The FDA Requires a Warning on ADHD Drugs
The Food and Drug Administration today announced that manufacturers of Ritalin, Adderall, and other stimulants used to treat attention deficit hyperactivity disorder must provide a consumer-friendly guide along with the prescription that warns about serious side effects associated with the drugs. Twenty-seven children taking the drugs died suddenly from 1992 to 2005 because of previously undetected heart problems, according to the FDA. There have also been reports of strokes and heart attacks in adults. What's more, about 1 in 1,000 users experiences psychiatric effects like hearing voices or seeing hallucinations.
While applauding today's decision, some experts say it was too long in coming. Last fall, the FDA began requiring manufacturers to list the side effects on the package inserts for all 13 ADHD drugs after declining to heed the recommendations of its drug safety advisory committee to issue a stronger warning. But the technical language on the inserts is often difficult even for doctors to decipher. "The medication guides will be written in a language that is more understandable for patients and their families," says Tom Laughren, FDA director of the division of psychiatric products. "We want to remind them that if they do take these medications, it's important to let their doctor know if they develop new symptoms during treatment." Manufacturers will have 30 days to get the new guides into drugstores, he adds.
About 1.5 million adults and 2.5 million children–including 10 percent of 10-year-old boys–currently take a stimulant to help them focus and control impulsive behaviors. The medication guide emphasizes that those with heart conditions, heart defects, or high blood pressure should speak with their doctors before taking the drug and should stop taking the drug if they develop psychiatric symptoms or heart symptoms like palpitations or chest pain.
"The actions taken today by the FDA are the right actions," says Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic and president of the American College of Cardiology, who served on the advisory committee that recommended a strong warning. Nissen testified last week before the House's Subcommittee on Oversight and Investigations, which is looking into the FDA's record on drug safety.