Pfizer Antibacterial Tygacil Required to Have Strongest Warning Per FDA
Pfizer’s intravenous antibacterial drug Tygacil reportedly increases the risk of death from all conditions, whether it is used as directed or for unapproved conditions, according to the US Food and Drug Administration on Friday, September 27th.
The FDA now requires Pfizer to put the strongest warning label possible, advising of Tygacil’s risks, inside a black box and on the drug’s label. Normally, Tygacil is used intravenously to treat community-acquired bacterial pneumonia, as well as complicated skin and abdominal infections. It is not approved to treat hospital-acquired pneumonia, or diabetic foot infections.
The FDA noted that the risk of death was strongest in those with hospital-acquired pneumonia, although they reiterated that Tygacil increases the risk of death regardless of infection.
The warning stems back to as early as 2010, when the FDA issued a reminder warning to doctors and prescribing physicians that Tygacil increases overall risk of death in patients. The agency said at the time that they had analyzed a pool of clinical trial data, and determined that most deaths were related to progression of infection.
The 2010 clinical data came from a study of 10 trials in 5,000 patients using Tygacil, known in its generic form as tigecycline, for FDA-approved applications. Compared to other antibacterial drugs, Tygacil showed a 2.5% increased risk of death. Other antibacterial drugs showed patients had a 1.8% increased chance of death. However, according to the FDA, the increased chance of death had to do with worsening infections and complications from other underlying medical conditions.
Public Citizen, a drug safety watchdog group, said that the FDA has issued the warning at too late a date. The group has been petitioning for the black box warning since 2011.
“The failure of the FDA to require a black box warning years ago is inexcusable,” the group said in a statement.
A spokeswoman for Pfizer, Kimberly Bencker, said that “due to the increase in antibiotic resistance worldwide, Tygacil continues to be an appropriate treatment option for its approved indications.”
“Pfizer encourages health care professionals to review all available information to find an antibiotic therapy that works best for each patient’s clinical situation,” the company said.
Tygacil was originally approved by the FDA for use in the US in 2005.
Pfizer currently faces several lawsuits regarding its statin drug Lipitor, which has reportedly been linked to an increased risk of developing Type 2 diabetes.
The Strom Law Firm Can Help with Defective Drug Cases, Including Tygacil-Related Wrongful Death
Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices, like Tygacil. We represent individuals who have been killed or injured by defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs or medical products such as Tygacil, contact our defective drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your personal injury or wrongful death claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800