FDA wants clear warnings on ADHD drugs

Feb 22 2007

The Food and Drug Administration (FDA) in the United States has ordered drugmakers to alert patients to the possible cardiovascular and psychiatric risks attached to drugs used to treat attention deficit hyperactivity disorder (ADHD).

The FDA says patient-friendly guides need to be developed and handed out with the medications which clearly explain the risks.

The drugs already carry warnings on their labels but the FDA says extra steps are needed to alert patients about the potential risks.

However Dr. Tom Laughren, the head of the FDA's division of psychiatry products, says ADHD is an important ailment that benefits from treatment from this class of medications and they are generally considered to be quite safe.

Many drug companies produce ADHD drugs and most have promised to work with the FDA to produce the patient information.

Sufferers with ADHD find it difficult to pay attention and the condition can cause hyperactivity and impulsiveness.

People with ADHD may have low self-esteem and too often experience difficulty in school and have trouble relating to family and peers.

The risk of heart and psychiatric trouble in patients taking ADHD medications is not a new one; in 2006 concerns were raised over the risks associated with the drugs after reports of sudden death, heart attack and stroke in patients with underlying heart problems.

Another FDA review found that about one in 1,000 patients experienced drug-related psychiatric issues, such as hearing voices, becoming suspicious for no reason, or becoming manic.

The FDA came in for harsh criticism last year when, with no preamble it asked manufacturers to include the warning on their labels.

Some critics have challenged the agency for taking too long to notify the public about the risks, while others have said the warnings could lead some patients who might benefit from the drugs, to stop taking them.

Laughren says the agency wants patients to be given easily understood information that will encourage them to provide details about past heart or mental concerns before taking the drugs.

The guidelines, he says would also encourage them to report side effects.

According to the FDA, ADHD affects 3 to 7 percent of school-aged children and about 4 percent of adults.

An estimated 2.5 million U.S. children and 1.5 million adults now take medications for the treatment of ADHD.

Officials hope that the guides, which are given to patients at the time the drug is dispensed, will alert doctors and patients to the importance of taking a careful medical history, doing a physical exam and carefully monitoring patients for symptoms that may indicate a problem.

The medications affected by the action include Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate CD, Methylin, Ritalin, Ritalin SR, Ritalin LA and Strattera.

Companies have 30 days to comply with the FDA's request. A draft of the guide is posted on the FDA's Web site.