Ketek: Legal Information and Lawsuits

Ketek (telithromycin) is an antibiotic used to treat bacterial respiratory infections affecting the lungs and sinuses. Specifically, the drug is helpful for patients with bronchitis and pneumonia. The U.S. Food and Drug Administration (FDA) approved Ketek in April 2004. Sanofi-Aventis manufactured and marketed this medication until its discontinuation in 2016.

This article explains the risks and side effects associated with Ketek. You’ll also find legal information and safety data involving the drug.

Drug companies must ensure their medications are safe to use and carry adequate warnings. If you’ve developed liver disease or another serious illness after using Ketek, you may be able to recover damages for your injuries. Contact a personal injury attorney near you to learn your legal rights and options.

Ketek and Severe Liver Disease

Experts have linked Ketek to reports of severe liver disease. In some cases, liver damage occurred or worsened rapidly after just a few doses of Ketek. Some patients taking Ketek experience liver failure and may even require a liver transplant.

Some of the symptoms of hepatitis include the following:

• Loss of appetite
• Stomach pains
• Fatigue
• Body aches
• Nausea
• Jaundice (yellow color of the skin and eyes)
• Dark urine
• Light-colored stools
• Itchy skin

If you notice any of these symptoms after your use of Ketek, contact your doctor immediately and stop using the medication.

Talk to your healthcare professional about other treatments before taking Ketek if you have myasthenia gravis. Stop taking Ketek and seek medical attention if you have myasthenia gravis and your symptoms worsen.

Side Effects Associated With Ketek

Ketek carries other side effects besides a heightened risk of liver failure and liver disease. These side effects may include:

• Diarrhea
• Upset stomach
• Headache
• Dizziness
• Vomiting
• Loose stools
• Changes in the ability to taste
• Blurred vision, double vision, and difficulty focusing

Some side effects can be severe. Call your doctor immediately if you experience any of the following symptoms:

• Fainting
• Rapid, irregular, or pounding heartbeat
• Extreme tiredness
• Rapid change in blood pressure
• Unusual bleeding or bruising
• Lack of energy
• Loss of appetite
• Pain in the upper right part of the stomach
• Yellowing of the skin or eyes
• Flu-like symptoms
• Hives
• Rash
• Itching
• Difficulty breathing or swallowing
• Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• Hoarseness

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 conduct further studies and submit the drug once these studies were complete.

The FDA Submits Ketek for Approval Again

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. This time, the FDA approved Ketek but restricted its use. Within four years, more than 50 Ketek patients would get sick or die from severe liver injuries.

Timeline of Ketek News and Research Updates

There have been many news stories regarding the drug’s safety. Some literature questioned the FDA’s approval of Ketek. Much of the criticism concerns the 3014 study and how the FDA based Ketek’s approval on the findings of this study. Given the fraud involved in this study, many argue the FDA should not have allowed its findings to influence the approval process.

Follow along for significant news stories related to Ketek’s approval and later safety concerns.

March 2016: Drugmakers Discontinue Ketek

In March 2016, the FDA announced that Sanofi Aventis would discontinue Ketek in the U.S. and Canada. 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 pull a defective drug from the market. A drugmaker rarely admits it took a drug off the market for safety reasons. 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 that Ketek threatened public health.

February 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 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 planned 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.

Sick From Ketek? Get Legal Help

If you or a loved one experiences any dangerous symptoms or unusual medical conditions while using Ketek, contact your doctor or other healthcare professional. They’ll check to see if you suffer from hepatotoxicity or other illnesses. Next, you may want to contact an attorney to see if you have a valid claim for a Ketek lawsuit.

FindLaw’s directory of product liability lawyers can connect you with qualified legal help near you. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with dangerous drug cases. Many law offices offer free case evaluations.