Wall Street Journal Examines FDA Actions on Warnings About Link Between Antidepressants, Suicidal Behavior
As a House Energy and Commerce subcommittee prepares to hold a hearing Thursday on antidepressants and disclosure issues, the Wall Street Journal on Wednesday examined FDA's actions in regard to warnings that Wyeth's Effexor may be linked to suicidal thoughts in children who take the antidepressant. Wyeth in August 2003 added a warning to Effexor's label to that effect, but FDA requested that the drug maker remove the warning and replace it with a more general caution included on all major antidepressants urging physicians to monitor patients of all ages who take the drugs.
Although a new FDA analysis of antidepressant clinical trials supports Wyeth's original conclusion, FDA officials said they originally requested that the warning be removed because, at the time, they felt there was a "discrepancy" between the warning and FDA's position that no causal tie had been confirmed between antidepressants and suicidal tendencies. According to the Journal, prescription drug labels "are supposed to represent the judgment of FDA scientists, as well as the companies." FDA is sometimes "reluctant" to allow safety warnings if they are unproven because "such cautions are cited by companies as a defense in lawsuits brought by patients' attorneys," the Journal reports.
FDA's actions on antidepressant labeling have "drawn the attention of Congress" largely because the agency in February would not allow Dr. Andrew Mosholder, who works for FDA, to publicly disclose his conclusion that there was evidence of a possible link between antidepressants and suicidal tendencies in children. FDA officials said they allowed Mosholder to release his data but not his analysis because they "considered the findings premature" and were planning a new analysis, which was released Aug. 20, the Journal reports.
The new analysis found an increase in suicidal thoughts among children who took antidepressants -- particularly those who took Effexor. FDA officials said they will address plans to revise the antidepressant warning labels to reflect the analysis when an advisory committee convenes next week (Wilde Mathews, Wall Street Journal, 9/8).