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ADHD drugmakers must tell of risks

Federal officials instruct manufacturers to create pamphlets explaining potential side effects such as hallucination

Feb 23, 2007 | SOUTH FLORIDA SUN-SENTINEL

Federal officials told the makers of Ritalin, Adderall, Strattera and all other drugs for treatment of attention deficit hyperactivity disorder, or ADHD, on Wednesday to come up with new pamphlets to explain the potential risks of the drugs to patients and parents.

The announcement came almost a year after panels of Food and Drug Administration advisers recommended that informational guides be provided to consumers. There are 15 drugs to treat ADHD, including extended-release, patch and chewable versions.

The panels made the recommendation after reviewing reports of young children hearing voices or having hallucinations while on the medications, some reporting they could see snakes or bugs or worms, and there were other reports of heart complications, including sudden death.

An agency review found a slightly increased risk, about one per 1,000 patients for adverse psychiatric reactions. A separate review of reports of serious cardiovascular adverse events found reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

The new patient guides would supplement the information already included on the drugs' labeling and would be given out in booklet or pamphlet form with each prescription.

Dr. Mark Epstein, a specialist in the treatment of ADHD and medical director of the Miami Children's Hospital Dan Marino Center in Weston, Fla., said the concerns first surfaced about two years ago and that he got calls from many parents of his patients who take the drugs.

"Parents are very scared when they hear about a risk for sudden death," Epstein said. But after he explained that the risk is no higher for children on the drugs than for the general population, and that the deaths occurred in patients with known heart problems or a family history of such problems, only one or two parents insisted their children be taken off the drugs, he said.

"When the appropriate diagnosis is made and the medications are prescribed properly, they are exceedingly safe," Epstein said, but he recommended that patients and parents talk with their own doctors if they have concerns.

ADHD affects an estimated 3 percent to 7 percent of school-age children and about 4 percent of adults. The three main symptoms are inattention, hyperactivity and impulsivity.