Adverse Events Linked to New Antimicrobial Drugs: Study

A new report has identified a number of potentially serious side effects associated with several new antimicrobial drugs that were recently approved by the FDA, including medications like Victrelis, Issentress, Doribax and Prezista.  

The drugs are used to treat a variety of microbial illnesses including hepatitis C, HIV/AIDs and fungal infections. However, a report published by the American Society for Microbiology on September 13 indicates that a review of adverse event reports has identified a number of problems associated with the medications that may not be included on the warning label.

Researchers conducted a review of the FDA Adverse Event Reporting System (AERS) and found that six of the 10 antimicrobials investigated were associated with side effects that are not listed on the labels, including liver dysfunction, hyperchloremia, weight loss, premature labor, sudden infant death syndrome, ventricular hypertrophy, acute heart problems and congenital defects in children.

Specifically, the HIV drug Prezista (darunavir) was linked to cases of premature labor, sudden infant death syndrome, ventricular hypertrophu and congenital anomalies. However, the most commonly reported side effects were coronary artery disorders. Doribax (doripenem), which is used to treat bacterial infections was linked to a number of cases of liver dysfunction. Victrelis (boceprevir) is used to treat hepatitis C and was linked to numerous cases of unexpected weight loss. Issentress, another HIV drug, was linked to sudden infant death syndrome and congenital heart failure.

Researchers noted that the report shows the failings of relying too much on clinical trials.

“Although clinical trials serve as the gold standard for demonstrating the safety and efficacy of newly approved drugs, unfortunately they allow for study of only a homogenous patient population for a finite period of time and likely do not reflect real-world use, researchers concluded.