Medical ALERT: Heart Disease Study Links the Antibiotic Biaxin with Increased Risk of Death
Ronald Grisanti D.C., D.A.B.C.O., M.S.
An ALERT issued by the FDA has warned of an increased risk of dying in patients with heart disease who have taken clarithromycin for a two week period compared with patients who received a placebo. Clarithromycin is the generic brand of Biaxin and chemically related to erythromycin. Clarithromycin is in a class of medicines called macrolide antibiotics and is used to treat bacterial infections in many parts of the body such as the ears, throat, lungs, sinuses, and skin. The FDA states that: “The observed difference in mortality became apparent after patients had been followed for one year or longer after the study drug was given. A mechanism by which two-weeks of clarithromycin could cause increased mortality measured after one year or longer is not clear. How the Study was Conducted 4300 people with stable heart disease received either clarithromycin (500 mg once daily) or a placebo for two weeks. The study found that there were 212 deaths in the clarithromycin group and 172 deaths in the placebo group.
The FDA notes that “the observed differences in deaths became apparent about one year or longer after the study drug was given. The finding of a higher mortality rate occurring beyond one year of follow-up after a single two-week course of clarithromycin was an unexpected finding.” Subscribe to Dr. Grisanti's Free Health News and Medical ALERTS
References
Jespersen CM, Als-Nielsen B, Damgaard M, Hansen JF, Hansen S, Helo OH, Hildebrandt P, Hilden J, Jensen GB, Kastrup J, Kolmos HJ, Kjoller E, Lind I, Nielsen H, Petersen L, Gluud C, Jespersen CM.Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial. BMJ. 2005 Dec 8 http://www.fda.gov/cder/drug/infopage/clarithromycin/default.htm
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