Last Friday, September 27th, the Food and Drug Administration (FDA) warned that the antibacterial drug Tygacil can increase the risk of death among users. For both intended and unintended uses of the drug, Tygacil can be fatal, as stated by the FDA last week. A product of Pfizer Inc., Tygacil will soon come with a black box warning, the contents of which will indicate that the risks of taking the drug are of the most serious nature.
Tygacil is typically prescribed to treat skin and / or abdominal infections considered to be “complicated.” It is also intended for the treatment of community-acquired bacterial pneumonia. Not suitable for the treatment of diabetic foot infections or hospital-acquired pneumonia, Tygacil will now be used only as an alternative when no other suitable treatments are available.
The FDA’s warning comes after several years of investigations into the fatal side effects connected to the drug. As far back as 2010, the FDA issued a reminder to all physicians warning medical practitioners of the drug’s high risk of death over others used to treat similar and / or identical infections. At the time of the agency’s study, most deaths were found to correspond to the progression of an infection and increased risk of death was primarily seen in those patients who suffered from hospital-acquired pneumonia. In the same year, the FDA issued a notice which updated the “Warnings and Precautions” section of the label to include the risks associated with consumption of the medication.
At least ten trials of patients taking Tygacil have been analyzed by the FDA since 2010, the combination of which yielded results indicating the higher risk of death among patients as compared to patients taking other antibacterial medications. Similar to the agency’s first round of studies, the new sets of patients seemed to experience death from worsening infections or complications from infections. In some cases, an underlying medical condition was also connected to death.
Since it was approved in the United States in 2005, Tygacil has been a large source of revenue for Pfizer Inc. In 2012 alone, the drug generated sales worth $335 million. Pfizer, Inc. is a giant in the drug industry, and this isn’t the first time that the company has been connected to a dangerous product. If you or someone you love were unduly harmed by the use of a defective drug, you can take legal action for compensation. Contact The Senators(Ret.) Firm to learn more.