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FDA Approves Antidepressant Warning Language

Jan 14, 2005 | Star Ledger

In a long-awaited move, the Food and Drug Administration has approved the language for so-called black-box warnings on antidepressants, an agency spokeswoman said late yesterday.

The action comes four months after a government panel determined the medicines were linked to suicide in youngsters. As a result, the panel recommended drug makers add the warnings in order to alert doctors to the serious side effects.

The recommendation followed 18 months of controversy over the medicines. The episode cast a harsh spotlight on the pharmaceutical industry after it became known that some drug makers failed to disclose links between their antidepressants and suicide.

A black-box warning is the most severe warning that can be issued about a prescription drug. The information is prominently placed on package inserts and in physician reference manuals that are read by doctors nationwide.

The warning will be added to several widely prescribed drugs, including Effexor, Zoloft, Paxil and Prozac. Only Prozac was approved for children, but doctors are free to prescribe any medication for patients, which explained widespread usage of many pills.

In a letter to drug makers, the FDA wrote that final labeling should be on company Web sites within two weeks and on all products within 30 days, according to the Pink Sheet, an industry publication. A medication guide is also supposed to be available by Jan. 31.

Doug Petkus, a spokesman for Wyeth, said the Madison-based drug maker, which sells Effexor, will "move as quickly as possible" to add the black-box warnings, although he couldn't provide a specific date.

Last month, some consumer advocates began complaining the FDA was taking too long to enforce the labeling change. They worried some doctors may not change prescribing habits until warnings were issued.

FDA officials said the lengthy process was not unusual, given the need for time-consuming reviews and discussions between agency officials and drug makers. Last month, they said the black-box warning should be in place by late January.

But yesterday, one advocate said the black-box warning was long overdue and continued to criticize the FDA for not acting sooner.

"It shouldn't take this long to issue a warning involving children," Vera Sharav of the Alliance of Human Research Protection said.

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