Study Reveals Previously Unidentified Adverse Events Tied to Newer Antimicrobials

Just released research as identified new and significant adverse effects tied to four antimicrobial medications.

The newly identified adverse reactions were seen in four antimicrobials, according to September 13, 2013 findings from a study that reviewed 11 microbials and was posted on the American Society for Microbiology’s website, AdverseEvents.com reported. The study team analyzed data from the U.S. food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS), and discovered, which found a number of drug effects that were 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, MedPage Today reported. The team discovered that the agents might carry significant and unlabeled risks that the FDA would consider to be meaningful, said Khadem, who presented the findings at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

The researchers used FAERS data from November 1, 1997 to December 31, 2012. They aggregated and standardized the data using the AdverseEvent RxFilter process, according to AdverseEvents.com. Newly discovered adverse effects were found for the following four drugs; many of these reactions are not included the drugs’ packaging:

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

Researchers concluded that additional research is needed to determine if there is a direct connection between these drugs and the adverse events recently discovered. The researchers also noted that the analysis did not consider the number of patients taking each medication, according to AdverseEvents.com.