Divided FDA Panel Calls for Warning Label

The special government panel voted to require "black box" labels for all under-investigation medications containing methylphenidate.

Saturday April 1st - 12:00am

An FDA advisory panel voted 8-7 last month to recommend that medications containing the stimulant methylphenidate be required to carry a "black box" warning label, informing users of an increased risk of cardiac arrest and other serious side effects. Ritalin, Methylin, Metadate, and Concerta all contain methylphenidate.

The panel made its recommendation after an FDA review of data collected between 1999 and 2003 revealed 25 cases of sudden death and 54 incidents of severe cardiovascular problems among children and adults taking methylphenidate. The FDA review noted that some of these patients had preexisting heart disease or high blood pressure, adding that the drugs did not necessarily cause the health problems.

Larry Silver, M.D., clinical professor of psychiatry at Georgetown University Medical School in Washington, D.C., and chairman of ADDitude's scientific advisory board, believes that it is too early to conclude that these medications caused the deaths.

"We are talking about 54 cases over a four-year period, and about two million children taking these medications each month," he said. "Is this higher than the normal expected rate of cardiac deaths?"

Dr. Silver said that parents should wait for the FDA's final action before making any changes in a child's medication regimen. "My advice is to wait for the final assessments. The final recommendation may not be as severe as that proposed by this advisory panel."

The FDA is not required to follow the panel's advice, and it will hear from other advisory committees before making a final decision.

Steven Nissen, M.D., a Cleveland Clinic cardiologist, is the panel member who proposed the warning label recommendation. He said he did so, in part, out of concern that neither doctors nor patients are paying sufficient attention to the risks posed by methylphenidate.

"This is a disease that is almost certainly overdiagnosed," said Dr. Nissen. "It's pretty clear there has been an absence of respect for the risks and benefits" of prescribing stimulant-based drugs. "By pointing out the safety issue, you force people to think before they prescribe," he said. "That's an appropriate regulatory action."

Dr. Nissen said he was particularly concerned about the dramatic increase in the use of methylphenidate by older adults, whose risk for heart problems is already elevated.

Similar reports of sudden deaths among children led Health Canada, the Canadian drug regulatory agency, to ban Adderall XR last year. (The ban was reversed six months later.) Following Health Canada's ban, the FDA issued a health advisory on Adderall XR, which contains a different stimulant, but did not restrict sales.

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