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Pharmaceutical Products and Suicide Risks
Last November, after it received reports of suicidal ideation and violent behavior in patients taking Chantix (varenicline) a prescription medication to help smokers stop smoking, the FDA issued an 'Early Communication' about the drug. Early Communications are issued when the FDA receives negative information about a medication that may or may not be a cause for concern, and further study is needed. In the case of Chantix, the FDA in February followed up its Early Communication with a more forceful Public Health Advisory and a request that Pfizer, the drug's maker, start placing new warnings about suicide risk in the drugs 'Warnings and Precautions' section. According to the FDA, the request for a label change was prompted by the agency's review of adverse event reports in which it appeared 'increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.'
This is just one of the many drugs that are now being studied again, despite already having been approved for human use, for the possibility that they may cause users to commit suicide or become violent toward others. While inquiry into the psychological effects that antidepressant, acne-control and other drugs might have on patients is not new, the current trend toward focusing a light on such problems is creating new headaches for drug developers and manufacturers, not only in the extra expenses required for more in-depth studies, but also in the number of consumers emboldened to file suits by the constant stream of headlines announcing that yet another drug may cause suicidal ideation.
The question is, does the increased scrutiny on drug products for evidence that they cause suicidal thoughts mean that suits seeking damages for such thoughts in drug consumers have a better chance at success? The fact is, problems of proof are ever present in these cases, and the state of the law in many jurisdictions is not favorable for plaintiffs. In addition, the U.S. Supreme Court stands poised to decide a case that could effectively squelch most state-law-based failure-to-warn and similar suits against pharmaceuticals manufacturers.
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