KETEK INFORMATION

The Nations Law Firm represents people who have been injured by dangerous medications, such as Ketek. If you or someone you know has used Ketek and has suffered from liver damage or other serious side effects, please contact our offices for a free consultation with one of our pharmaceutical attorneys.

KETEK ISSUES

• Antibiotic approved by the FDA in 2004 to treat certain respiratory infections
  
• Ketek has caused serious liver damage and liver failure in many patients
  
• At least 5 patients have died from using Ketek
  
• At least one patient has required a liver transplant after taking Ketek
  
• Ketek can cause life-threatening breathing difficulties in patients with myasthenia gravis. At least one person has already died from this
  
• Ketek can cause blurred vision, difficulty focusing, and double vision
  
• After 2 years on the market, the FDA had received 110 reports of liver problems resulting from Ketek use
  
• Liver failure and death can occur after only a few doses of Ketek
  
• Most of the people injured by Ketek were otherwise healthy

THE HISTORY AND USE OF KETEK

Ketek (telithromycin) is an antibiotic used to treat serious respiratory infections in adults. Specifically, it is used to treat acute bacterial sinusitis, bronchitis, and pneumonia. Manufactured by Sanofi-Aventis, Ketek was introduced on the market in April of 2004. It is an antibiotic of the ketolide class, the first antibiotic of this class to be approved by the FDA. It is currently distributed world-wide and is used extensively in the United States, Europe and Japan.

Getting FDA approval for Ketek wasn't without its obstacles. In February of 2000, the FDA denied the manufacturer's first application for approval due to evidence of serious side effects including liver damage, loss of consciousness and blurred vision. Following the first failed attempt at gaining FDA approval, the manufacturer conducted a clinical study to further assess the adverse effects of using Ketek. The results of this study were dismissed by the FDA as being completely unreliable due to numerous reporting errors, and even falsifications, and Ketek was once again rejected by the FDA. Oddly enough, when the FDA did finally approve Ketek in 2004, it did so based on that same study and the fact that the antibiotic had been used in other countries without major adverse consequences. But it is important to bear in mind that adverse events are underreported in the United States, and even more so in other countries. So, any analysis based on adverse events reported to the FDA (or its foreign counterpart) must be adjusted to reflect this.

If you or someone you know has taken Ketek and suffered from severe adverse reactions, please contact our offices for a free case evaluation by one of our experienced pharmaceutical attorneys.

DEVASTATING SIDE EFFECTS

Ketek has caused liver toxicity, liver failure and death in otherwise healthy people. Most medications have some side effects, but they are usually tolerable and outweighed by the benefits provided by the medication. Even in cases where the side effects are more severe, the benefits from the drug may still outweigh the risk. But that's not the case with Ketek. You shouldn't have to risk your life to treat a sinus infection. And that's exactly what is happening with Ketek users. Following are some of the severe side effects that have been reported in patients using Ketek:

• Blurred vision, difficulty focusing, double vision. Most reported cases have been mild to moderate, but some were severe. This is not a usual side effect for antibiotics.
  
• Severe liver injury. This can worsen rapidly and can occur after only a few doses of Ketek.
  
• Acute hepatic failure (liver failure). The patient may experience rapid decompensation.
  
• Worsening of symptoms, i.e. muscle weakness and difficulty breathing, in patients with myasthenia gravis (a neurological disorder). This has occured within a few hours after taking the first dose. There are reports of life-threatening breathing difficulties and one death.
  
• Death. There have been at least 4 reported deaths resulting from liver toxicity and 1 death from worsening of myasthenia gravis symptoms.

The adverse effects outlined above usually occur while the patient is taking Ketek or shortly after stopping the medication. They can occur after taking only a few doses. The toxic effects on the liver are often characterized by a rapid deterioration of the patient's condition.

REPORTS OF KETEK DEATHS AND INJURIES

On January 20, 2006, Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of Ketek. All three patients developed jaundice and abnormal liver function. One patient, a 46-year-old caucasian man, recovered after developing drug-induced hepatitis; the second patient, a 51-year-old caucasian woman, required a liver transplant; and the third patient, a 26-year-old Hispanic man, died two weeks after taking Ketek for five days. When the livers of the latter two patients were examined in the laboratory, they showed massive tissue death. These two patients had reported some alcohol use. All three patients had previously been healthy and were not using other prescription drugs. These patients were all treated by physicians in the North Carolina area. The significance of this observation, if any, is not clear. This information was reported to MedWatch, the drug safety monitoring program of the U.S. Food & Drug Administration (FDA).

