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FDA Issues Warning on Antibiotic

Dec 11, 2005 |

Officials with the Food and Drug Administration issued an alert to the general public Friday warning consumers that an antibiotic made by Abbott Laboratories could be deadly for heart disease patients.

Issuing the notice on their Web site, the FDA says it has not reached a final conclusion in the study, but released the warning as part of a trend to warn consumers as early as possible when potential problems with medications arise.

Officials at Abbott Laboratories said the results were a "random finding" and they contrast with years of research proving the drug's , named Biaxin, overall safety.

The study being cited by the FDA was published Thursday in the British Medical Journal. According to Reuters, of 4,373 Danish heart disease patients who took Biaxin, 9.8 percent died within three years. Comparatively, those patients who took the placebo had a death rate of 7.8 percent. There was no difference in the death rates until one year following therapy.

Researchers involved with the study said the results were surprising and that the long-term safety of Biaxin should be studied further.

The scientists said the result was surprising and that the long-term safety of Biaxin should be further examined.

The FDA said the warning was a preliminary analysis and has not yet reached a final decision regarding Biaxin.

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