Federal drug regulators have placed a new black box warning on the IV antibiotic Tygacil, alerting doctors and patients about an increased risk of death associated with the drug.  

On September 27, the FDA announced that it was requiring stronger warnings about the potential side effects Tygacil. The agency previously issued a drug safety communication in 2010, warning about the increased risk of death with Tygacil, but the new boxed warning is the strongest that the FDA can place on a prescription medication.

According to the agency, the label warning changes came after additional analysis conducted since the September 2010 warning. The label update was issued nearly two years after the consumer watchdog group Public Citizen petitioned the FDA to strengthen warnings about the Tygacil death risk, and the agency has drawn criticism for the delay in requiring the black box warning.

Tygacil Side Effects

Concerns about Tygacil, an antibiotic given intravenously, were raised after data suggested an increased risk of death. A later analysis of clinical trials showed a 0.7% increased mortality rate among Tygacil users and a 2.9% increase in non-cure rates.

In October 2011, Public Citizen filed a petition with the FDA indicating that its own data showed that there would be one excess death for every 143 patients treated with Tygacil, and one “non-cure” for every 34 patients treated. The prominent consumer watchdog updated the Tygacil black box petition in June 2012. after data from the clinical trial became available.

The FDA is now advising that Tygacil be used as a drug of last resort, only given to patients where alternative treatments are not suitable.

“It’s troubling that the agency took so long to require a black box warning on the drug label for this antibiotic, particularly since data demonstrating the increased mortality risk with the drug had been known to the agency since at least 2010,” wrote Public Citizen in a press release issued last week welcoming the new warnings. “Given the approximately 30 percent higher rate of mortality in subjects receiving tigecycline in comparison to other antibiotics, as well the significantly higher rates of failures to cure serious infections, in comparison to subjects treated with comparator antibiotics, the failure of the FDA to require a black box warning years ago is inexcusable.”

The FDA indicates that the final decision to require the Tygacil black box came after looking at 10 different clinical trials since the 2010 drug safety communication. The agency said that the deaths occurred, in general, as a result of worsening infections, infection complications or other underlying medical conditions.

Tygacil (tigecycline) was approved by FDA for the treatment of certain types of infections in June 2005. Created by Wyeth, which is now a subsidiary of Pfizer, Inc., the drug is approved to treat complicated skin infections, intra-abdominal infections, and community-acquired pneumonia. It is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia).

Tags: Infection, Pfizer, Tygacil, Wyeth