FDA Seeks Second Opinion

A month after advisers told the government some attention deficit hyperactivity disorder drugs should bear stronger warnings of cardiovascular risks, officials are asking a second panel whether to add warnings about psychosis or mania.

Small numbers of reports of adverse psychiatric events, including hallucinations, in children are associated with all of the increasingly popular drugs used to treat ADHD, according to recently released Food and Drug Administration documents.

The FDA is asking its pediatric advisory committee to review those reports and then recommend how to communicate the potential risks to doctors and parents. It's asking the same about a report of increased risks of heart attack, stroke and hypertension associated with some ADHD drugs.

The panel was to meet Wednesday.

Last month, the FDA's Drug Safety and Risk Management advisory committee voted to recommend adding "black-box" warnings to stimulants used to treat ADHD, alerting doctors, patients and parents of the uncertainty regarding the risk the drugs may pose to the cardiovascular system. The warnings are the most serious that prescription drugs may bear.

The FDA is not required to follow the recommendations of its advisory committees, but usually does.

The latest reviews show that psychosis or mania can occur in some juvenile patients at normal doses of any ADHD drug. The reviews included roughly 90 studies of the drugs as well as reports from doctors, parents and others.

The ADHD drugs include Ritalin, manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall, made by Shire Pharmaceuticals Inc.; and Strattera, produced by Eli Lilly and Co.

FDA officials say patients and doctors should be aware that the small number of psychiatric events could represent side effects of the drugs, although they cannot point to a definitive link. However, they noted a "complete absence" of similar reports in children treated with dummy pills during dozens of clinical trials of the drugs. In many children, the events ceased once they stopped taking the drugs — and resumed if they restarted.

McNeil Consumer & Specialty Pharmaceuticals said in briefing documents that it is customary to weigh the "therapeutic benefits and potential risks" of treatment and warned of the negative effects of leaving ADHD untreated. The unit of Johnson & Johnson makes Concerta, a long-acting form of methylphenidate, the drug in Ritalin.

In the United States, nearly 3.3 million people age 19 and younger used an ADHD drug in 2005, according to Medco Health Solutions Inc., a prescription drug benefit program manager.