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AJN, American Journal of Nursing:
doi: 10.1097/01.NAJ.0000451677.35953.ab
Drug Watch

Labeling Changes for Topiramate (Topamax) and Doripenem (Doribax)

Aschenbrenner, Diane S. MS, RN

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Abstract

* The Food and Drug Administration (FDA) has approved the antiepileptic drug topiramate (Topamax) for a new indication, the prevention of migraines in adolescents ages 12 to 17.

* The FDA has added a new warning to the labeling of the antibiotic doripenem (Doribax), which now warns that the drug increases the risk of death if used to treat ventilator-associated bacterial pneumonia, an off-label use.

Migraine prophylaxis. Topiramate (Topamax) has now been approved for the prevention of migraines in adolescents (ages 12 to 17 years), making it the first drug approved for migraine prophylaxis in this age group. Topiramate was approved as an antiepileptic drug in 1996 and for migraine prophylaxis in adults in 2004.

This change in the labeling follows a January change in which the Food and Drug Administration (FDA) warned about visual field defects with elevations in intraocular pressure in patients taking topiramate. Topiramate has also been the focus of liability lawsuits regarding the failure by Janssen Pharmaceuticals to inform health care providers that the drug increased the risk of cleft lip and palate if used during pregnancy. The drug's labeling has carried a warning about these birth defects since 2011, but the lawsuits involve families whose children were born before then. As with all antiepileptics, topiramate carries a warning that use of the drug increases the risk of suicidal behavior and ideation.

Labeling changes. The FDA has also revised the labeling of the antibiotic doripenem (Doribax) to include a warning that its use increases the risk of death in patients with ventilator-associated bacterial pneumonia. Doripenem isn't approved for the treatment of ventilator-associated bacterial pneumonia or any type of pneumonia. Nor is it approved at dosages higher than 500 mg every eight hours. The FDA continues to believe that doripenem is safe and effective when used for its approved indications: complicated intraabdominal infections and complicated urinary tract infections, including pyelonephritis. The labeling changes follow the announcement that the clinical trial comparing doripenem with imipenem plus cilastatin in the treatment of ventilator-associated bacterial pneumonia was prematurely discontinued in 2012 because of a higher rate of death from all causes at 28 days with doripenem use (23% of subjects undergoing treatment with doripenem died, compared with 16.7% receiving imipenem with cilastatin). Clinical response rates were also lower in those receiving doripenem.

The FDA news release regarding the use of topiramate for migraine prophylaxis in adolescents can be found at http://1.usa.gov/P9gLr4. The safety announcement concerning the risk of death with doripenem used for pneumonia is available at http://1.usa.gov/1gcA0q2.

© 2014 Lippincott Williams & Wilkins. All rights reserved.

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