Sanofi-Aventis adds Black Box Warning to Ketek’s Label
In February 2007, Sanofi-Aventis, Ketek’s manufacturer, added a black box warning to Ketek’s label. The warning states that Ketek users have an increased risk of severe liver damage. Additionally, it warned against Ketek use by patients suffering from prior muscle weakness. The FDA also withdrew its approval of Ketek for treating bronchitis and sinusitis. Furthermore, the FDA restricted Ketek use to community acquired pneumonia (pneumonia acquired from outside a hospital).
In May 2006, the Annals of Internal Medicine published an article that described three Ketek users in one hospital that developed severe liver problems. One patient required a liver transplant and another patient died. The three patients had no prior liver problems.
Prior to FDA approval in April 2004, there were 54 reports of liver damage in Ketek users from countries where Ketek was available. Of those 54 reports, 19 cases described serious liver damage. In January 2006, the FDA announced that Ketek is allegedly linked to 23 severe liver damage reports, twelve liver failure reports, and four deaths within the first two years on the market. These reports prompted experts, including the consumer advocacy group Public Citizen, to criticize the FDA’s approval of Ketek.
Ketek liver damage occurs quickly and Ketek’s toxicity directly destroys liver tissue. The liver can regenerate tissue when mildly damaged, but severe liver damage can lead to liver failure. Liver failure occurs when the liver stops functioning. In some cases, liver failure may be irreversible and a liver transplant is necessary.
Ketek is also linked to a serious liver disease called Hepatitis. Hepatitis occurs when the liver becomes inflamed. The most severe cases of Hepatitis could be fatal.
Ketek is an antibiotic approved to treat pneumonia, a bacterial infection. Ketek prevents bacteria from reproducing and stops the infection from spreading. Originally, the FDA refused to approve Ketek because cheaper and safer alternatives were available. Ketek received FDA approval, however, in April 2004 and it has since been prescribed to more than 3.5 million patients in the United States.
If you or a loved one has taken Ketek and suffered severe side effects, contact our Ketek attorneys for a free and confidential case review today.