The antibiotic Raxar was approved in November 1997 despite evidence from clinical studies suggesting it could cause several fatal heart-rhythm disruptions.
When Raxar clinical trials came under review by the FDA, a medical officer suspected that two out of four patients who died after taking Raxar in clinical trials possibly suffered heart-rhythm disturbances caused by the drug. FDA officials, however, chose to approve the drug and decided not to require any mention of the deaths on the drug's label. Glaxo, the manufacturer of Raxar, also opted not disclose the possibility of fatalities from heart-rhythm disturbances on the drug label.
Instead, Glaxo merely indicated on Raxar labels that "there were no deaths or permanent disabilities" among those who took the drug in 400-milligram doses. The statement was true, if incomplete: The four patients who died in the clinical study took 600-milligram doses of Raxar. According to records filed with the FDA, Raxar has been cited as a suspect in the 13 reported deaths.
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