EBD Blog

Today the US Food and Drug Administration conducts hearings about research on pharmacologic treatments for Attention Deficit-Hyperactivity Disorder, according to Joanne Silburner, reporting for National Public Radio. The hearings are more specifically about safety and follow on Canadian decisions showing risk with such drugs, especially Adderall.

A year ago today, Health Canada suspended sales of Adderall. After further review, Health Canada allowed sales of it again in August of 2005. The FDA’s Durg Saftey and Risk Management Advisory Committee will convene in Gaithersburg, MD (US), to gather evidence about how to design studies to assess risks of medical management of ADHD. Here’s a snip from the agenda:

Cases of sudden death and serious adverse events including hypertension, myocardial infarction, and stroke have been reported to the agency in association with therapeutic doses of drugs used to treat Attention Deficit Hyperactivity Disorder (ADHD) in both pediatric and adult populations. The few controlled clinical studies of longer term drug treatment of ADHD provided little information on cardiovascular risks.

On February 9, 2006, the committee will be asked to discuss approaches that could be used to study whether these products increase the risk of adverse cardiovascular outcomes.

Link to Ms. Silburner’s story (available after 10 AM EST 9 February). Link to Health Canada’s news release about the resumption of sales of Adderall. Link to the FDA statement about Adderall after Canada Health suspended sale of it. Link to the FDA committee’s page describing the agenda and providing links to additional information about the issue.