News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation.
Lawyers for consumers and injured people.(No advice on this blog, though)
Friday, November 01, 2013
FDA Warning that Pfizer’s Tygacil Increases Risk of Death
News from the FDA on this product:
ISSUE: FDA notified health professionals and their medical care organizations of a new Boxed Warning describing an increased risk of death when intravenous Tygacil is used for FDA-approved uses as well as for non-approved uses. These changes to the Tygacil Prescribing Information are based on an additional analysis that was conducted for FDA-approved uses after FDA issuing a Drug Safety Communication about this safety concern in September 2010.
This analysis showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively. The adjusted risk difference for death was 0.6% with corresponding 95% confidence interval (0.0%, 1.2%). In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.
BACKGROUND: Tygacil is FDA-approved to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP).
RECOMMENDATION: Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable.