Stronger Warnings Recommended for ADHD Drugs

Concerned about the risk of sudden death or serious injury associated with Ritalin and other stimulants used to treat attention deficit hyperactivity disorder, a federal advisory panel says the drugs should carry the most serious type of warning label.

The surprise recommendation has caught the Food and Drug Administration off guard. The regulatory agency isn't obliged to follow the advice of its outside panels of experts but it generally does.

The FDA also may undertake short-term studies into the effect of the drugs on blood pressure, heart rate and the heart muscle itself, said Dr. Peter Gross, chairman of the FDA's Drug Safety and Risk Management advisory committee, which eventually did outline its thoughts on how to study the drugs.

When asked why he and his fellow advisers approved, albeit narrowly, a recommendation they hadn't been asked to consider, Gross said: "No. 1, because of the seriousness of the side effects — the sudden deaths. No. 2, there is a sense maybe the diagnosis of ADHD is being applied where it shouldn't be applied."

An FDA review of its own databases found reports of 25 deaths in children and adults treated with the increasingly popular medicines. The deaths occurred between 1999 and 2003. The review also detailed 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia.

Doctors prescribe the drugs to about 2 million children and 1 million adults a month. Among 12-year-old boys, 9.3 percent take ADHD drugs, according to a federal survey.

There are many people who genuinely need these drugs to function. However, sometimes they are used as an easy way out to change minor behavioral issues. These are serious drugs. Get opinions from multiple doctors, see specialists, do research, etc. before making the decision to go with stimulants such as these.