July 1, 2005

FDA probes antidepressant safety for adults

By Lisa Richwine

WASHINGTON (Reuters) - U.S. regulators alerted the publicon Friday about a potential link between antidepressant use andsuicidal behavior in adults and urged close monitoring ofpatients taking any of the widely prescribed drugs.

The fresh warning was prompted by recent scientificpublications that suggested a connection, the Food and DrugAdministration said. The FDA had recommended monitoring allantidepressant users in March 2004 for signs of worseningdepression or suicidal behavior, and later concluded that thedrugs did add risk for children and teenagers.

Officials now are trying to determine whether the medicinesmay provoke suicidal thoughts or actions in adults. The reviewis expected to take a year or more.

Millions of Americans use antidepressants, which includePfizer Inc.'s Zoloft, GlaxoSmithKline Plc's Paxil and Eli Lillyand Co.'s Prozac.

Adults taking the drugs should be closely monitored forsigns of worsening depression or an increase in suicidalthinking or behavior, the FDA said. Patients should see adoctor if any of those problems occur.

"Close observation of adults may be especially importantwhen antidepressant medications are started for the first timeor when doses for the specific drugs prescribed have beenchanged," the agency said.

Spokeswomen for Pfizer and GlaxoSmithKline said labels ontheir antidepressants already recommend close monitoring of allpatients for any danger signs.

In addition to the warning for all antidepressants, the FDAsaid it was investigating a higher-than-expected rate ofsuicide attempts among women who took Lilly's drug Cymbalta instudies for stress urinary incontinence, a use that was notapproved.

Trials of Cymbalta for depression and pain from nervedamage in diabetics - the two approved uses - did not show anincrease in suicidal behavior, the FDA said.

A Lilly spokeswoman did not immediately return a callseeking comment.

The fact that depression itself can make patients suicidalhas made it difficult for regulators to determine whetherantidepressant drugs, or the underlying disease, areresponsible for the behavior.

The FDA was criticized for taking months to conclude thatthe drugs did increase risks for youth. Officials said they didnot want to act prematurely and discourage use of medicinesthat can be life-saving by preventing suicide.

The agency told makers in October 2004 to add strongwarnings to the drug labels about the risk in young patients.An earlier advisory in March 2004 had urged close watching ofadults and children for signs of suicidal behavior or worseningdepression.

The FDA said it asked manufacturers to provide informationfrom all trials that compare use of antidepressants to aplacebo in adults.

The review will involve "many hundreds" of clinical trialsthat enrolled thousands of patients, the agency said, addingthat its analysis started before recent published studiesraising the issue.