Product News and Recalls

FDA Warns of Strong Risk of Death with Pfizer’s Drug Tygacil

The antibacterial drug Tygacil carries a higher risk of death than other drugs of its kind, an article by Reuters reports.

The U.S. Food and Drug Administration issued a safety announcement on September 27, 2013 approving a new Black Box Warning, the strongest warning that can be given to a drug, as well as updated Warnings and Precautions and Adverse Reactions portions of the drug label.

The FDA states on their website that “Tygacil is FDA-approved to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP). Tygacil is not indicated for treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia.”

In late 2010, the FDA warned physicians to only use Tygacil if alternative drugs were not seen fit. At the time, the agency analyzed one clinical trial and found most deaths to be related to the infection itself.

Reuters reports that since issuing the first notice, “the FDA said it has analyzed data from 10 trials of patients who took the drug only for FDA-approved uses. This analysis also showed a higher risk of death compared to other antibacterial drugs.”

First approved in 2005, Tygacil made $335 million in 2012 for the pharmaceutical giant.

You should consult a medical professional before altering your medical care.