ADHD Drug Safety Faces More Scrutiny
Posted on: Sunday, 8 January 2006, 12:00 CST
By ANDREW BRIDGES Associated Press
WASHINGTON -- Reports of sudden deaths, strokes, heart attacks and hypertension in both children and adults who take drugs to treat attention deficit hyperactivity disorder are spurring new government study of the safety of the medications.
Sales of drugs to treat ADHD have increased sharply in recent years, with the fastest growth in use among adults rather than children, according to a recent study by Medco Health Solutions, a prescription benefit manager. IMS Health, a pharmaceutical information and consulting firm, said spending on ADHD drugs soared from $759 million in 2000 to $3.1 billion in 2004.
The Food and Drug Administration said it had received reports of what it called "serious adverse events" -- including deaths -- in association with the therapeutic use of the drugs. The agency considers the reports "rare though serious," the FDA's spokeswoman Susan Bro said Wednesday.
The FDA's Canadian counterpart, Health Canada, yanked the ADHD drug Adderall XR from the market for six months last year in response to reports of 20 sudden deaths and 12 strokes in adults and children using the drug. A number of the cases involved children with structural heart defects.
The 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.
Now the U.S. agency is asking its Drug Safety and Risk Management advisory committee to examine ways to study further the potential cardiovascular risks of the drugs.
"It almost sounds like cox-2 inhibitor redux," said the panel's chairman, Dr. Peter Gross, referring to cox-2 painkillers such as Vioxx and Bextra that were pulled from the market because of evidence that they can add to the risk of a heart attack or stroke.
The committee is to meet Feb. 9 and 10 in Gaithersburg, Md.
Arthur Levin, the FDA committee's consumer representative, said: "The issue of drug treatment of attention deficit disorder in children has been a controversial one without this issue of cardiovascular risk too. It adds another concern to what will certainly be an interesting conversation."
A posting to the FDA Web site did not identify any of the drugs by name. However, the most commonly used ADHD drugs include Adderall XR, made by Shire Pharmaceuticals, and Ritalin, made by Novartis Pharmaceuticals Corp. Other companies make generic versions of Ritalin.
A Shire spokesman, Matthew Cabrey, said the company hadn't been told of the meeting but added that it may send representatives. Novartis did not immediately return a call seeking comment.
The committee's Feb. 10 meeting will include updates on FDA actions on cox-2 drugs as well as a recently begun patient, doctor and pharmacist registry program for the anti-acne drug Accutane and its generic competitors.
Food and Drug Administration:
www.fda.gov
Medco Health Solutions:
www.medcohealth.com
Source: Tulsa World
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