trends produced every other year by the American Cancer Society. That's an impressive winning streak for an important indicator of success in the fight against cancer, made possible in large part, the report says, by advances in early detection and treatment.
I also think movements like pink ribbon, breast cancer awareness helped by educating the people. But one sad fact is that black women are not seeing the same benefits as whites, the American Cancer Society.
Learn more about this information and more at the American Cancer Society.
Breast Cancer Deaths are Falling Continuously.

Tags: the American Cancer Society, pink ribbon, breast cancer

Depression Management by Phone at workplace is a Win-Win Situation

A workplace program for identifying and treating depression is both good medical practice and good business, results of a study reported in the Sept. 26 issue of Journal of the American Medical Association. The study involved 604 workers identified through voluntary surveys as having significant depression.
Many employers view mental health coverage as a financial black hole, but the study shows that spending money on depression is a smart business move, said researcher Dr. Philip Wang. Wang works for the National Institute of Mental Health, which funded the study.
Employees who got the aggressive intervention worked on average about two weeks more during the yearlong study than those who got the usual care — advice to see their doctor or seek a mental health specialist.
The entire publication;
"Telephone Screening, Outreach, and Care Management for Depressed Workers and Impact on Clinical and Work Productivity Outcomes: A Randomized Controlled Trial." is available at JAMA (Journal of the American Medical Association) for free.

Tags: JAMA, depression, Mental Health, National Institute of Mental Health

Sleep, less or more will hurt you the same!

LONDON (Reuters) - People who do not get enough sleep are more than twice as likely to die of heart disease, according to a study released on Monday.

Although the reasons are unclear, researchers said lack of sleep appeared to be linked to increased blood pressure, which is known to raise the risk of heart attacks and stroke.

A 17-year analysis of 10,000 government workers showed those who cut their sleep from seven hours a night to five or less faced a 1.7-fold increased risk of death from all causes and more than double the risk of cardiovascular death.

The findings highlight a danger in busy modern lifestyles, Francesco Cappuccio, professor of cardiovascular medicine at the University of Warwick's medical school, told the annual conference of the British Sleep Society in Cambridge.

The correlation with cardiovascular risk in those who slept less in the 1990s than in the 1980s was clear but, curiously, there was also a higher mortality rate in people who increased their sleep to more than nine hours.
Read more..

Tags: health, sleep, heart disease

Nasal Influenza Vaccine Approved by FDA

The U.S. Food and Drug Administration today approved expanding the population for use of the nasal influenza vaccine FluMist to include children between the ages of 2 and 5.
Approval for the vaccine, which contains a weakened form of the live virus and is sprayed in the nose, was previously limited to healthy children 5 years of age and older and to adults up to age 49.
“The goal of preventing influenza is now more attainable with the availability of FluMist for younger children,” said Jesse L. Goodman, M.D., director, FDA’s Center for Biologics Evaluation and Research. “This approval also offers parents and health professionals a needle-free option for squeamish toddlers, who may be reluctant to get a traditional influenza shot.”
The U.S. Centers for Disease Control and Prevention recommends that all children age 6 months to 59 months receive a vaccination to protect against influenza. Studies have shown that children younger than 5 years had rates of influenza-associated hospitalizations similar to those among individuals age 50 through 64 years, emphasizing the need for improved influenza prevention efforts for this younger U.S. population.

However, until today, there have been only two vaccines licensed in the U.S. for children under the age of 5. One influenza vaccine, Fluzone, is indicated for people over 6 months of age, while another vaccine, Fluvirin, is available for use in children age 4 and older.

