The U.S. Food and Drug Administration (FDA) is warning the public that the antibiotic drug tigecycline—sold under the brand name Tygacil—might cause life-threatening side effects.
What Is Tygacil and What Is It Prescribed For?
Tygacil is the brand name for the drug tigecycline. Made and sold by Wyeth, a subsidiary of Pfizer, Inc., this prescription antibiotic medication is used to treat skin infections, intra-abdominal infections, and community-acquired bacterial pneumonia. The FDA approved Tygacil in June 2005, and doctors can prescribe it in the form of an intravenous injection. The drug kills bacteria by preventing protein formation inside their cells.
Tygacil Might Cause Deadly Side Effects
In September 2010, the FDA issued a drug safety communication warning the public that using Tygacil for unapproved uses, especially diabetic foot infection and ventilator-assisted pneumonia (a form of hospital-acquired pneumonia), could increase the risk of death in users. The FDA conducted a meta-analysis of 13 Tygacil drug trials and found that 4.0 percent of Tygacil users died from any cause compared to 3.0 percent of users of similar antibiotics. The study’s findings were not statistically significant, but because the mortality rate was greater for every type of infection, the FDA issued the Tygacil warning.
Two years later in September 2013, the FDA issued a second Tygacil warning. This time, the agency determined that the risk of death in Tygacil users was higher than for users of other antibiotics even for conditions for which Tygacil is approved. As a result, the FDA mandated a label-change to Tygacil to include a “black box” warning—the most serious kind—advising the public of the danger. Now, health care professionals should only prescribe Tygacil treatment in situations for which “alternative treatments aren’t suitable.”
The FDA based its second drug safety communication on an analysis of 10 more clinical trials, including ones that occurred after the drug was approved in 2005. The agency found that for approved uses, 2.5 percent of Tygacil users died during treatment as opposed to 1.8 percent of users of other antibiotics.
The general causes of Tygacil-related deaths were:
- Worsening infections
- Complications of infection
- Other underlying medical conditions
Anyone who took Tygacil and died subsequently might be able to show that the drug’s manufacturer was responsible.
RLG’s Tygacil Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Tygacil lawsuit on your behalf if necessary. RLG will also keep you up to date on any Tygacil class action lawsuits, additional FDA Tygacil warnings, and Tygacil FDA recall announcements. If you or a loved one took Tygacil, and you believe it caused a fatal complication, contact RLG today.