Ketek Side Effects Injury Lawsuits. Our Ketek injury lawyers and attorneys are currently representing hundreds of people who suffered liver damage as a result of this defective antibiotic Ketek. Ketek has been the subject of numerous Food & Drug Administration (FDA) safety reviews, and in 2007, the FDA ordered Sanofi-Aventis to place a black box warning on the Ketek label regarding serious side effects, including liver failure. In addition to its numerous safety issues, the clinical trials for Ketek were riddled with fraud, a situation that has resulted in a long-running congressional investigation. The Ketek injury lawyers and attorneys at our firm are working to insure that Sanofi-Aventis is held accountable for the injuries caused by this defective drug and to help the victims of Ketek.
Our Dedicated Experienced Lawyers and Attorneys Have Years of Experience Handling Defective Drug Lawsuits Such as Ketek.
Critics of Ketek, including the defective drug lawyers at our firm, have long questioned the wisdom of the FDA decision to approve Ketek. When Aventis (now Sanofi-Aventis) submitted Ketek to the agency for approval in 2001 and 2003, the FDA refused on the basis that the drug maker had not provided sufficient evidence that Ketek was as safe and effective as antibiotics already on the market. However, in 2004 the FDA relented and approved Ketek for the treatment of respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. The Ketek injury lawyers at our firm believe the FDA committed a serious error in approving Ketek, especially considering the fact that so many safer, less expensive antibiotics were already available to treat the conditions that Ketek was intended to treat.
Within months of its introduction to the market, some patients being treated with Ketek experienced liver problems. In January 2006, the FDA issued a Public Health Advisory warning about serious liver problems associated with the use of Ketek. The FDA warning followed the early release via the internet of a March 2006 article published in the Annals of Internal Medicine. In that article, researchers detailed three cases of severe liver problems, including one death, that occurred in patients at a North Carolina hospital after they began taking Ketek. One patient at Carolinas Medical Center in Charlotte, N.C., died after taking Ketek. Another patient received a liver transplant, and the third contracted drug-induced hepatitis but recovered after treatment with Ketek was stopped.
Our Ketek injury attorneys are aware of evidence that suggests the FDA and Sanofi-Aventis knew of liver problems associated with Ketek long before the Public Health Advisory was issued. According to a statement by the consumer advocacy group Public Citizen following that advisory, “Panelists at the Jan. 8, 2003 advisory committee meeting reviewed data from a large U.S. safety study that indicated a risk for heart, liver, and eye toxicity with [Ketek] use. It was also revealed at this meeting-three years ago— that the FDA already had received 54 reports of liver-related adverse drug reactions from countries in which the drug had already been previously marketed. Nineteen of these 54 reports were categorized as serious.
Ketek Labeling Changes
On May 19, 2006 the FDA said it was able to connect 12 cases of liver failure, which included four deaths, to Ketek. Based upon these finding, the FDA urged Sanofi-Aventis to add a warning label to the drug. The FDA eventually confirmed 53 cases of liver failure in patients using Ketek, including five deaths. In February 2007, Sanofi-Aventis finally added a black box warning concerning liver failure to the Ketek label and the FDA severely restricted its use. In addition, Sanofi-Aventis also added a boxed warning and contraindication for myasthenia gravis patients. Information regarding visual disturbances and loss of consciousness, previously in the precautions section, was moved to the more prominent warnings section of the Ketek label. Our Ketek injury lawyers do not feel the actions taken by the FDA and Sanofi-Aventis go far enough, and believe that this defective drug should never have been allowed on the market at all.
The FDA approved Ketek despite documented evidence of fraud in some of the clinical trials Aventis submitted to the agency during the approval process. This fraud included instances where doctors enrolled phony subjects in the Ketek trials and falsified consent forms by forging subject signatures One doctor actually was charged criminally and was sent to jail because of Ketek fraud. In October 2007, the FDA sent Sanofi-Aventis a warning letter regarding the conduct of Ketek clinical trials. The FDA said that Aventis own records showed that there were many instances of serious protocol violations and regulatory noncompliance by clinical investigators involved in the Ketek clinical trial. According to the warning letter, the FDA found no evidence that Aventis did anything to correct the problems with the Ketek clinical trial, or remove doctors responsible for violations from the study. The FDA also criticized the drug maker for failing to make sure the Ketek clinical trail was run properly and for allowing unqualified investigators to participate.
In February 2008, a congressional committee looking into Ketek fraud subpoenaed Health and Human Services (HHS) Secretary Michael Leavitt, asking him to produce underacted records prepared for the FDA commissioner’s appearance at a March 2007 hearing on Ketek. Leavitt’s department oversees the FDA, and both FDA and HHS had refused to provide those documents in the past. At the same time, the panel also approved subpoenas for two current FDA investigators, one former FDA investigator and a former employee of a company commissioned by Aventis to monitor the fraudulent Ketek clinical trials.
At a hearing in Congress on February 12, testimony from one subpoenaed witness revealed that in 2002, the FDA had denied the request of one of its own agents to investigate whether or not Aventis knew about the Ketek fraud as it happened. For his part, Secretary Leavitt refused to turn over subpoenaed documents to the committee, causing some lawmakers to threaten him with contempt charges. Because of the obstruction on the part of Leavitt, the FDA and Sanofi-Aventis, governmental investigations have failed to get to the bottom of the Ketek debacle. It is becoming increasingly clear that many of the questions arising from the Ketek debacle might only answered in the course of Ketek lawsuits filed on behalf of those injured by this defective drug.