The Food and Drug Administration is ordering makers of drugs for attention deficit hyperactivity disorder to alert patients that the medications could pose cardiovascular and psychiatric risks.
The agency didn't identify any specific product or company, but its ruling covers products from companies such as
Johnson & Johnson
After analyzing reports of "serious cardiovascular adverse events" among patients who took normal doses of drugs for ADHD, the FDA decided to act. The review revealed "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 FDA said another examination of ADHD drugs showed a "slight risk" -- one case per 1,000 patients -- of psychiatric side effects. The problems included hearing voices, becoming suspicious for no reason and becoming manic. The side effects showed up in people who hadn't experienced psychiatric problems in the past.
"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
The agency says ADHD affects 3% to 7% of children and 4% of adults who exhibit inattention, hyperactivity and impulsive behavior.
Wednesday's announcement requires the creation of medication guides, the inserts that come with drugs so pharmacists can give them out. The guides reflect changes made to ADHD drugs' labels last year, said Dr. Tom Laughren, director of the FDA's division of psychiatry products.
Speaking to journalists during a conference call, Laughren said the "more prominent" warnings about cardiovascular and psychiatric issues evolved from hearings held by two FDA advisory committees early in 2006.
The hearings created a stir when
one panel said most ADHD drugs should carry a "black box" warning for cardiovascular risk. A black box is the FDA's strongest alert. The vote was 8-7 with one abstention. However, the other panel said only that the labels should clearly identify the possibility of cardiovascular and psychiatric problems.
Some ADHD drugs already have black box warnings. The label for Shire's Adderall XR, for example, warns about the potential for addiction and abuse because the drug is an amphetamine. Lilly's Strattera has a black box about the risk of suicidal thoughts for some teens and children.
In addition to Adderall XR and Strattera, drugs covered by the FDA's warning include Concerta, Daytrana, Focalin, Methylin and Ritalin.
Separately, the FDA on Wednesday asked
to add a black box warning to Xolair because the asthma drug may cause anaphylaxis. This side effect, which can be life-threatening, can result in breathing difficulties, chest-tightening, fainting and swelling of the mouth and throat.
Also, the FDA recently reported that
is alerting doctors that women who take the diabetes drugs Avandia, Avandmet and Avandaryl have a higher risk of fractures of the upper arm, foot or hand than women who take any of several other drugs.
Citing a recently published clinical trial, the company said there was no extra risk for men. "Further evaluation of these observations is ongoing," Glaxo says.