Warnings required on antidepressants for youths

Suicide links in youths prompt action by FDA

October 16, 2004|By Julie Bell | Julie Bell,SUN STAFF

The Food and Drug Administration issued a public health advisory yesterday and opened a campaign to warn patients, families and doctors that antidepressants can increase the risk of suicidal thoughts in children and adolescents.

The moves, after months of controversy, include a requirement that manufacturers print a "black-box" warning - the FDA's strongest - at the top of the professional labels shipped with the drugs to doctors and pharmacists.

The FDA also is requiring pharmacists to dispense all 32 antidepressants to patients with pamphlets that describe, in simple language approved by the FDA, the increased but relatively infrequent danger associated with the drugs. The pamphlets also will advise families to closely monitor patients who take the medicine.

"We expect that these label changes will be implemented almost immediately," Dr. Sandra Kweder, acting director of the FDA's office of new drugs in the Center for Drug Evaluation and Research, said at a Washington news conference.

She said the FDA expects to develop final language for the medication guide over the next few weeks. Manufacturers will be responsible for working with pharmacies to ensure that the guide is dispensed with the medicine to patients.

To ensure that consumers get the message, the FDA said, it is working with manufacturers to package the medications in containers that hold only enough pills for a single course of treatment, rather than in bulk to be parceled out by pharmacists.

The individual packaging will allow manufacturers to include the medication guides in the patient's box, rather than relying on pharmacists to remember it.

Consumer advocates welcomed the moves.

"We're very pleased," said pharmacist Larry Sasich, a research analyst with Public Citizen Health Research Group. He noted that "reminder" ads are prohibited for drugs that have black-box warnings. Reminder ads generally urge patients to "Ask your doctor" about a particular drug, but provide no specific information.

All print advertisements for antidepressants must now include the black-box warning, and in-depth broadcast ads will have to include a voice-over version of the warning.

In its action, the FDA chose to avoid distinctions that could penalize newer drugs over old ones or cause sales of a particular brand to decline.

A recent FDA analysis found that children on antidepressants were twice as likely as those on dummy pills to have suicidal thoughts or exhibit suicidal behaviors.

The review of 24 trials involving more than 4,400 patients found the average risk of suicidal thoughts or behavior was 4 percent for children on a drug and 2 percent for others.

The analysis also found that the risk was greatest in the first few months of treatment.

FDA officials said yesterday that they are continuing to study the risk of suicidal behavior in adults on the same drugs.

Only Prozac, generically known as fluoxetine, is approved to treat major depression in children. But doctors may prescribe to children any drug approved for adults, and they frequently do so with other antidepressants.

Yesterday's actions were among the strongest the FDA can take, short of removing the drugs from the market.

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