The Food and Drug Administration said antidepressants appear to increase the risk of suicidal thinking in young adults but that in older adults the risk declines.
The FDA reviewed data from 372 clinical studies involving 11 antidepressants including GlaxoSmithKline PLC's Paxil, Pfizer Inc.'s Zoloft and Eli Lilly & Co.'s Prozac. The studies involved almost 100,000 patients.
The FDA requested the data from drug makers last year in the wake of evidence antidepressants increased suicidal thoughts and behavior in children and adolescents to see if the same risk carried through to adulthood. The drugs carry a "black box" warning about the increased risk in children and adolescents.
The FDA review of the data, which date back to 1985, suggested a "differential risk of antidepressant-induced suicidality across the age spectrum." The agency said in documents posted to its Web site the risk was greater at the younger end of the spectrum and that it declined with age with a likely "protective" effect in adults age 65 and older.
The FDA review was posted ahead of a Dec. 13 advisory committee meeting scheduled to discuss the data and whether updated drug labels are needed to discuss the finding on suicidal thinking in adults. An FDA spokeswoman said the agency planned to update the labels but will seek the panel's input before the labels are changed.
This year, GlaxoSmithKline released an analysis of studies that involved 8,958 patients on Paxil and 5,953 on placebo, or a fake pill. Among the findings was a small but statistically significant increase in suicidal thoughts among young adults patients diagnosed with a major depressive disorder. The company updated Paxil's label warning doctors about the possibility of an increase in suicidal behavior in young adults.
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