When new drugs are harmful: Telavancin (VIBATIV) for skin infections

Jennifer Yttri, Ph.D.

June 2013

Your skin is your first defense against infection. But, when you get a wound in your skin, whether from an injury, surgery, or a complication from diabetes, you can develop a skin infection. The bacteria that are normally found on the skin or in hospitals or homes can potentially cause an infection. Most of the time these infections go away after a few days but in some cases a more serious infection happens and these are called complicated skin infections.

Complicated skin infections are usually treated by antibiotics and surgery to remove the infected skin tissue. Unfortunately, many of the bacteria that cause these infections can be resistant to antibiotics.1 The most commonly prescribed antibiotic for treating skin infection is vancomycin, which is prescribed as a pill sometimes under the name Vancocin. Vancomycin was first approved by the FDA in 1958, but after 50 years of use, bacteria are becoming resistant to vancomycin.2 Therefore, there is a push for drug companies to make new antibiotics.

Another antibiotic for treating complicated skin infection is telavancin (sold under the name VIBATIV). Since its approval in 2009, over 125,000 patients have used telavancin.3 While the drug works well for treating complicated skin infections, it can also cause serious side effects.4 That’s why the drug is only approved for complicated skin infections, but not for less serious skin infections.  That is also why it has several black box safety warnings, the highest level of warning the FDA can require (similar to the black box warning on cigarettes).

  • Telavancin can alter your heart rate (measurement called QT interval) which can cause death.
  • Telavancin may not work well in patients with poor kidney function and can make kidney problems worse.
  • Telavancin may cause birth defects when used by pregnant women. While never studied in humans, telavancin is known to cause birth defects in animals. That’s why pregnant or potentially pregnant women should avoid using telavancin. If a pregnant woman must take telavancin, she should be in a registry that was created to find out more about the risks and to report any complications. More information on the registry can be found here. If you are pregnant and have to use telavancin (Vibativ), call 1-855-633-8479 to join the registry.
  • Patients taking this drug were more likely to die than patients taking vancomycin for complicated skin infections. That’s why telavancin should only be used as a last resort, when other antibiotics are not working.

Many newer antibiotics that were approved in the last decade have more serious risks than older antibiotics. In fact, in can take decades to determine the risks of specific antibiotics.  For example, the Z-Pak has been a popular antibiotic for 20 years, and FDA only recently warned that it can cause fatal side effects, especially in older patients and those with heart problems. It is important to know these risks before using a new drug, and it is a good reason to try an older antibiotic first. Physicians, patients, and families should read all labels, inserts, and warnings to learn about these risks.  Unfortunately, not all physicians do so, and that’s why patients must read the labels themselves (usually available online at www.drugs.com ).

It is also important to understand that the FDA approves drugs for a specific purpose, not to treat all related medical problems.  For example, taking telavancin for a less serious skin infection would be considered an “off-label” use that is NOT approved by the FDA. When you take a drug for an off-label use, you can’t be sure that its benefits outweigh its harms.  For example, a more dangerous drug might be worth the risk if it can cure a potentially deadly skin infection, but not if a safer drug that works just as well is also available.  Newer, more expensive antibiotic drugs are not necessarily better.

In June 2013, Vibativ was approved for use against hospital and ventillator acquired pneumonia infection. While FDA only approved its use for cases where no alternative treatments are suitable, the restriction is unlikely to be enforced.

  1. Lee, S.Y, Kuti, J.L., and Nicolau, D.P. Antimicrobial management of complicated skin and skin structure infections in the era of emerging resistance. Surgical Infections 2005.  
  2. Vancomycin. Accessed January 10, 2013. http://en.wikipedia.org/wiki/Vancomycin  
  3. Briefing document Anti-infective Drugs Advisory Committee Meeting. “Telavancin for the treatment of nosocomial pneumonia”. Accessed January 10, 2013. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM329482.pdf p.12.  
  4. VIBATIV Prescribing Information. Accessed January 10, 2013. http://www.vibativ.com/docs/VIBATIV_PI_Final.pdf  

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