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
Bankruptcy Sales: Finding a Diamond In the Rough Image

There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.

Judge Rules Shaquille O'Neal Will Face Securities Lawsuit for Promotion, Sale of NFTs Image

A federal district court in Miami, FL, has ruled that former National Basketball Association star Shaquille O'Neal will have to face a lawsuit over his promotion of unregistered securities in the form of cryptocurrency tokens and that he was a "seller" of these unregistered securities.

Why So Many Great Lawyers Stink at Business Development and What Law Firms Are Doing About It Image

Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?

Blockchain Domains: New Developments for Brand Owners Image

Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.

Supreme Court Rules Rejection of Trademark License Does Not Rescind Rights of Licensee Image

Mission Product Holdings, Inc. v. Tempnology, LLC The question is whether a debtor's rejection of its agreement granting a license "terminates rights of the licensee that would survive the licensor's breach under applicable nonbankruptcy law."