Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

Medical Malpractice Law & StrategyLJN NewslettersNewsSections

Pharmaceutical Products and Suicide Risks

By Janice G. Inman
May 29, 2008

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.

This premium content is locked for Entertainment Law & Finance subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
New York's Latest Cybersecurity Commitment Image

On Aug. 9, 2023, Gov. Kathy Hochul introduced New York's inaugural comprehensive cybersecurity strategy. In sum, the plan aims to update government networks, bolster county-level digital defenses, and regulate critical infrastructure.

The Bankruptcy Hotline Image

Recent cases of importance to your practice.

The DOJ's Corporate Enforcement Policy: One Year Later Image

The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.

How AI Has Affected PR Image

When we consider how the use of AI affects legal PR and communications, we have to look at it as an industrywide global phenomenon. A recent online conference provided an overview of the latest AI trends in public relations, and specifically, the impact of AI on communications. Here are some of the key points and takeaways from several of the speakers, who provided current best practices, tips, concerns and case studies.

CLE Shouldn't Be the Only Mandatory Training for Attorneys Image

Each stage of an attorney's career offers opportunities for a curriculum that addresses both the individual's and the firm's need to drive success.