Ketek Antibiotic: Dangers, Risks, and What You Can Do If You’re Hurt
Ketek Antibiotic Can Be Extremely Harmful To Your Liver
If you or a loved one has suffered liver problems, liver failure, injury or death as a result of using Ketek, it is time to seek compensation for your pain and suffering with an experienced attorney. Please contact our office today to speak to one of our Ketek side effects lawyers for assistance. Our experienced lawyers will offer you complete information on your legal rights over a free consultation.
Ketek Side Effects – What To Look For
Sanofi-Aventis manufactures the antibiotic drug telithromycin and launched it under the brand name Ketek, in 2004. The antibiotic drug is prescribed in the treatment of respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. The drug has been designed to combat bacterial infections and does not have any impact on viral infections.
Although Ketek has been in news in recent years, for the series of side effects it presents, the drug had been mired in controversy even before its launch. When Sanofi-Aventis (then Aventis), had originally filed its documentation on the drug with the FDA, seeking its approval, in 2001 and 2003, the FDA had noted insufficient evidence and information on the drug’s safety and effectiveness, from the manufacturer, in relation to similar drugs already available in the market.
The agency however approved the drug in 2004, permitting its use in treating respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. Critics note that this may have constituted a serious error on the part of FDA, since there were many safer and less expensive antibiotics that were already available in the market to treat these conditions, while Ketek was being approved.
Ketek Safety According To The FDA
Soon after the launch of the drug, a series of reports emerged on liver damages in patients using the drug. An article published in the Annals of Internal Medicine, in March 2006, cited serious liver injuries associated with the drug, quoting research evidence from three cases — one which resulted in death, another, a liver transplant, and a third case where the patient contracted drug-induced hepatitis. It was also reported that the patient recovered soon after the treatment with Ketek was discontinued.
Following the reports, the FDA initiated a series of safety reviews, which unearthed cases of death and serious liver damages that were linked to the use of the drug. Following the review, the FDA cited 53 cases of liver failure, including five deaths that were directly linked to the use of Ketek.
In 2007, the FDA ordered the manufacturer Sanofi-Aventis to place a black box warning on Ketek’s labeling, which clearly listed the serious side effects, including liver failure which can be caused by the drug. In addition, Sanofi-Aventis was to also include a boxed warning on the contraindication for myasthenia gravis (a disease where the immune system fights the body’s muscle and nerves) patients, as the drug may actually worsen their condition. Also, information relating to visual disturbances and loss of consciousness, that were previously listed in the precautions section, were to be included more prominently in the warnings section on Ketek labeling.
Today, critics question the overall safety of the drug and assert that the Ketek clinical trial process was riddled with fraud and grave compromises, right from the start. It is reported that the FDA granted approval despite having documented evidence on fraudulent clinical trial processes by Aventis. Governmental investigations initiated in February 2008, have been disappointing, and failed to extract adequate information and documentary evidence on the role played by the FDA, Sanofi-Aventis, and the Human and Health Services (HHS) which oversees the FDA, in the Ketek drug trial.
Complications From Ketek? Contact Our Firm Today
Our San Antonio Ketek attorneys have years of rich experience in handling prescription drug cases and will assist you through all the legal formalities, and ensure protection of your rights. Contact our prescription drug attorneys today at 210-888-8888.