New Warning Urged On Antidepressants
Alert Would Address Suicidal Tendencies

By Shankar Vedantam
Washington Post Staff Writer
Tuesday, March 23, 2004; Page A03

The Food and Drug Administration urged drugmakers yesterday to put new warning labels on popular antidepressant medications, including Paxil, Zoloft and Luvox, alerting doctors and consumers to watch for suicidal tendencies, hostility and agitation in patients taking the drugs.

The agency's action focuses on 10 antidepressant drugs in all and follows a warning by the British government last year advising physicians not to prescribe most widely used antidepressants to children. Last month, families of American adolescents who killed themselves while taking the medications implored the FDA to take comparable steps, and an expert advisory committee urged greater vigilance in the use of the medications in children with depression.

The agency said it does not know whether the medications -- which include several drugs known as selective serotonin reuptake inhibitors, or SSRIs -- are responsible for reported side effects such as inner restlessness, agitation and suicidal thoughts in some people. Officials said they are drawing greater attention to known cautionary information while a team of outside researchers completes a comprehensive analysis of the possible risks.

Patients taking the drugs who experience behavioral side effects should contact their physicians, said Russell Katz, director of neuropharmacological drug products at the FDA. If the symptoms are new or severe, he added, doctors should consider lowering the dose or stopping the drug.

Yesterday's move by the agency calls for warning-label changes for adults as well as children, and for patients who are depressed as well as those who use the drugs for unrelated problems.

"The advice applies across the board whether the drugs are used for any indication -- psychiatric or not," Katz said.

Critics of the medications called yesterday's move a victory and demanded that the FDA go further. Although Prozac is the only one of this class of drugs that has been specifically approved to treat depression in children, doctors are writing tens of thousands of prescriptions for many of the others, based on their clinical judgment that the drugs are safe and effective.

"Doctors are going to be on the line not to prescribe them as if they were pacifiers," said Vera Hassner Sharav, president of the Alliance for Human Research Protection, a patient advocacy group based in New York.

Many critics complain that a majority of studies of the drugs in children found that the medications did no better than dummy pills in treating depression, but that these studies have been hidden from doctors and the public. The companies say the studies are proprietary.

Sharav and other critics charge that the FDA and the American psychiatric establishment, which has broadly supported the efficacy of the drugs, have been unduly influenced by the pharmaceutical industry. Dozens of lawsuits against the medications have been filed around the country.

Many psychiatrists say the medications save lives and warn that discouraging patients from taking them could lead to greater numbers of suicides. They insist that suicidal tendencies or attempts among patients taking the drugs are the result of underlying disorders, not the medications.

Rates of suicide among adolescents have generally declined as antidepressant use has surged in recent years, said Thomas P. Laughren, FDA team leader for psychiatric drug products. While no one knows whether the two trends are linked, he said at a news conference yesterday, such data framed the context in which the FDA acted.

The drugs affected by yesterday's announcement are Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron.