Antibiotic Stripped of 2 of 3 Approved Indications

This week, the U.S. Food and Drug Administration (FDA) removed 2 of 3 approved indications for the semi-synthetic macrolide antibiotic telithromycin (Ketek, manufactured by sanofi-aventis).

Ketek loses its indication for (1) acute bacterial sinusitis and (2) acute bacterial exacerbations of chronic bronchitis, often abbreviated as “ABECB”. Ketek remains approved for community acquired pneumonia of mild to moderate severity that is acquired outside of hospitals or long-term care facilities.

Part of this labeling change includes an update on the antibiotic’s product labeling contraindicating in those with myasthenia gravis.

According to the FDA, this labeling change is based on re-evaluation of the risk-benefit assessment for patients who are taking Ketek for their respiratory infections.

While my headline (“…stripped of”) may be dramatic, this is no drama compared to some of the marketing tactics that antibiotic manufacturers engage in the promotion of antibiotics. I’m not singling out sanofi-aventis here. Drug companies, consumers, and doctors all played a part in the ridiculous overuse of antibiotics in our society today. Yes, it’s so much easier to blame the drug companies. Next time when you get a respiratory tract infection, try “sticking it out” for at least one week before you go to the doctors. That alone gives you an idea of how consumers contribute to the overuse of antibiotics. Then, if you do go to the doctors, see if the doctor immediately writes you a prescription for an antibiotic. On the other hand, if you waited for 2 hours (like we did over the winter holidays) to see a doctor, see if you’d be satisfied to be told by the doctor that you don’t need antibiotics and just go home and drink lots of fluids.

FDA Announcement of Ketek Labeling Change

Good People can cause antiobiotic resistance

Patient Information Sheet for Telithromycin (marketed as Ketek)

Telithromycin on Wikipedia

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