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Boost safety warning for attention-deficit drugs, U.S. panel recommends

Health

CBC || February 13, 2006

[KDR: 1 in 22 (1.5 million) people in Canada is on Ritalin or Ritalin-related drugs in 2003. To me this is a very disturbing statistic. The article reports it like it is nothing to be concerned with.]

Related - Ritalin: The Cover-up of Suicides

Stronger warning labels should be placed on Ritalin and other drugs prescribed to treat Attention Deficit Hyperactivity Disorder, a U.S. advisory panel said on Thursday.

The U.S. Food and Drug Administration raised safety concerns about the medications after studies suggested a link between the drugs and an increased risk of sudden death or serious cardiovascular problems, including heart attacks.

The regulator's advisory panel narrowly voted in favour of asking for "black box" warnings, the strongest type, to be added to ADHD drugs. The FDA isn't required to follow recommendations from advisory committees but usually does.

The drugs already have warnings that they could pose a risk to people with heart defects.

Millions of children and adults who take the drugs, such as Ritalin and Adderall, should be given a user-friendly guide outlining possible side-effects, the panel recommended.

"The data is only suggestive at this point, but because of the gravity of the side-effect, namely sudden death, physicians need to be made clearly aware of that concern," said Dr. Peter Gross, the panel's chair, and head of internal medicine at Hackensack University Medical Center in New Jersey.



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Panel member Dr. Curt Furberg agreed, saying it would be "inappropriate, unethical behaviour" for the FDA not to tell doctors and patients about the uncertainty surrounding the safety of ADHD drugs.

Drug manufacturers say there is no evidence of increased risk of cardiovascular problems in people who take ADHD medication.

Last year, Health Canada briefly ordered the stimulant Adderall XR pulled from shelves.

The department has asked drug makers to use stronger warnings on the labels and include product information with ADHD drugs.

Health Canada's panel eventually concluded there was inadequate evidence of increased harm from such medication.

ADHD affects three to seven per cent of school-aged children, according to the American Psychiatric Association.

In Canada, the total number of prescriptions written for Ritalin and Ritalin-related drugs in 2003 was nearly 1.5 million.

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