Defective Drug Under Scrutiny

Drug Under Scrutiny. A hyperactivity drug linked last year to deaths, strokes and heart attacks in dozens of patients is expected to face new scrutiny next week when a government advisory committee considers how to study the safety of such medications.

A Food and Drug Administration advisory committee will meet Feb. 9 and 10 to discuss life-threatening side effects linked to drugs that treat attention deficit hyperactivity disorder (ADHD). Adderall, an ADHD drug made by Shire Plc in England, is expected to be on the agenda.

In 2005, Canada withdrew Adderall XR, an extended release capsule, from the market after it was associated with 20 deaths – 14 in children – and a dozen strokes. The deaths occurred in the United States between 1999 and 2003. Canada later allowed Adderall back on the market.

The FDA did not remove Adderall from drugstores here. However, before the Canadian action, the FDA had required Shire to change its U.S. label for Adderall to include a warning about sudden deaths in children with cardiac abnormalities.

Dr. Peter Gross, chairman of the FDA’s Drug Safety and Risk Management Advisory Committee said Tuesday that the panel will contemplate methods for studying the risks posed by ADHD drugs like Adderall while continuing to allow doctors to prescribe them. Gross said Adderall has not come before the committee in the past.

A risk management plan and the FDA advises us later on what was done with the risk management plan

Gross said the committee usually suggests “a risk management plan and the FDA advises us later on what was done with the risk management plan.”

In 2005, the FDA also said it had logged seven sudden deaths in children taking two other ADHD drugs, Concerta, marketed by Johnson & Johnson, and Ritalin, made by Switzerland’s Novartis. An FDA announcement about next week’s meeting did not specify which ADHD drugs will be discussed.

Arthur Levin, another member of the FDA advisory committee and director of the Manhattan-based Center for Medical Consumers, said of Adderall: “It appears as if there’s reason for concern but how strong the evidence is is not clear. Obviously, there’s not convincing data one way or the other.”

Shire spokeswoman Heidi Wunder said the drug company will send representatives to attend the public FDA meeting in Gaithersburg, Md., but that they are not scheduled to speak.

FDA spokeswoman Alice Cohen provided no details except to say that the meeting would address “scientific issues.”

The FDA also is expected to update the committee on steps taken to monitor the safety of Accutane, the acne drug, and Cox-2 inhibitors that treat pain resulting from conditions like arthritis or bursitis.

Another FDA panel, the Pediatric Advisory Committee, has scheduled a March 22 meeting to consider side effects connected to Adderall and several other ADHD drugs used by children.

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