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Antibiotic’s Label Should Include a Stronger Warning About Higher Mortality Rate, Public Citizen Tells FDA

Oct. 26, 2011 

Antibiotic’s Label Should Include a Stronger Warning About Higher Mortality Rate, Public Citizen Tells FDA

Public Citizen Calls on FDA to Require Black Box Warning on Label for the Antibiotic Tigecycline

WASHINGTON, D.C. – The Food and Drug Administration (FDA) should place a black box warning on an antibiotic used to treat a wide range of infections because of a higher mortality rate associated with taking the drug than other widely used antibiotics, Public Citizen said in a petition sent today to the agency.

The antibiotic, tigecycline, also known as Tygacil, was approved by the FDA in 2005 to treat complicated skin infections and intra-abdominal infections and in 2009 to treat community-acquired pneumonia.

But in 2010, the FDA issued a safety alert to health care professionals informing them of an increased mortality rate associated with the use of intravenous tigecycline compared to that of other antibiotics. The agency said that alternatives to tigecycline should be considered in patients with serious infections. At the same time, the FDA required that the drug label be modified to include data about the increased mortality risk, but these warnings were inadequate, Public Citizen said in the petition. Critical safety information does not appear in a black box warning at the top of the label and fails to describe appropriate restrictions on 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.”

Public Citizen calls on the FDA to add a black box warning to the antibiotic’s label indicating the increased risk of death and advising that it should be used only as a last-resort antibiotic and then only in combination with one or more bactericidal antibiotics (antibiotics that directly kill bacteria, rather than interfere with bacteria growth). Public Citizen also is petitioning the agency to require an FDA-approved medication guide to be distributed to patients, as well as a “Dear Doctor” letter to physicians, warning them of the dangers of the drug and the need for restricted use.

Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.