The antibiotic Raxar was approved in November 1997 despite evidence from clinical studies suggesting it could cause several fatal heart-rhythm disruptions. Click on FAQ on Arrhythmia: Raxar, to learn more about this issue.
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.
If you or a loved one has suffered an injury as a result of taking any drug or supplement, call Law Offices of Robert Dourian now at 800-790-8856 or CLICK HERE TO SUBMIT A SIMPLE CASE FORM. The initial consultation is free of charge, and if we agree to review your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. Don't delay! You may have a valid claim and be entitled to compensation for your injuries, but a lawsuit must be filed before the statute of limitations expires.