Approximately 6,400 infants and children age 6 months to 59 months received FluMist in three studies to support the vaccine’s safety and effectiveness. Two studies compared FluMist to placebo (no vaccine), both of which demonstrated the vaccine’s effectiveness in preventing influenza illness. A third study compared FluMist to an inactivated or “killed” seasonal influenza vaccine shot. The results showed that there were 53 cases of influenza disease among 3,900 children who received FluMist compared to 93 cases among the same number of children who received an inactivated or “killed” seasonal influenza vaccine shot. Children under the age of 2 should not receive FluMist because there was an increased risk of hospitalization and wheezing for this age group during the clinical trials.
Commonly observed adverse events from the vaccine were generally mild and most often included runny nose and/or nasal congestion, as well as a slight fever in children 2 to 6 years of age.
FluMist should not be administered to anyone with asthma or to children under the age of 5 years with recurrent wheezing because of the potential for increased wheezing after receiving the vaccine. People who are allergic to any of FluMist’s components, including eggs or egg products, should also not receive the vaccine.FluMist is manufactured by MedImmune Vaccines, Inc., Gaithersburg, Md. Fluvirin is made by Novartis Vaccines and Diagnostics Ltd, Liverpool, England. Fluzone is manufactured by sanofi pasteur Inc., Swiftwater, Pa.

News release

Tags: FluMist, nasal influenza vaccine, influenza, Fluzone, children, asthma, under the age of, Novartis Vaccines, Fluvirin

Encourage Flu shots, CDC advises

Encourage Flu shots!, national health officials today called on healthcare professionals and the public to improve the "alarmingly low" vaccination rates of recent years.

The Centers for Disease Control and Prevention (CDC) said up to 132 million doses of flu vaccine are expected to be available this year. Last year about 121 million doses were produced, of which 102.5 million were distributed, leaving at least 18 million unused, CDC officials said.

"We expect to have the largest supply we've ever seen," CDC Director Dr. Julie Gerberding said at a news conference today from the National Press Club in Washington. She said the production and distribution delays that hurt vaccination coverage last year are not expected this year.

CDC officials complained of persistently low vaccination coverage rates in many groups who should be immunized. In 2005-06, for example, only 18% of children aged 6 to 23 months received shots, and the immunization rate for health care workers has been stuck at about 40% for the last 10 years.

CDC Flu prevention and Control

Tags: CDC, flu, vaccination, Centers for Disease Control and Prevention, influenza

CDC Report, The first changes in suicide rates among 10-24 year olds in more than 15 years.

Release of the study, "Suicide Trends Among Youths and Young Adults Aged 10-24 Years - United States, 1990-2004," was published on seventh September in the Centers for Disease Control and Prevention's (CDC) Morbidity and Mortality Weekly Report (MMWR).

I only know too well as I helped a mother who lost a child due to suicide about three years ago, a girl.

Study results show the largest increase in youth and young adult suicide rates in 15 years. The most noted change occurred in hanging/suffocation suicides among 10-14 year old girls.

From 1990 through 2003, the total suicide rate for 10 to 24 year olds declined by 28.5 percent (9.48 to 6.78 deaths per 100,000), however, between 2003 and 2004, the overall rate of suicide climbed among this age group by 8 percent (6.78 to 7.32 deaths per 100,000), the largest single-year rise in 15 years. It is important for parents, health care professionals, and educators to recognize the warning signs of suicide in youth such as talking about taking one’s life, feeling sad or hopeless about the future. Parents should also look for changes in eating or sleeping habits and even losing the desire to take part in favorite activities.

Between 1990 and 2003, the overall suicide rate for 10-24 year olds declined by 28 percent. Between 2003 and 2004, however, the rate climbed by 8 percent, the largest single-year climb in 15 years. The rate of hanging/suffocation suicides among 10-14 year old girls more than doubled between 2003 and 2004, increasing by 119 percent. In 2004, approximately 161,000 youth and young adults between the ages of 10 and 24 received medical care for self-inflicted injuries at Emergency Departments across the United States.

Tags: CDC, MMWR, teen suicide, teen suicide prevention, suffocation suicides, hanging, suicides

What you should know about Bioterrorism

Spurred by the horrendous events of September 11, 2001, the Food and Drug Administration has worked to prevent and mitigate the effects of bioterrorism, and to be prepared if a bioterrorist attack should ever occur.

