Pfizer’s Tygacil Linked to Increased Risk of Death
The U.S. Food and Drug Administration is requiring that the Pfizer’s antibacterial drug carry a black box warning label as data has revealed that the drug carries a higher risk of death than alternative treatments.
What is Tygacil?
- Tygacil is an antibacterial drug used to treat complicated skin and digestive infections.
- The drug has also been approved to treat community-acquired bacterial-pneumonia, but not other types such as hospital-acquired pneumonia.
Side effects include:
- Severe stomach pain
- In September, 2010, the FDA updated this list warning that the drug carried an increased risk of death over alternative treatments, though the risk could not be linked to FDA approved use.
- Tygacil was originally approved by the FDA in 2005 and generated $335 million for Pfizer in 2012.
Tygacil to Carry Black Box Warning
- Since 2010, the FDA has analyzed 10 clinical trials in which patients were using Tygacil only for FDA approved uses.
- The FDA was able to determine that Tygacil still carried increased risk of death over other treatments even when off-label uses were removed.
- Pfizer will now be required to include a black box warning label with Tygacil indicated that the drug carries risks of the most serious nature.
- Further, the label advises doctors that Tygacil should only be used in situations where safer options have failed.
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