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.

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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.

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1 Comments

  • BarbaraFebruary 23, 2015 at 1:06 am

    When I learned there was a newly-approved drug, Victrelis, for treatment of hep-C I was thrilled. A prior round of treatment with pegintron and ribavirin wasn't successful, so this was my last hope. (I contracted hep-c from a blood transfusion in 1990.) I began treatment July 1, 2011, and included the Victrelis in the treatment on 9/1/11 as per my doctor's instructions. I was severely weak and ge[Show More]When I learned there was a newly-approved drug, Victrelis, for treatment of hep-C I was thrilled. A prior round of treatment with pegintron and ribavirin wasn't successful, so this was my last hope. (I contracted hep-c from a blood transfusion in 1990.) I began treatment July 1, 2011, and included the Victrelis in the treatment on 9/1/11 as per my doctor's instructions. I was severely weak and getting weaker. By the end of Sept. the HCV RNA blood test showed hep-c was no longer detected. However, my red and white blood cell counts were dropping uncontrollably. My hemotologist/oncologist immediately ordered a blood transfusion to try to stimulate blood cell creation, but no luck. Then he started giving me weekly injections of Procrit for the same purpose, no luck. Then he added Neupogen, no help. My red and white blood cell counts were down to 1.8 and still dropping. The hemotologist advised the treating doctor that I had "Pancytopenia after treatment for hepatitis C." On Nov. 30, 2011 I quit the treatment because it started attacking my brain. May 2014 I was having what I suspected were mini-strokes. My neurologist immediately ordered an MRI of my brain and an EEG. Results of MRI: "...early microvascular ischemic disease." I was, in fact, having TIAs (mini-strokes). This NEVER happened prior to Victrelis! And this is a known, though rare side effect of Victrelis. Results of EEG: "...This was an abnormal EEG recording. There was evidence for abnormal electrogenisis in the left Frontal-temporal area." I was now experiencing partial epileptic seizures, which also NEVER happened before Victrelis! This is also a known, though rare side effect of Victrelis. I don't have Hep-C anymore, but now I have more serious brain issues from the Victrelis. I asked my treating physician whether anyone else who was on the Victrelis was experiencing these things and he said it was possible, but they probably had not had the MRI and/or EEG to confirm.

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