Originally published February 26 2006
FDA panel recommends black box warning for ADHD drugs
by Mike Adams, the Health Ranger, NaturalNews Editor
Overuse and side effects are two reasons an FDA advisory panel recommended that ADHD drugs carry a "black box" warning to alert consumers to their potential risks.
Several drugs widely used to treat attention-deficit hyperactivity disorder should carry a prominent "black box" warning because of reports that they may have caused sudden deaths or serious complications, a federal expert advisory panel recommended yesterday.
The proposal to require a warning on medications such as Adderall and Ritalin took the Food and Drug Administration, pharmaceutical companies and advocates by surprise.
The panel voted 8 to 7 to call for the labeling change after reviewing reports of several dozen patients who suffered cardiac arrest, toxic reactions or sudden death while using the medications.
Members of the board said the recommendation was driven as much by worries that the drugs are being overused in the United States as by the possible side effects: About 10 percent of 10-year-old American boys are taking such medications, and there have been recent sharp increases in the number of adults taking them.
"On the surface, it is hard to believe," said Curt Furberg, professor of public health sciences at North Carolina's Wake Forest University Medical School, who voted for the black-box warning.
FDA officials, who convened the panel to discuss how best to assess the risks of the drugs, said they would weigh the recommendation.
How the agency will act in this case is especially uncertain because the recommendation clearly went further than the agency had thought necessary.
Black-box warnings are intended to alert physicians and patients that a drug may carry significant risks; fewer than 10 percent of prescription drugs carry them, according to a 2002 study.
Cardiologist Steven Nissen of the Cleveland Clinic, who was one of the committee members who pushed for the warning label, said the growing use of ADHD drugs in adults is a serious concern because the risk of heart attack rises among adults older than 50.
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