Ketek: History and News

Ketek (telithromycin) is an antibiotic doctors prescribe to patients with infections of the lungs and sinuses. Common ailments this medication treats include bronchitis and pneumonia. This prescription drug has existed since its Food and Drug Administration (FDA) approval in 2004.

People taking Ketek have reported vision problems and other serious side effects. A small percentage of Ketek patients also reported experiencing severe liver damage after using the drug.

Here, we'll offer a brief history of the drug. We'll also discuss some of the issues surrounding Ketek over the years.

Sanofi-Aventis Submits Ketek for FDA Approval

Before a drug manufacturer can release a new medication, it must submit the drug to the FDA for approval. Sanofi-Aventis, the company that manufactures Ketek, first submitted the drug to the FDA in 2000.

During the FDA's first review of Ketek, the agency found several safety issues. According to a 2007 article in the New England Journal of Medicine, these issues included the following:

• Clinical trials found there were too many adverse drug reactions
• There were visual acuity issues with the drug
• The medication caused hepatocellular hepatitis
• The drug's problems were similar to those in other drugs the FDA has recalled

The FDA told Sanofi-Aventis to do further studies and submit the drug once these studies were complete.

The drugmaker submitted Ketek to the FDA a second time in 2002. This was after the company had done its "3014 study." This study allegedly addressed the issues the FDA raised in its initial drug review.

When Sanofi-Aventis submitted the drug a second time, it was already aware of serious safety issues with Ketek. Some doctors who participated in the 3014 study fabricated patient enrollment information. The FDA would later start criminal investigations into several of these doctors. The courts would also sentence one doctor to 57 months in prison for fraud.

During this second review, the drug company notified the FDA of the fraud. The FDA managers still voted to approve the drug 11-1.

In 2003, Sanofi submitted Ketek again for FDA approval. The FDA would eventually approve the drug but restricted its use. Within four years, more than 50 Ketek patients would get sick or die from severe liver injuries.

Ketek in the News

There have been many news stories about Ketek's safety. The literature has questioned the FDA's approval of the drug. Much of the criticism concerns the 3014 study and that the FDA based its approval of Ketek on the findings of this study. Given the fraud involved in this study, many argue that the FDA should not have let its findings cloud their judgment during the approval process.

What follows are news stories related to Ketek's approval and later safety concerns involving the drug.

March 11, 2016: Drugmakers Discontinue Ketek

In March 2016, the FDA announced that Sanofi Aventis would discontinue the manufacture and sale of Ketek. This included the 300 mg and 400 mg tablets. The company said it was discontinuing the drug for business reasons.

It's common for pharmaceutical companies to claim business reasons when they drop a defective drug. A drugmaker rarely admits it took a drug off the market for safety reasons. This is why Sanofi Aventis did not acknowledge that its drug caused acute liver failure.

The FDA announcement didn't mention the Ketek-related deaths and injuries. Nor did it reference the fact that Ketek threatened public health.

The drugmaker also discontinued the drug in Canada.

Feb. 12, 2007: FDA Warns of Ketek Use Risks

In February 2007, the FDA announced that doctors should not prescribe the antibiotic Ketek to treat sinusitis and bronchitis. According to the FDA, healthcare providers should restrict drug use for patients suffering from community-acquired pneumonia. This was due to the severe adverse events patients reported to the FDA. The FDA had previously approved Ketek for treating chronic bronchitis and other respiratory tract infections.

The agency also ordered Ketek's manufacturers to update their labels with a black box warning. These new warnings were to address the drug's side effects — specifically the severe liver problems. They were also to warn Ketek patients with myasthenia gravis not to use the drug.

June 29, 2006: FDA Completes Safety Assessment of Ketek

In June 2006, the FDA notified healthcare professionals and patients that it had completed its safety assessment of Ketek. According to the governmental agency, Ketek caused rare cases of serious liver injury and liver failure. The 2006 alert reported four patient deaths and one liver transplant. Although the FDA concluded that Ketek's benefits outweighed its risks, it determined that the pharmaceutical company needed to change its warning labels.

2006: Disgruntled FDA Managers and Ketek Safety Concerns

In March 2006, one of the managing doctors at the FDA suggested the makers of Ketek suspend a study planning to test Ketek use on infants and children. Given the risk of liver injuries and liver failure, the manager didn't feel the benefits of the proposed study were significant enough to risk injury to the 4,000 participants. Another FDA manager disagreed with him.

FDA Commissioner Dr. Andrew von Eschenbach told the two doctors they were not to speak of their disagreement outside the agency. The commissioner told the two managers he would fire or reassign them if they spoke of their concerns to the public or other parties.

What To Do if You Became Sick After Taking Ketek

If you or a loved one developed a liver injury after taking Ketek or any dangerous drug, you have options. Speak with an experienced personal injury attorney to see if you have a valid claim for a Ketek lawsuit.