"We've made very important contributions toward protecting the nation against its enemies," says Boris Lushniak, MD, MPH, FDA's Assistant Commissioner for Counterterrorism Policy.
Bioterrorism refers to a deliberate release of viruses, bacteria, fungi or toxins from living organisms to cause illness or death in people, animals, or plants. Harmful agents can be spread through the air, water, or in our food.
In the event that a biological agent is released in the United States, FDA would work closely with federal, state, and local authorities to investigate the problem and get contaminated products off the market quickly.
"FDA's role is very challenging," says Lushniak, who leads FDA's Office of Counterterrorism and Emerging Threats (OCET). "We need to balance public health needs, regulatory requirements, and science, as we assist with defense of the nation."

Above is an extract from a larger collection of articles and information ad FDA. You can learn more by following the links provided below;

A Stronger Defense Against Bioterrorism

FDA's Counterterrorism Web page
www.fda.gov/oc/opacom/hottopics/bioterrorism.html

CARVER + Shock
www.fda.gov/consumer/updates/carvershock061107.html

Tags: Counterterrorism, OCET, FDA, public health, Bioterrorism

FDA approves, Evista for breast cancer prevention

Yesterday, the U.S. Food and Drug Administration approved the drug raloxifene to reduce breast cancer risk in two groups of post menopausal women: those with the bone-thinning condition osteoporosis and those at high risk for invasive breast cancer.

More than 500,000 women in the United States already take the drug, whose brand name is Evista, manufactured by Indianapolis-based Eli Lilly. The FDA approved its use years ago to prevent or treat osteoporosis in postmenopausal women.

In a statement yesterday, Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said the expanded use of Evista "provides an important new option for women at heightened risk of breast cancer."

"Because Evista can cause serious side effects, the benefits and risks of taking Evista should be carefully evaluated," he said. "Women should talk with their health care provider about whether the drug is right for them."

Dr. Lawrence Wickerham, chief of medical genetics and cancer prevention at Allegheny General Hospital's breast cancer center, called the announcement "extraordinarily good news for postmenopausal women at increased risk for future breast cancer."

source

FDA Approves New Uses for Evista

Tags: FDA, Food and Drug Administration, post menopausal, raloxifene, breast cancer, Evista, Eli Lilly

Toys "R" Us offers a safty notification site

NEW YORK (Reuters) - Retailer Toys "R" Us said on Wednesday that it is expanding its efforts to inform shoppers of the latest toy recalls after a slew of Chinese-made toys were pulled from store shelves this summer due to unsafe levels of lead paint.

The retailer said it has launched a toy safety Web site -- www.Toysrus.com/Safety -- that includes information about its safety procedures and specific recall information. Toys "R" Us also said it is introducing an e-mail notification system for recalls and adding bilingual recall notices.

"We are also moving to require that our vendors submit to us certification of testing for each batch coming to Toys "R" Us," Chief Executive Jerry Storch said in prepared remarks to be given to a Senate subcommittee.

Tags: toy recall, child safty, toysrus, toys r us, lead paint

Dietary supplement Zencore Tabs recalled

The maker of Zencore Tabs, marketed as a dietary supplement to enhance male sexual stamina, is recalling the product because it contains undeclared ingredients including aminotadalafil and sildenafil, chemicals whose derivatives are used in prescription medicines for erectile dysfunction, the U.S. Food and Drug Administration said Friday.
These and two other chemical ingredients, sulfosildenafil and sulfohomosildenafil, may interact with nitrates found in certain prescription drugs and could lower blood pressure to dangerous levels, the FDA said in a statement.
Zencore is marketed by Los Angeles-based Bodee LLC.
Consumers who have this product are urged to stop using it immediately and to see a health-care professional if they notice any side effects, the FDA said.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The company advises that any unused portion be returned to Bodee LLC for a full purchase price refund by calling (800) 935-0296 for instructions on the return and refund process.The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Zencore Tabs’ composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.

