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May 02, 2008
FDA will require drug developers to test for psychiatric side effects
In continuing coverage from previous editions of Headlines, the Chicago Tribune (4/29, Healy) reported that "a spate of recent announcements from federal health officials suggests a surprising new interpretation of suicidal fantasies and depression: Sometimes sadness, anxiety, and self-destructive thoughts are not symptoms, but side effects," of medications prescribed for smoking cessation, epilepsy, asthma, and influenza.
While the Food and Drug Administration (FDA) "stresses that it has established no direct causal link between these medications and suicidal thoughts," agency "regulators acknowledge that they have had one of two indicators of potential trouble in each case."
In some instances, "a review of a drug's early clinical trials turned up increased rates of suicidal thinking among subjects taking the medicine," or some "patients taking a medication developed symptoms of depression." As a result, "the agency will require developers of many new drugs to test for psychiatric side effects." And, should "early warning systems detect even a hint of psychiatric danger with a medication's use, government officials" will be "inclined to alert first, study later."
Related Links:
- "Thoughts of suicide? It could be the meds you're taking," Melissa Healy, Chicago Tribune, April 29, 2008
- U.S. Food and Drug Administration
Posted by admin at May 2, 2008 01:24 PM