Reports Of Serious Adverse Events Involving Sudden Death, Heart Attack, and Stroke
Reports of sudden deaths, heart attacks, and strokes in both children and adults taking drugs to treat attention deficit hyperactivity disorder (ADHD) that have been made over time to the FDA has prompted the agency to look anew into the safety of Shire Pharmaceutical's Adderall XR and other ADHD drugs.
Cardiovascular events associated with Adderall and other ADHD drugs will be discussed at meetings of the FDA’s Drug Safety & Risk Management Advisory Committee on February 9 and February 10, 2006 in Gaithersburg, Maryland. Specifically, the FDA wants members on this advisory committee to discuss the development of new studies aimed at determining “whether ADHD products increase the risk of adverse cardiovascular outcomes.”
In an announcement for the February 2006 advisory committee meeting, the FDA said:
- “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."
In February 2005, Health Canada suspended the marketing of Shire’s Adderall XR due to reports of sudden death, heart attacks, and strokes in pediatric and adult patients. Six months later, however, Health Canada reintroduced Adderall to the Canadian market in August 2005 not because the agency found Adderall to be safe but, rather, because "an independent panel found it impossible to accurately ascertain whether the drug increases the risk of cardiac death."
According to reporter Andrew Bridges, in a January 4, 2006 Associated Press article, Dr. Peter Gross, the chairman for this advisory committee, made this noteworthy comment on the paucity of longer-term safety studies for Adderall and other ADHD drugs: "It almost sounds like cox-2 inhibitor redux" -- alluding to the 2004 recall of Vioxx following the "delayed" discovery that Vioxx significantly increased one's risk of having a heart attack or stroke.
Dr. Gross's observation makes one wonder whether Adderall XR, essentially an extended release amphetamine, might be prove to be our next Vioxx-debacle.
(Posted by: Tom Lamb)