Tags: Zencore Tabs, Zencore Tabs recall, aminotadalafil, sildenafil, erectile dysfunction, Bodee LLC, FDA, Medwatch

Blue Shield California Foundation Launches Clinic Leadership Institute

SAN FRANCISCO--(BUSINESS WIRE)--Blue Shield of California Foundation (BSCF) today announced plans to spend up to $10 million over 5 years to support its first signature project, the Clinic Leadership Institute, an innovative program that aims to identify and train the next generation of California’s community clinic leaders.

The Clinic Leadership Institute is being launched with an initial grant of $1.39 million, which was part of this year’s third quarter grant making. The funding will be used to recruit, select and train the inaugural class of 25 emerging clinic leaders. Those selected will learn leadership, decision making, financial management and strategic planning skills during the course of the 18 month Institute. The goal is to provide these emerging leaders with the skills to become effective change agents in today’s rapidly evolving health care environment.

“Community-based clinics today face a major leadership transition,” said BSCF President and CEO Crystal Hayling. “Those who pioneered the community-based clinic movement had the vision to establish our healthcare safety net. As 70 percent of today’s community clinic leaders prepare to retire, the Clinic Leadership Institute will prepare a new generation to take the helm.”

Community clinics are a vital part of California’s healthcare safety net. Today, more than 800 clinics throughout California provide healthcare services to nearly 3 million people, including 12 percent of California’s children and 37 percent of those living below the poverty level.

The Clinic Leadership Institute grows out of BSCF’s deep and longstanding commitment to supporting California’s healthcare safety net. Since 2003, BSCF has provided $29 million in core support funding to community clinics statewide.

“As a result of this program, we hope the next generation of healthcare leaders will be better prepared to serve the millions of Californians who rely on community clinics for the care they need to keep themselves and their families well,” Hayling said. “We hope to build a learning network of clinic leaders.”

BSCF selected the Center for the Health Professions at the University of California – San Francisco (UCSF) to develop and administer the Clinic Leadership Institute. Developed with input from California community clinic representatives, as well as regional and national experts in the field of leadership development, the Institute offers a comprehensive curriculum and hands-on training that addresses core competencies in:

• Organization Values and Behaviors
• Leadership and Decision Making
• Strategic Thinking and Acumen
• Business Acumen and Financial/Grant Management
• Relationship Management
• Diversity
• Organization Improvement
• Data Driven Decision Making

The Clinic Leadership Institute is now accepting applications for its inaugural class, with a deadline of October 31, 2007. Applicants will be recruited from every region of the state and will be representative of its full economic, social and cultural diversity. Those interested in more information should visit www.clinicleadershipinstitute.org.

Tags: Blue Shield, BSCF, Clinic Leadership Institute, health care, healthcare, University of California, UCSF

Popcorn suppliers drop toxic chemical diacetyl

ConAgra, the world's largest supplier of the 3 billion bags of microwave popcorn sold each year, said Tuesday that it will eliminate the use of a controversial chemical butter flavoring linked to severe lung disease in workers from its Act II and Orville Redenbacher products.
The announcement comes a week after Pop Weaver, the nation's second-largest popcorn producer, said it already had pulled the synthetic flavoring -- diacetyl -- from its microwave product delivered to stores last month.
Meanwhile, a lung specialist from Denver's National Jewish Medical and Research Center has notified federal agencies that she may have identified the first known case of a man who ate popcorn at home and had the same disease as the workers.
Lung specialist Dr. Cecile Rose wrote to the Food and Drug Administration, the Environmental Protection Agency, the Centers for Disease Control and Prevention and the Occupational Health and Safety Administration in July, advising them of her patient and the possibility that people who pop microwave corn at home can be at risk.
The rare lung disease that Rose diagnosed in her patient -- bronchiolitis obliterans -- can cause death in severe cases. Lung transplants are the only hope that patients have. The disease quickly leads to breathing difficulties and is often misidentified by physicians unfamiliar with the disease.
news source

Tags: popcorn, ConAgra, Act II, Orville Redenbacher, Pop Weaver, diacetyl, FDA, bronchiolitis obliterans

Mattel Announces Recall of Additional 11 Toys as a Result of Extensive Ongoing Investigation and Product Testing

