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Study Identifies Adverse Effects for Newer Antimicrobial Drugs

Filed September 17th, 2013 edlieber1

The American Society for Microbiology recently posted study findings revealing adverse effects for 11 antimicrobial drugs approved by the U.S. Food and Drug Administration (FDA) in the past seven years.

The researchers analyzed adverse events using data from the FDA’s Adverse Event Reporting System (FAERS). They identified multiple drug effects that are not disclosed on medication labels, Drug Safety Monitor reports. The FAERS data covered the period from November 1, 1997 to December 31, 2012. The study was not funded by any external sources.

The investigators identified new adverse effects for the following drugs: darunavir (Prezista), doripenem (Doribax), boceprevir (Victrelis), and raltegravir (Isentress). Notable adverse effects include premature labor, sudden infant death syndrome, ventricular hypertrophy, acute coronary syndromes, and congenital anomaly (darunavir); liver dysfunction and hyperchloremia (doripenem); weight loss (boceprevir); and congenital heart valve disorders and sudden infant death syndrome (raltegravir). The researchers conclude that further study is needed to determine whether there is a direct connection between these particular drugs and the adverse effects, according to Drug Safety Monitor.

Prezista (Janssen Pharmaceuticals) and Isentress (Merck) are approved as part of a combination treatment for HIV; Doribax (Janssen) is for infections including complicated urinary tract infections; Victrelis (Merck) is used to treat hepatitis C.

“Our goal was to qualitatively and quantitatively review the FDA Adverse Event Reporting System (FAERS) database to provide clinicians with a general understanding of the comparative occurrence of clinically important adverse events seen in newly approved antimicrobials approved by the FDA in the past seven years,” the researchers write in the posting on the American Society for Microbiology website.



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