FDA Approves Black Box Warning Language for Certain Antidepressants
FDA officials on Thursday said they have approved the final wording for black box warning labels to be placed on certain antidepressants, after a government panel in September 2004 recommended that the warnings be added, the Newark Star-Ledger reports (Silverman, Newark Star-Ledger, 1/14). FDA in October 2004 ordered pharmaceutical companies that manufacture antidepressants to add black box warnings to drug packaging advising consumers that the drugs could cause suicidal thoughts and actions in people younger than age 18. The warnings consist of a black section with white writing that appears at the top of drug inserts distributed to physicians and patients and are the strongest warnings that federal regulators can impose before banning a medication.
An FDA advisory panel on Sept. 14, 2004 voted 15-8 to recommend that all antidepressants carry such a warning. On Sept. 13, 2004 FDA officials said that an analysis of 15 clinical trials -- some of which were not made public for years -- found that there is a "consistent link" between the use of any kind of antidepressant and suicidal tendencies in children. The analysis found that antidepressants appeared to raise the risk of suicidal thoughts or actions in children 2% to 3% of the time. FDA also directed the manufacturers to print and distribute medication guides with every antidepressant prescription (California Healthline, 10/18/04).
The warning will be added to several "widely prescribed drugs," such as Effexor, Zoloft, Paxil and Prozac, the Star-Ledger reports. The labeling must be placed on manufacturers' Web sites within two weeks and on all products within 30 days, according to an FDA letter to drug manufacturers. A medication guide should be made available by Jan. 31.
Wyeth spokesperson Doug Petkus said the company will "move as quickly as possible" to add the warning; however, he did not give a specific date.
Vera Sharav of the Alliance for Human Research Protection said, "It shouldn't take this long to issue a ... warning involving children."
FDA officials said the process was not unusually long, and they cited the need to conduct reviews and discussions with agency officials and manufacturers (Newark Star-Ledger, 1/14).