EL SEGUNDO, Calif., Sept. 4 /PRNewswire-FirstCall/ -- Mattel, Inc. announced today that, as a result of the company's ongoing investigation of its toys manufactured by vendors in China, the company has voluntarily recalled 11 toys globally, including eight pet and furniture playsets sold under the Barbie(R) brand and three Fisher-Price(R) toys, due to impermissible levels of lead. No Barbie(R) dolls are included within the recall. In total, there are 522,000 affected toys in the U.S., and 322,000 affected toys outside of the U.S. Mattel has completed the testing program for the majority of its toys, including all of its toys currently sourced from vendors.

The voluntary recall results from Mattel's thorough investigation of vendor-sourced toys. Mattel has also globally implemented a strengthened, three-point check system to test toys throughout the manufacturing process.

"In August we promised that we'd continue to focus on ensuring the safety and quality of our toys through extensive testing of finished products, thorough investigation of our vendors and the implementation of a strengthened three-point check system. As a result of our ongoing investigation we discovered additional affected products. Consequently, several subcontractors are no longer manufacturing Mattel toys. We apologize again to everyone affected and promise that we will continue to focus on ensuring the safety and quality of our toys," said Robert A. Eckert, chairman and chief executive officer, Mattel.

In the U.S., there are seven recalled Barbie(R)-branded toys. The specific affected parts include:

    -- Dream Puppy House(TM)- orange on miniature dog
   -- Dream Kitty Condo(TM)- brown on miniature cat
   -- Table & Chairs Kitchen Playset - yellow food on two dinner plates,
      brown on miniature dog, yellow and orange on potato chip bowl, orange
      on salad bowl
   -- Bathtub & Toilet Playset - brown on miniature cat
   -- Desk & Chair Bedroom Playset - brown on miniature dog
   -- Living Room Playset (deluxe) - brown on miniature cat
    -- Living Room Playset (premium) - yellow flower on purse

The playsets affected by the recall were produced by Holder Plastic Company (Holder), a Mattel contract vendor, which subcontracted the painting of miniature toy pets and small furniture pieces to Dong Lian Fa (DLF) and Yip Sing (YS). DLF and YS used uncertified paint and are no longer producing toys for Mattel.

Mattel's investigation revealed that the subcontractors painted the affected toys between March 2007 and August 2007. However Mattel is being cautious and recalling the entire production of the seven toys painted by the subcontractors. Therefore, toys manufactured beginning in October 2006 are included within the recall. The toys being recalled were sold at retail between November 2006 and August 2007.

Among the three Fisher-Price(R) toys recalled are two Fisher-Price(R) GEOTRAX(TM) toys and one "It's a Big Big World" toy. Fisher-Price(R) toys with specific parts affected include:

    -- GEOTRAX(TM) Rail & Road System Freightway Transport(TM)- yellow
      headlights on train car and miniature ladder
   -- GEOTRAX(TM) Special Track Pack(TM) - yellow headlights on train car and
       miniature ladder
   -- "It's a Big Big World" 6-in-1 Bongo Band - painted decal on top of
      clear plastic on drum

The two GEOTRAX(TM) toys were manufactured by Apex Manufacturing Company Ltd. (Apex), one of Mattel's contract vendors, which outsourced paint work to a subcontractor, Boyi Plastic Products Factory (Boyi). Apex supplied Boyi with certified paint; however, the toys were manufactured with uncertified paint. Boyi is no longer in business. The two GEOTRAX(TM) toys that tested for impermissible levels of lead were manufactured between July 31, 2006, and September 4, 2006; however, the painted parts were stored and incorporated into toy production throughout the year. Mattel is being cautious and recalling toys shipped between August 3, 2006, and July 31, 2007.

The Fisher-Price(R) "It's a Big Big World" 6-in-1 Bongo Band toy was manufactured by Shun On Factory, one of Mattel's contract vendors, which outsourced the molding and painting of one plastic piece. A subcontractor, Jingying Tampo Printing Processing Factory, used uncertified paint on the affected piece. The "It's a Big Big World" 6-in-1 Bongo Band was manufactured between May 19, 2007, and August 1, 2007.

