Tuesday, January 10, 2006

ADHD Drugs: Storm brewing? FDA involvement?

There have been reports of deaths, strokes, heart attacks and hypertension in children and adults who take drugs to treat ADHD disorders, and this has led to our trusted government's desire to dig deeper.

The FDA's reps have said it had received reports of "adverse events" -- including deaths -- when the drugs are used.

Health Canada pulled Adderall XR for six months in 2005 after they received 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. (Health Canada site, here)

Now the FDA wants its Drug Safety and Risk Management advisory committee to look at how it may study cardiovascular risks of the drugs. Longer-term use of ADHD drugs provide little information on those risks that may exist.

Dr. Peter Gross is a committee chairman who has been quoted as comparing this potential problem to the issues revolving around Cox-2 painkillers like Vioxx and Bextra pulled from the market because of evidence they can raise the risk of a heart attack or stroke. The committee is to meet Feb. 9 and 10 in Gaithersburg, Md. (See various reports, including Yahoo reports and Reuters).

The FDA web site doesn't list the drugs by name. Popular ADHD drugs include Adderall XR and Ritalin.

My comment: I found this on the Reuters site to counter the concerns:

Drugs to treat attention deficit hyperactivity disorder (ADHD) are generally safe, some doctors said on Thursday after U.S. health officials announced a meeting to discuss possible heart risks.

"It's not a big deal for patients without a cardiac history," Dr. Adelaide Robb, a psychiatrist at Children's National Medical Center in Washington, told Reuters.

Stay tuned.