Ketek - (Telithromycin)

After 9 deaths, the FDA recommends “Black box warning” for Ketek

You may have recently heard about the health dangers associated with the use of the drug Ketek (telithromycin), but the Food and Drug Administration and other watchdog organizations have been concerned for some time. Finally, after nine deaths, the FDA has recommended the strongest warning that can be put on any drug’s labeling, namely a “black box warning.”  But is it enough? Will it effectively address the circumstances of those already suffering from Ketek’s documented dangerous side effects?

If you’re experiencing any unusual symptoms that may be associated with the administration of Ketek, here are some things you need to know, brought to you by TheAttorneyStore.com and Robert A. Schwartz, managing attorney in charge of Mass Tort and Commercial Litigation.

Why Ketek is prescribed?
According to www.ketek.com/patient/home.aspx, the website of Sanofi-aventis, makers of the drug, Ketek was approved April 1, 2004 for various therapeutic uses including:

ACUTE BACTERIAL SINUSITIS (ABS) involving the following symptoms that last longer than 10 days: sneezing; runny nose that won't go away; postnasal drip; facial pain.

ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (AECB) involving the following symptoms: increased shortness of breath; increased cough; increased sputum production; chills; generally feeling tired and sluggish; frequent respiratory infections.

COMMUNITY-ACQUIRED PNEUMONIA (CAP) involving the following symptoms: fever; cough, sometimes with phlegm; shortness of breath; chest pain or discomfort.
 
However, on Dec. 15, 2006, an FDA advisory panel determined that the risks of the controversial antibiotic Ketek outweighed its benefits for minor illnesses, that Ketek should not be sold as a treatment for sinusitis or bronchitis, and that Ketek could still be used for mild to moderate pneumonia, but then only as a secondary alternative to other medicines.
 
Dangers
Annals of Internal Medicine on Jan. 20, 2006 published an article reporting that three patients who had taken Ketek tablets experienced severe liver toxicity, noting that other cases also had been reported. In response to this news, the article said, “the FDA is continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted,” adding that the FDA is working to understand better the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin .

The article, published online, laid out the following recommendations to patients and healthcare providers.

• Healthcare providers should monitor patients taking telithromycin for signs or symptoms of liver problems and discontinue the drug in patients who develop these signs or symptoms.
• Patients not experiencing side effects such as jaundice should continue taking the medicine unless told to stop by their healthcare provider.
• Patients who notice any yellowing of their eyes or skin or other problems such as blurry vision should contact their healthcare provider immediately.
• As with all antibiotics, telithromycin should only be used for infections caused by a susceptible microorganism. Because telithromycin is not effective in treating viral infections, patients taking it for this reason risk side effects without any benefit.

All three patients mentioned above developed jaundice and abnormal liver function. The article pointed out that one patient recovered, one required a transplant and one died. A laboratory examination of the livers of the latter two patients 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. While these patients were all treated by physicians in the same geographic area, the significance of this observation, the article said, was not clear.

Current warnings not enough
Six months later, on June 29, 2006, the FDA issued a news release stating that it had completed its safety assessment of Ketek, determining that more safety warnings must appear on the drug’s labeling. It also advised patients and healthcare providers to “be on the alert for signs and symptoms of liver problems. Patients experiencing such signs or symptoms should discontinue Ketek and seek medical evaluation, which may include tests for liver function.”

The New York Times weighed in heavily on the issue on Dec. 16, 2006, reporting on a federal advisory panel’s conclusion December 15, the previous day, that the risks in using Ketek outweigh the benefits for minor illnesses and that the drug “should not be sold to patients with sinusitis or bronchitis.”  The drug, which by mid-December had been singled out by the FDA as having attributed to nine deaths worldwide, could still be used to treat mild to moderate pneumonia, but it should be “a secondary alternative to other medicines (for this condition).”

Most of the 19-member advisory panel said that Ketek should carry what’s known as a “black box warning” – the strongest warning the FDA can require drug manufacturers to place on a product’s label. This warning for Ketek, the panel recommended, should address its potentially serious side effects such as liver failure, visual disturbances, loss of consciousness and serious aggravation of myasthenia gravis, a neuromuscular condition.

“I myself would not take that risk,” said advisory panel member Joan Hilton, associate professor of epidemiology and biostatistics at the University of California, San Francisco.

Predicting that the panel’s vote “could signal a virtual death knell for Ketek in the United States,” The New York Times said that nearly six million prescriptions have been written for Ketek since its approval in 2004, but sales of the drug dropped sharply earlier this year following the FDA’s raising of safety issues including possible liver toxicity. According to prescription data, 2006 sales of Ketek are down from $148 million in 2005.

It’s not new news
The sometimes-slow-moving FDA knew about health concerns surrounding Ketek long before all this. In 2001, the year after Sanofi-aventis first applied for Ketek approval, the FDA was already raising questions about liver problems associated with the drug. It even required an additional safety study before it would approve it.

The Times went on to report that following a previous Times story on an internal memo written by an FDA official questioning the safety of the drug, Sanofi-aventis announced in the spring of 2006 a pause in clinical trials of Ketek to treat ear infections and tonsillitis in children  “Shortly afterward,” the December 16 Times story said, “the F.D.A. [sic] warned that Ketek could cause liver problems, noting 110 adverse reports involving the drug, including 12 of liver failure and 23 involving serious liver injury.”

Surely Sanofi-aventis was aware of the documented harm its drug had caused to human beings. Yet the aggressiveness of the company to have Ketek on the market is clear in this statement made by former FDA medical officer Dr. David Ross, who testified against the drug at the Dec. 15 advisory panel hearing: “Management was so bent on approval that I was pressured to soften my review.”

In conclusion, the Times conceded that while liver problems have been associated with other antibiotics, “an F.D.A. [sic] analysis found that the rate of adverse reports with Ketek was higher.”  There was another antibiotic whose rate of adverse reports was higher than Ketek. That drug has been removed from the market. If you or a loved one has suffered any of the symptoms of liver damage listed below, you should contact your physician or healthcare provider immediately. If you are concerned about your legal rights, contact Robert A. Schwartz, at Bailey & Galyen .

SYMPTOMS OF LIVER DAMAGE can include any or all of the following: tiredness, body aches, loss of appetite, nausea, jaundice (yellow color of the skin and/or eyes), dark urine, light-colored stools, itchy skin and belly pains.

ROBERT A. SCHWARTZ
Executive Vice President
Managing Attorney - Houston
Attorney in Charge of Mass Tort and Commercial Litigation
Bailey & Galyen
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