Mattel is working in cooperation with the U.S. Consumer Product Safety Commission and other regulatory agencies worldwide. Mattel is also working with retailers worldwide to identify and remove affected products from retail shelves.

For additional information regarding this recall, including a full list of affected products, please contact Mattel at (888) 496-8330, or visit the company's Web site at http://www.service.mattel.com. A full list of products is also published by the Consumer Products Safety Commission.

    How to Return Affected Toys/Parts:

   1)  The first step is for consumers to determine if they have a toy that
       has been affected by the recall.  To do so, they can visit
        http://www.service.mattel.com where they will find a complete list of
       each toy recalled, including color photos, toy model numbers and
       affected date codes.  Consumers can locate toy model numbers on the
       bottom of most recalled toys.

       For consumers without a computer, or for those preferring phone
       support, they may call (888) 496-8330

   2)  Once consumers determine that they think they own a Mattel toy
       affected by the recall, they are prompted to fill out a form (online)
       or provide their postal address (via phone), and Mattel will send to
       consumers (via email or to a postal address) a color brochure with
       photos, toy numbers and date code ranges of every affected toy, as
       well as a pre-paid mailing label for return of the affected part(s).

   3)  After receiving consumers' returned, affected part(s), Mattel will
       send consumers replacement parts for each affected product, as well as
       bonus pieces/parts.

Mattel recommends that consumers do not return toys to retailers for three reasons:

    1)  Mattel can help consumers determine if a toy has been affected by the
       recall (vs. returning an unaffected toy)

   2)  Mattel will provide consumers with a replacement part for each toy
        part affected by the recall

   3)  Mattel will handle affected products in an environmentally friendly
       way

Consumers do not need to have the toy's original packaging or a receipt to return affected products to Mattel.

Tags: toy recall, mattel, barbie recall, Fisher-Price

New drug for treating schizophrenia

Eli Lilly and Co. is testing a new drug for schizophrenia that it says works quickly and safely without resulting in weight gain, a much-criticized side effect of its top-selling antipsychotic drug Zyprexa.
The Indianapolis drug maker recently tested the new drug on more than 100 schizophrenic patients for four weeks and found it was effective in treating hallucinations, delusions, social withdrawal and apathy, according to a paper published today in the journal Nature Medicine.
Patients who took the drug, LY2140023, showed no weight increase, nor did they exhibit adverse effects commonly associated with many schizophrenia medications, such as involuntary movements or muscle stiffness, the paper said.
Lilly said the new drug works in a completely different way than standard treatments. Most currently approved antipsychotic medications work by affecting the neurotransmitters dopamine or serotonin. The new drug is thought to work by affecting another neurotransmitter, glutamate.
Lilly said the new drug is still years away from clinical use for schizophrenia, a disease that affects about 3 million Americans.
The first new class of drugs in more than a decade for treating schizophrenia worked at least as well in a clinical trial as standard medications, a study released Sunday showed.
Unlike current anti-psychotic drugs, which block the uptake of a naturally occurring chemical called dopamine, the new drug acts on a different neurotransmitter, glutamate.
The new treatment also reduced certain undesirable side-effects, according to the study, published in the British journal Nature Science.
Imbalances in the brain of these chemicals are largely responsible for schizophrenia's disabling symptoms, which range from hallucinations and delusions to a severely impaired ability to express emotion. Environmental factors are thought to play a role too.
Sufferers often hear voices and may believe that other people are reading their minds or controlling their thoughts. These frightening experiences can cause withdrawal and extreme agitation.
AFP@Google

Tags: schizophrenia, LY2140023, antipsychotic, serotonin

Have You Given Blood Lately? Give Blood, Give Life!

As a mantra, I donate blood every year since I was 14 years old. Why? Because I survived a very bad motorcycle accident and all those donors have donated blood, saved my life. While recovering from the accident, I made a promise to myself that I will donate blood as long as I could, to thank for what I received!

