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...FDA advisory panel last week recommended adding the agency's strongest possible safety warning for Ritalin and other popular attention-deficit drugs. Here's what's behind the buzz...
Slapping a "black box" warning on a prescription drug is not an action that the Food and Drug Administration takes lightly. So when an FDA advisory committee recommended on Thursday that the agency's strongest safety warnings be placed on packages of the massively popular drug Ritalin and similar stimulants used to treat Attention Deficit Hyperactivity Disorder (ADHD) and its less frenetic cousin, ADD, the suggestion made national headlines and generally freaked out patients, parents and more than a few doctors...
...Oddly enough, the panel wasn't meant to consider the issue of drug labeling. Instead, it was exploring whether some rare but frightening instances of sudden death occurring in people taking these drugs warranted further study. There have been 25 such cases reported to the FDA in recent years, though it's uncertain that the drugs caused the deaths. In addition, the panel looked at preliminary data suggesting an increased risk of arrhythmias and strokes associated with these medications. "The main purpose of the meeting was to look at study design to review this," explained Dr. Thomas Laughren, director...
...panel's recommendation also reflects a general concern among some members of the medical community that use of ADHD drugs has spun out of control in the U.S. "No where else in the world are 10% of 10 year-old boys diagnosed and treated for ADD," says FDA panel advisor Curt Furberg, a professor of public health at Wake Forest University, who voted in favor of the warning. "I don't argue that there are some kids who need that treatment, but it's probably overused." Doctors Furberg and Nissen are also concerned about the rising number of adults...
...FDA clearly wasn't expecting such a bomb to go off in a routine meeting, but now the agency must deal with the fallout. A black box warning is unlikely. "We don't feel the risk is well enough established," said Dr. Laughren. But studies of the cardiovascular effects of these drugs are likely to get underway, and, given how many Americans are already taking them, they are probably long overdue. The FDA will also weigh a unanimous recommendation by the panel to make potential risks to the heart more apparent in the patient guides given out by pharmacies. That...