Health Highlights: Feb. 8, 2006

FDA Reports 25 Deaths From ADHD Drugs Trasylol Linked to Increased Risk of Serious Side Effects Companies Give NIH Millions of Dollars for Research Project Fire, Burn Hazard Prompts Recall of 5.6 Million Floor Fans Scranton Tops List of U.S. Asthma Capitals

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

FDA Reports 25 Deaths From ADHD Drugs

Twenty-five people, including 19 children, died and 54 more suffered serious cardiovascular problems after taking drugs to treat attention deficit hyperactivity disorder between 1999 and 2003, the U.S. government reported Wednesday.

Children accounted for 26 of the cases of nonfatal cardiovascular cases, which involved heart attack, stroke, hypertension, palpitations and arrhythmia, according to the Food and Drug Administration report.

The report also includes data on 26 other deaths between 1969 and 2003 involving ADHD drug patients, including suicides, intentional overdoses, drowning, heat stroke and from underlying disease, according to the Associated Press.

The report was released a day before the FDA's Drug Safety and Risk Management advisory committee was to discuss new ways of examining the potential cardiovascular risks of the drugs, which include amphetamines such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin and Metadate.

Death and injury reports led the FDA's Canadian counterpart, Health Canada, to remove Adderall XR from the market for six months last year. A Canadian panel eventually concluded there was inadequate evidence of increased harm from Adderall XR compared with other available therapies, a conclusion the FDA also reached based on data on hand.

The FDA review released Wednesday found fewer than one adverse event -- a death or serious injury -- per 1 million ADHD drug prescriptions filled, with the sole exception of the 1.79 cases per million of nonfatal cardiovascular or cerebrovascular problems reported in adults treated with amphetamines. Also, in some of the cases, the children who died were later found to have had undiagnosed heart conditions. And in three of the five cases of death in adults receiving amphetamine treatment, the patients had pre-existing hypertension.

However, the report noted, the rare occurrence of sudden death in children treated with drugs for ADHD "warrants close monitoring." One possibility would be to add labeling to the drugs, the report concluded.


Trasylol Linked to Increased Risk of Serious Side Effects

Trasylol, a drug used to prevent blood loss during surgery, has been linked to increased risk of kidney problems, heart attacks and strokes in patients who have artery bypass graft surgery, the U.S. Food and Drug Administration said in a public health advisory Wednesday.

The link between the drug and these side effects was noted in two recently published studies. The FDA advisory is directed at doctors who perform heart bypass surgery and their patients.

"FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications. We're working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement.

The FDA advisory recommends that:

  • doctors who use Trasylol should monitor patients for toxicity, particularly to the kidneys, heart or central nervous system and promptly report adverse events to drug maker Bayer or through the FDA Medwatch program.
  • doctors should consider limiting the use of the drug to situations in which the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs potential risks.
  • patients should discuss all major risks for heart bypass surgery with their doctors, including risks for bleeding and ways to lessen bleeding risk.


Companies Give NIH Millions of Dollars for Research Project

Drug maker Pfizer Inc. and biotech company Affymetrix Inc. are giving the U.S. government's National Institutes of Health millions of dollars for research into genetic causes of diseases.

Despite the large contributions, the NIH said the information gathered by the Genetic Association Information Network project won't become the properties of the two companies, but will be available to all scientists, the Associated Press reported.

Pfizer will donate $5 million, plus $15 million in laboratory studies, to do genetic analysis for five common diseases. Affymetrix, a leading maker of gene-analysis equipment, is donating resources for DNA analysis of two other diseases.

The NIH is also asking Congress for a $40 million budget increase to fund research into the link between genetic susceptibility to disease and environmental triggers such as diet, pollution, and infections, the AP reported.


Fire, Burn Hazard Prompts Recall of 5.6 Million Floor Fans

A serious burn and fire hazard linked to electrical failure has prompted the recall of about 5.6 million floor fans made by Lasko Products Inc. of Pennsylvania, the U.S. Consumer Product Safety Commission said Wednesday.

There have been 42 reports of fires, including at least eight that resulted in major property damage, associated with motor failures on the fans. There have been seven reports of injuries, including burns and smoke inhalation.

The recall includes various models of Lasko, Galaxy and Air King fans made between January 1999 and July 2001, and sold through February 2004. The fans were sold at discount department stores across the United States from September 2000 through February 2004 for between $10 and $25.

Consumers should stop using these fans immediately and contact Lasko to receive a free fan-protection cord adaptor.

Detailed information on the recalled fans can be found at the Lasko Web site. Consumers can phone the company toll-free at 1-800-984-3311.


Scranton Tops List of U.S. Asthma Capitals

Scranton, Richmond, Philadelphia, Atlanta and Milwaukee, in that order, are the top five worst U.S. cities when it comes to asthma risk factors and quality of life for people with asthma, says the third annual ranking of 100 major metropolitan areas released Wednesday by the Asthma and Allergy Foundation of America (AAFA).

Rounding out the top 10 worst cities are: Cleveland, Greensboro, Youngstown, Saint Louis, and Detroit.

The rankings are based on 12 factors from three categories -- prevalence, risk and medical factors. Risk factors, such as annual pollution and ozone levels, pollen counts, and public smoking bans, carried the most weight in the rankings.

Scranton and Richmond recorded some of the highest pollen levels, a major problem for people with asthma.

"There's no such thing as an 'asthma-free' city, so moving won't solve the problem. What is important is that people understand what triggers an asthma attack and where to look for help to get the right specialist and treatment," Mike Tringale, AAFA director of communications, said in a prepared statement.

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