That was not the first time the FDA had learned of the serious side effects of Ketek. In 2006, when Ketek had been on the market for a mere two years, the FDA had already received 110 reports of liver problems associated with Ketek use. Of these cases, 12 involved acute liver failure and 23 involved serious liver injury. Of the patients who suffered from liver failure, 4 out of 12 died and one required a liver transplant. Reportedly, one of the patients who died was a 49-year-old woman who only took two doses of Ketek before being hospitalized. According to the FDA, most of the adverse reactions occurred in otherwise healthy people. A safety review of Ketek revealed that Ketek causes liver failure almost four times as often as other antibiotics.

If you or someone you know has suffered severe side effects from using Ketek, please contact our offices for a free consultation with one of our pharmaceutical attorneys.

RESPONSE FROM THE FDA AND THE MANUFACTURER

When the FDA approved Ketek for use in the United States in April of 2004, they assessed the risk of liver injury as being similar to the risk from other antibiotics then on the market.

In June of 2005, one year after Ketek was approved, the FDA’s Office of Drug Safety completed a safety evaluation of the antibiotic. They looked at the adverse events associated with Ketek and concluded that there was no new information that would change their previous assessment of the hepatic risks, i.e. the risk of liver damage.

On January 20, 2006, the same day the article was published in the Annals of Internal Medicine, the FDA issued a public health advisory about the possible adverse effects from Ketek. While continuing its investigation of Ketek, the FDA provided the following recommendations to healthcare providers:

Healthcare providers should monitor patients taking telithromycin for signs or symptoms of liver problems. Telithromycin should be stopped in patients who develop signs or symptoms of liver problems.

Patients who have been prescribed telithromycin and are not experiencing side effects such as jaundice should continue taking their medicine as prescribed unless otherwise directed by their healthcare provider.

Patients who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare provider immediately.

As with all antibiotics, telithromycin should only be used for infections caused by a susceptible microorganism. Telithromycin is not effective in treating viral infections, so a patient with a viral infection should not receive telithromycin since they would be exposed to the risk of side effects without any benefit.

On January 27, 2006, the European Medicines Agency (EMEA) issued a safety statement regarding the risks of Ketek. Health Canada followed suit with a similar warning on February 7, 2006.

On June 29, 2006, the FDA issued its second Public Health Advisory about the dangers of Ketek. Having completed their safety assessment, the FDA concluded that

... the drugs' benefit to patients for the approved indications outweighs its risk, including the rare risk of liver failure, and supports its continued availability.

Although Ketek will remain on the market, the FDA did conclude that additional warnings are required on the drug's labeling to address the risk of liver toxicity and to strengthen the warning for patients with myasthenia gravis. The manufacturer revised the labeling in June of 2006 in accordance with the FDA's request.

The FDA now offers the following recommendations for taking and prescribing Ketek:

"We are advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems," said Dr. Steven Galson, Director for FDA's Center for Drug Evaluation and Research. "Patients experiencing such signs or symptoms should discontinue Ketek and seek medical evaluation, which may include tests for liver function."

The manufacturer has now included the FDA-mandated warnings in its revised label for Ketek. But it's important to note that this is not a "black box" warning. The FDA has different types of warnings for medication labels. A black box warning is the strongest as it is very prominently displayed in a black box at the beginning of the label. The warnings that were added to the Ketek label are buried in various places throughout the 28-page label. Whether or not that will suffice as an effective warning remains to be seen.

If you take Ketek, be on the lookout for any signs or symptoms of liver injury, i.e. fatigue, malaise, loss of appetite, nausea, yellow skin and/or eyes, dark-colored urine, or tender abdomen. Seek medical attention immediately should you experience any of these symptoms. If you or someone you know has taken Ketek and suffered from liver injury or other serious adverse effects, please contact our offices for a free consultation with one of our pharmaceutical attorneys.

LEGAL RECOURSE

Our law firm represents people across the country who have been injured by Ketek and other dangerous medications. Pharmaceutical companies owe a moral and legal responsibility to the public to ensure that the medications they manufacture and market are not unreasonably dangerous and to ensure that the consumer is made aware of the risks associated with the medication. The business of pharmaceuticals in the United States is highly competitive and is worth billions of dollars. Unfortunately, some pharmaceutical companies are hastily introducing and marketing new drugs prematurely and without adequate warnings, resulting in tragic losses that could have been avoided.

If you or someone you know has used Ketek and has suffered from liver damage or other serious side effects, please contact our offices for a free case evaluation.