In response to new information linking the popular antibiotic Tygacil (tigecycline) to an increased mortality rate, the consumer watchdog group Public Citizen has called on the FDA to add a Black Box Warning to the drug’s label. According to Public Citizen, critical safety information does not appear on the label describing appropriate restrictions for the use of the drug. The group is also petitioning the FDA to require a medication guide to be distributed to patients, as well as a ‘Dear Doctor’ letter to physicians warning them of the dangers associated with Tygacil.
Tygacil Update 9/27/13: Labels of the widely-prescribed antibiotic drug Tygacil (tigecycline) will be updated to include a boxed warning describing an increased risk of death when the drug is used for approved and non-approved purposes, the FDA announced today. This action was taken in response to an analysis conducted following a Tygacil Drug Safety Communication that was issued in September 2010.
What’s the problem?
October 26, 2011 – According to a petition issued today by Public Citizen, the U.S. Food & Drug Administration should place a so-called ‘black box’ warning – the strictest warning allowed by law – on labels of Tygacil, a powerful antibiotic used to treat a wide range of infections.
Tygacil was first approved for sale on the U.S. market in 2005 to treat complicated skin and intra-abdominal infections. Then in 2009, the FDA approved Tygacil for the treatment of community-acquired pneumonia.
Tygacil is chemically similar to tetracycline antibiotics, which are designed to work against large numbers of bacteria. The drug bonds to bacterial ribosomes, which are organelles inside the bacteria that produce the cell’s proteins. This prevents the bacterial ribosomes from producing important proteins that are needed for growth and multiplication of the bacteria. Tygacil does not kill bacteria – it simply prevents it from multiplying.
Side effects of Tygacil
The serious side effect most often reported in Tygacil users is unexpected death. Less severe side effects associated with the drug may include:
- diarrhea that is watery or bloody
- severe headache
- pain behind your eyes
- ringing or throbbing in your ears
- problems with vision
- severe pain in your upper stomach spreading to your back
- fast heart rate
- feeling like you might pass out
- easy bruising or bleeding
- unusual weakness
- sleep problems (insomnia)
- increased sweating
- vaginal yeast infection
FDA Warning on Tygacil
Last year, the FDA issued a press release informing the public and medical communities that the intravenous use of Tygacil had been associated with an increased risk of mortality compared to that of other antibiotics. The administration cautioned that alternatives to Tygacil should be used in individuals with severe infections. The FDA also required Pfizer to update Tygacil’s label to include information about the increased risk of mortality associated with the drug. But according to Public Citizen’s petition, these warnings are inadequate because they fail to describe appropriate restrictions for the use of the drug.
“Given the approximately 30 percent higher rate of mortality in subjects receiving tigecycline, as well the significantly higher rates of failures to cure serious infections, in comparison to subjects treated with comparator antibiotics, the content and placement of the warnings in the current drug label are woefully insufficient,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “Because of the increased death rate and the likely inappropriate use of tigecycline as a first-line, rather than last-resort, antibiotic for serious infections without simultaneous administration of other antibiotics, it is inexcusable that there is currently no black box warning for tigecycline. Such a warning, accompanied by stronger warnings describing appropriate restrictions on its use in other parts of the label, clearly is warranted to more effectively advise physicians about the dangers of using tigecycline to treat serious infections and to better protect public health.”
An FDA analysis of more than a dozen independently conducted clinical trials found that Patients given Tygacil to treat pneumonia had a 20% chance of dying, compared to only 12% from competing antibiotics. Under certain circumstances the risk spiked even higher, including instances the drug was used for ventilator-assisted and hospital-acquired pneumonia. The fact that Tygacil has a higher death rate in all categories and spikes in a few specific ones led the FDA to issue the 2010 warning.
Public Citizen is calling on the administration to require updated verbiage indicating the increased risk of death associated with Tygacil. The group believes physicians should only use Tygacil as a last resort, and only then in combination with one or more bacterial antibiotics. Public Citizen has also petitioned the FDA to require a medication guide to be distributed to patients, as well as a ‘Dear Doctor’ letter to physicians cautioning them about the dangers of the drug and the need for restricted use.