Does New Warning For Ketek Go Far Enough?

Baltimore, MDAt least four people have died and 37 others suffered liver damage after taking Ketek, an antibiotic made by Sanofi-Aventis. Now, many people are investigating the possibility of filing lawsuits after they suffered serious complications from taking the drug. The U.S. Food and Drug Administration (FDA) has responded by changing the labeling but the changes come too late for those who have developed liver problems after taking Ketek.

Earlier this year federal regulators limited the approved uses for Ketek and requested new safety warnings for the drug. However, given the serious side effects associated with Ketek, including liver damage, compared with the minor illnesses it treats, some medical professionals are left wondering if Ketek should be left on the market at all.

In February officials at the U.S. Food and Drug Administration (FDA) announced that Ketek would not be used to treat bacterial sinus infection and bacterial exacerbations of chronic bronchitis. However, the agency did allow Ketek to be used to treat community-acquired pneumonia of mild to moderate severity.

Some scientists are worried that the risk of liver damage is not worth the benefit of treating mild pneumonia. Part of the concern is that Ketek has never been proven to be any more effective than other antibiotics at curing bacterial infections but does have a higher risk of serious complications than the other antibiotics.

Ketek has been a headache for its maker, Sanofi-Aventis, for a while, but it has also caused problems for the FDA. A U.S. Senate committee found that the FDA did not inform advisors that a safety study regarding Ketek was filled with incorrect data and involved misconduct on the part of the researchers.

Furthermore, the agency has come under fire after reports surfaced that FDA leadership warned other officials to keep their concerns to themselves. Some FDA officials who expressed concern about Ketek or other drugs claim they were retaliated against by senior officials, including being subjected to criminal investigations. A former FDA medical officer even testified against Ketek during an advisory panel meeting, saying he was pressured to soften his review of the antibiotic.

The new warning for Ketek warns that patients with myasthenia gravis should not take Ketek. A black box warning has also been included warning patients that Ketek has a risk of serious complications including liver failure. However, given that at least four people have died after taking Ketek for relatively minor conditions, is a black box warning strong enough for the drug?