On February 12, 2007 the Food and Drug Administration (FDA) announced that the antibiotic Ketek, manufactured by Sanofi-Aventis, had new labeling and warnings after it was found last year that three patients experienced severe liver problems.
The crisis first came to light in an article that appeared in the Annals of Internal Medicine entitled: “Severe Hepatotoxicity of Telithromycin: Three Case Reports and Literature Review.” The report found that within days of receiving Ketek (the brand name of the drug “telithromycin”), each patient suffered from symptoms associated with severe hepatitis including jaundice and liver failure. One recovered, one required a liver transplant, and one ultimately died of liver damage.
The authors of the study also noted that the FDA’s own Adverse Event Reporting System had mention of ten other cases where both Ketek and liver problems were present, suggesting that there may have been examples of this connection beforehand. However, the study and these three cases were the only investigation into a possible link between the two.
In light of these findings, the FDA along with Sanofi-Aventis narrowed its approved uses to the treatment of community-acquired pneumonia. Ketek is no longer approved for bronchitis or sinusitis due to the risk of serious liver injury. The included warning also states that those afflicted with myasthenia gravis, a muscular disease, should not be prescribed Ketek.
Further, the new labeling has added stronger warnings about the risk of liver injury, vision problems, and loss of consciousness for those taking Ketek.
In a Question and Answer section on the FDA website, the agency noted that those taking Ketek should continue to do so until instructed to stop by their physician. However, patients who experience fainting, blurred vision, or notice their skin turning yellow should seek immediate medical attention. Those with myasthenia gravis should stop taking Ketek.
Despite the new labeling, many are questioning why Ketek was approved for use in the first place. The drug was rejected by the FDA in 2001 and 2003 but was ultimately approved in 2004, apparently despite the objections of several FDA scientists.