Thanks to God, I have been healthy and I could donate blood without any problems. One thing is that you feel very content and happy that your act will help and save someone somewhere. That someone easily could be somebody very close to you.

So what and how does this blood donation work? FDA, Food and Drug Administration, has a Information page. Please see the end of the post to see additional information and links.

Every day, emergency rooms throughout the United States are challenged by large numbers of people who need blood, including victims of fires, floods, storms, and other disasters.

But it's not just accidents or disasters that prompt the need for blood. Blood is needed for many people ranging from those with life-threatening illnesses to others undergoing routine surgeries.

In fact, every two seconds, according to the American Red Cross, someone in America needs blood, such as

• Cancer patients undergoing chemotherapy
• People with sickle cell disease or other types of inherited anemia
• Organ transplant recipients
• People undergoing elective surgery
• Moms-to-be during and following labor and delivery

The Process of Donating Blood

Blood is critically needed every day, yet only about 5% of the eligible U.S. population donates blood in any given year, according to the American Red Cross. Healthy individuals who meet donor eligibility requirements (see below) are urged to give blood.

The entire procedure takes about an hour and includes:

• Registering at the facility
• Answering questions about your health and travel history
• Getting a physical examination
• Donating the blood (about 10 minutes)
• Having a light refreshment to boost your energy level before leaving the facility

Am I Eligible to Donate Blood?

To meet the basic requirements for giving blood, you must

• be healthy (feel well and be able to perform normal activities)
• be at least 17 years old
• weigh at least 110 pounds
• not have donated blood in the last 56 days

A number of conditions, which will be discussed with you at the donation site, make you temporarily or permanently ineligible to give blood, such as

• pregnancy
• past use of needles to take drugs that were not prescribed by a doctor
• being a male who has had sexual contact with another male since 1977
• getting tattooed in the last year
• living in or visiting certain countries during designated periods of time, for example, living a long time in a country where "mad cow disease" is found or visiting an area where malaria is found.

The rules for eligibility are less strict when making donations for your own use during surgery.

For more information about donor eligibility and giving blood, see

Have You Given Blood Lately?

FDA's Center for Biologics Evaluation and Research
www.fda.gov/cber/faq/bldfaq.htm

American Red Cross
www.GiveLife.org
1-800-GIVE-LIFE (448-3543)

AABB (formerly known as the American Association of Blood Banks)
www.aabb.org/content

America's Blood Centers
www.americasblood.org
1-888-USBLOOD (872-5663)

Tags: FDA, donate blood, America's Blood Centers, AABB, American Association of Blood Banks, American Red Cross

Social Life, Health, and Aging Project (NSHAP)

The National Social Life, Health and Aging Project (NSHAP) is the first population-based study of health and social factors on a national scale, aiming to understand the well-being of older, community-dwelling Americans by examining the interactions among physical health, illness, medication use, cognitive function, emotional health, sensory function, health behaviors, and social connectedness. It is designed to provide health providers, policy makers, and individuals with useful information and insights into these factors, particularly on social and intimate relationships. NORC, with Principal Investigators at the University of Chicago, conducted more than 3,000 interviews during 2005 and 2006 with a nationally representative sample of adults aged 57 to 85. Face-to-face interviews and biomeasure collection took place in respondents' homes.
Data collection elicited:
1) demographic characteristics;
2) social networks;
3) social and cultural activity;
4) physical and mental health including cognition;
5) well-being;
6) illness;
7) medications and alternative therapies;
8) history of sexual and intimate partnerships; and
9) patient-physician communication.
NSHAP also collected important health information in the home, prioritizing non-invasive collection techniques and cutting edge technology that minimizes respondent burden. NSHAP plans to conduct follow-up interviews with respondents every three years to collect longitudinal data.
This invaluable data is made available to public through ICPSR.

Tags: Aging Project, NSHAP, Face-to-face interviews, biomeasure collection, physical health, illness, medication use, cognitive function, emotional health, sensory function, health behaviors, social connectedness