Ketek Liver-Injuries and Deaths

Ketek Liver-Injuries and Deaths: FDA Warnings Come too Late for Dangerous Drug

Ketek (telithromycin) was advertised by maker Sanofi-Aventis as having the most successful launch of any antibiotic in history. Yet it almost did not receive FDA approval. Seven months after Ketek finally received FDA approval, the antibiotic claimed its first death: a patient given Ketek for only a mild respiratory tract infection died from liver failure.

Since FDA approved Ketek in 2004, the drug medication has been linked to over 50 cases of liver failure and 5-10 Ketek-related deaths. Public hearings have been held since 2006 on whether Ketek should be subject to FDA recall, yet FDA has yet to recall Ketek and doctors continue to prescribe Ketek with over 5 million prescriptions written so far.

Ketek has been the subject of major controversy and an ongoing Congressional investigation into FDA recall and approval process. Ketek was originally prescribed to patients for a number of sinus and lung infections, including pneumonia caused by resistant strep infections. FDA has since removed two approved uses (treatment of acute bacterial sinusitis and acute exacerbation of chronic bronchitis) from its safe list of indications and has added a black box warning (FDA’s strongest safety warning) after researchers have found that Ketek was 3.5-11 times more likely to cause acute liver failure than other antibiotics already on the market. Ketek should never be prescribed to a patient with myasthenia gravis (a type of autoimmune disorder).

Ketek’s Questionable FDA History

FDA fast-track approved in 2004, a dark history lurks behind Ketek’s approval. Severe liver damage from Ketek has led investigators and whistleblowers to make public the questionable medical research behind Ketek’s approval.

Senate investigations into FDA’s approval of Ketek have revealed that FDA officials did not take the appropriate measures in investigating the merits of the drug up for approval and that Sanofi-Aventis, makers of Ketek, had perverted science to get their drug to approved.

Most antibiotics run the risk of causing liver damage, though those currently on the market have a significantly lower risk than Ketek. In a rush to get its new drug Ketek to market, Sanofi-Aventis paid doctors as much as $400 per patient enrolled in its Ketek safety study, allegedly to cover the costs of recruiting and gathering research data for them. This money-incentive proved too enticing for many physicians. Some doctors fabricated their Ketek research, inventing patients who were never given Ketek (one such doctor is spending the next 5 years in federal prison for her actions). Some doctors enrolled real patients but patients who did not need Ketek. Other doctors enrolled more patients than allowed by FDA standards, thereby skewing the study results and making Ketek appear safer than it is. Out of those later investigated, 4 out of 10 doctors conducting tests for Ketek were referred for criminal investigation. But these investigations came too late: Ketek had already been fast-track approved and was being prescribed to patients across the country.

Ketek Liver Damage and Money Recoveries for Injured Victims

Ketek received a black box warning in February 2007, FDA’s strictest warning before a FDA drug recall that would remove Ketek from market. FDA reports that Ketek can cause hepatic toxicity or serious liver injury, liver failure, and even death. Signs of liver failure include loss of appetite, jaundice, nausea, fatigue, and discoloration of urine.

Liver failure and injury are serious medical conditions. Often treatment requires long stays in the ICU. Some patients injured by Ketek have required liver transplants, a costly and dangerous medical procedure that causes death for one of ten patients.

Consumer Justice Group lawyers understand the hardships and betrayal of trust caused by Ketek injuries. We work to recover losses for patients injured by Ketek, including injuries related to the physical pain suffered, medical expenses incurred, and loss of wages/earnings from taking this dangerous drug medication FDA officials still have not recalled.