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Previously Unidentified Adverse Events Discovered for Newer Antimicrobials

Sep 17, 2013

Emerging research reveals newly identified adverse effects are associated with a number of antimicrobial medications.

The research involved 11 antimicrobials and newly identified adverse reactions were seen in four of the drugs, according to September 13, 2013 findings from a study that was posted on the American Society for Microbiology’s website, reported. The study involved an analysis of data from the U.S. food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS), which found a number of drug effects not disclosed on the drugs’ labels.

The study was conducted by Tina Khadem, PharmD, of the University of Rochester Medical Center in New York, and colleagues, according to MedPage Today. The researchers found that the agents might carry significant and unlabeled risks that the FDA would consider meaningful, according to Khadem, who presented the findings at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

The researchers used FAERS data from the period between November 1, 1997 and December 31, 2012; it was aggregated and standardized via the AdverseEvent RxFilter process, according to Adverse effects were discovered for the following drugs; many reactions are not included on the drugs’ package inserts, reported:

  • Prezista (darunavir): The HIV medication was associated with 15 cases of premature labor, one case of sudden infant death syndrome, one case of ventricular hypertrophy, 38 cases of acute coronary syndromes, and 10 cases of congenital anomaly;
  • Doribax (doripenem): Used in complex intra-abdominal and urinary tract infections and was associated with 15 cases of hepatic dysfunction and hyperchloremia;
  • Victrelis (boceprevir): Used in treatment of chronic hepatitis C; associated with 93 cases of weight loss;
  • Isentress (raltegravir): Three cases of congenital heart valve disorders and four cases of sudden infant death syndrome were associated with this HIV drug.

Researchers concluded that additional research is warranted to determine if there is a direct connection between these drugs and adverse events, and noted that the analysis did not consider the number of patients taking each medication, according to

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