Raxar, also known as Grepafloxacin hydrochloride, is used to treat bacterial infections such as pneumonia and gonorrhea. It is marketed by GlaxoSmithKline. The FDA approved the drug in November 1997. Raxar was withdrawn from the market in October 1999 because of its effect on QT interval prolongation which can lead to cardiac events and sudden death. Severe side effects include difficulty breathing, closing of the throat, hallucinations, irregular or slow heartbeats, muscle or joint pain, and liver damage. Common side effects include headache, nausea, diarrhea, ringing of the ears, drowsiness or insomnia. Sales in the U.S. generated $23.5 million in total revenue for the GlaxoSmithKline. Clinical trials indicated heart arrhythmia in patients using 600-milligram doses which resulted in death; however, patients using 400-milligram doses did not manifest the irregularities. Individual lawsuits were filed as a result of 13 deaths attributing to the use of Raxar. Settlements were reached with the individual plaintiffs in the fall of 2000.
Development and Release
Raxar was developed by Otsuka Pharmaceuticals and licensed for sale to GlaxoWellcome (which became GlaxoSmithKline in 2000) as an antibiotic used to treat certain bacterial infections such as pneumonia and gonorrhea. The U.S. Food and Drug Administration (FDA) approved Raxar for sale to the general public in November of 1997. In the short time it was on the market before it was deemed too dangerous for sale, the product generated $23.5 million in sales in the United States.
Health Problems Associated With Raxar
In reports presented to the FDA at the time of Raxar’s approval, there were concerns that the drug caused heart-rhythm disturbances in patients. Although such irregularities did not occur in patients who took the 400-milligram dose of Raxar during the clinical trials, four of the subjects taking 600-milligram doses died as a result of a heart arrhythmia soon after withdrawing from the clinical trial. Glaxo and the FDA then sought to minimize the risk of harm to any individual through precautionary labeling.
While it was not clear at the time that Raxar was the culprit at the time of approval, one FDA medical officer noted that the question was “open.” Still, Glaxo maintained that the heart arrhythmia was not caused by Raxar and highlighted the fact that there were no “deaths or permanent disabilities” to patients who took the drug at 400-milligram doses. Conspicuously missing from the warning label, however, were the deaths that occurred in clinical trials to patients taking the 600-milligram dose.
According to the FDA, an estimated 13 people died as a result of their Raxar prescription. Most of the fatalities associated with Raxar were in patients under 70 years of age, with no reported prior heart irregularities. In October of 1999, almost two years after the product came to market, Glaxo pulled Raxar from shelves. The company issued an accompanying statement that it was “no longer convinced that the benefits of Raxar outweigh the potential risk to patients.”
Because so relatively few were exposed to Raxar’s risks, just 13 deaths were attributed to the drug—a relatively small number in the context of dangerous drug litigation. Glaxo reportedly reached individual settlements with the plaintiffs in the fall of 2000.