Tough Warnings Ordered for All Antidepressants

FDA says 'black-box' warning on labels is response to youth suicide potential

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HealthDay Reporter

FRIDAY, Oct. 15, 2004 (HealthDayNews) -- All antidepressants must carry a "black box" warning, the government's toughest safety alert, saying the drugs have been linked to increased suicidal thoughts and behavior in children, U.S. health officials announced Friday.

"The strategy is designed to provide important new information to parents, families, and health-care providers in ways to protect depressed children from the increased risk of suicidal thoughts and actions associated with antidepressant drugs," Dr. Lester Crawford, acting commissioner of the U.S. Food and Drug Administration, said at a news conference in Washington, D.C.

The FDA decision follows the recommendations of two of its advisory committees. The panels last month presided over emotional hearings during which supporters and opponents of the drugs clashed over their use in children and teenagers.

Last year, British authorities declared that all antidepressants except Prozac should not be used in children or adolescents. That decision set off a furor in the United States, so earlier this year the FDA asked drug manufacturers to change the labeling of 10 drugs to reflect the need to monitor young patients more closely.

In August, the FDA released information on an analysis by a senior FDA epidemiologist finding that, overall, children using antidepressants were 1.8 times more likely to have suicidal tendencies than depressed children taking placebos. The following month, one of the two FDA advisory panels recommended adding a black box warning.

Prozac is the only medication approved to treat depression in children and adolescents. Other drugs are used, however, based on evidence of their effectiveness from clinical trials.

In announcing the new actions, FDA officials stressed that many of these drugs do have known benefits in treating depression in children.

"FDA's repeated analyses confirmed that the use of these drugs causes a significant increase in suicidal ideas and behavior in children and adolescents, but we continue to believe that they provide significant benefit when used appropriately," Crawford said. "The new warning label does not prohibit their use in children and adolescents. Rather, it warns of the risks and the need to balance these with clinical need."

In all, the FDA is mandating that four separate but related actions be taken.

The first is the issuance of a "public health advisory" about the increased risk of suicidal thoughts or actions among children taking the drugs.

Second, the FDA is directing all manufacturers of all antidepressant medications to add the black box warning, addressing the potential risk of suicidal thoughts or actions in pediatric patients. The black box warning, which is primarily directed to health-care professionals, will advise close monitoring of patients, including any signs of suicidality or unusual changes in behavior.

"In other words, these drugs should not be used casually," Dr. Sandra Kweder, acting director of the FDA's Center for Drug Evaluation and Research, said at the news conference.

"We expect that these label changes will be implemented almost immediately," Kweder continued. "Any delay in seeing them on the shelves will be due to printing kinds of issue and actually shipping. Within the next month or two, people should start to see them regularly in the pharmacy."

Third, drug companies will be required to distribute user-friendly Patient Medication Guides (MedGuides) to all patients getting a prescription or a refill of an antidepressant. These guides will spell out in easily understood terms the potential risks involved with using the drugs. They'll also detail changes in a patient's behavior that might signal potential problems. "We are near finalizing the language of the MedGuide," Kweder said.

Finally, the FDA said it will be working with manufacturers to make drugs available in "unit of use" packaging, which means they will be sealed and labeled for one course of treatment. This will help ensure that all prescriptions also come with a MedGuide.

"If you really want to make sure that the patient gets appropriate information, one would think the best way would be to make sure it is in the original box that is not disturbed, and goes from the manufacturer through the pharmacy straight to the patient," Kweder said. "This means you won't have to figure out how to get medication guides to the patient when a large jar is being used to fill up smaller bottles, and the MedGuide sits somewhere on another shelf and is easily forgotten."

The new warnings will be carried by all antidepressants, including Anafranil, Aventyl, Celexa, Cymbalta, Desyrel, Effexor, Elavil, Lexapro, Ludiomil, Luvox, Marplan, Nardil, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron, Sarafem, Serzone, Sinequan, Surmontil, Symbyax, Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft, and Zyban.

More information

For more on antidepressant use in children, teens and adults, visit the FDA.

SOURCES: Oct. 15, 2004, news conference with Lester M. Crawford, D.V.M., Ph.D., acting commissioner, U.S. Food and Drug Administration, and Sandra Kweder, M.D., acting director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

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