The U.S. Food and Drug Administration has banned uses of the antibiotic Ketek, which has been linked to liver injury, liver failure and cases of patient deaths. A "black box" warning has been issued for remaining uses of the drug.
The FDA restrictions were announced Feb. 12, 2007, prohibiting its continued use for sinusitis and bronchitis. Ketek, generically telithromycin, made by SanofiAventis, has sold more than five million prescriptions since it was approved in April 2004.
Ketek may still be used for certain respiratory ailments, such as pneumonia, but it must contain label warnings about its potential serious side effects. The FDA has advised patients and doctors using Ketek to be on the alert for symptoms of liver problems, such as jaundice, yellowing of the eyes or skin, or blurry vision. (See stories: CNN
The FDA’s latest news release about Ketek said that it had determined that "the balance of benefits and risks no longer support approval of the drug" for sinusitis and bronchitis. Ketek’s remaining approval would be for the treatment of community-acquired pneumonia, or cases contracted outside hospitals or long-term care facilities. Even in pneumonia cases, Ketek should not be used in patients with myasthenia gravis, the agency said.
Potential problems with Ketek first became public in January 2006 when doctors in North Carolina reported in the Annals of Internal Medicine three cases of acute liver failure in previously healthy patients who took Ketek. Later, newspapers reported on an internal FDA memo noting 12 cases of liver failure among Ketek patients, four of whom died.
According to reports, the FDA investigators compared data from Ketek and three other similar drugs and found that liver failure occurred at much higher rates among those taking Ketek. Also, an FDA memo noted a "rapid tempo and severity of injuries" among the patients. One report noted "massive tissue death" among two Ketek patients, while another noted a patient became ill after taking just a single dose of Ketek.
According to The Los Angeles Times, more than just the safety of the drug was being looked into. The newspaper said the FDA is also probing alleged scientific fraud in a large safety study of Ketek, with criminal investigators from the agency having uncovered "serious data integrity problems."
U.S. Sen. Charles Grassley also has said he was considering holding congressional hearings on Ketek and he noted parallels with the painkiller Vioxx. Grassley has criticized the FDA with too readily accommodating drug companies in granting approval of new drugs. (Vioxx was recalled in 2004 after it was linked to an increased incidence of heart attacks and strokes.)
Kline & Specter, PC, with some 30 experienced attorneys, several of them also highly regarded doctors, is one of the nation's leading law firms with the ability to litigate pharmaceutical drug lawsuits. However, we are no longer accepting cases involving Ketek.