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KETEK MAY CAUSE LIVER FAILURE
by Jane Mundy
The prescription antibiotic drug Ketek (known generically as telithromycin) was given a black box warning in February 2007 after many reports linked the drug to adverse side effects, including liver failure and even death.
Since its approval in 2004, Ketek had been used to treat bacterial infections in the sinuses and lungs, including chronic bronchitis and pneumonia. But the Food and Drug Administration (FDA) has now approved Ketek only for the treatment of mild to moderate cases of pneumonia acquired outside hospitals or long-term care facilities.
Although an FDA advisory panel recommended that Ketek be given a black box warning in December 2006, the recommendations were not binding. Sanofi-Aventis, the manufacturer of Ketek, received warnings as far back as April of 2004 that patients had suffered liver failure after taking the drug. Even with this knowledge, the drug was continually prescribed to millions of people for sinus infections.
In a memo by the FDA's Division of Drug Risk Evaluation and published by The Wall Street Journal (May 19, 2006) an identifiable link was found between Ketek and liver failure. Furthermore, the memo also stated that from April 2004 through April of 2006, at least 23 patients suffered serious liver injury, including 12 liver failures cases, as well as 44 patients who experienced less severe liver problems. It went on to say that patients experienced liver problems within a few days after taking the drug.
Finally in December of last year, the FDA finally began investigating these and other reports linking Ketek to liver failure and determined 53 cases of liver failure and five deaths were caused by the antibiotic.
Then in April, 2007 the New England Journal of Medicine accused the FDA of approving Ketek “entirely on the basis of noninferiority trials”. It stated that the agency’s approval of Ketek was a process “marked by fraudulent data, use of uncontrolled safety reports, and reliance on improperly conducted trials”.
In its clinical trials, Sanofi-Aventis signed up 1800 doctors who would be given $400 for every patient that agreed to participate and take Ketek. The FDA later conducted an audit and found serious flaws in the study. One doctor was convicted of fraud and received a prison sentence: her entire staff was registered in the trial. The FDA found discrepancies at numerous other sites, including forged patient signatures.
Despite this, the FDA stood by its decision to approve Ketek.
Currently, U.S. authorities are conducting an investigation of Ketek and the FDA is under fire for its drug-approval process.
If you have taken Ketek, contact your doctor immediately if you have developed liver damage; jaundice, drowsiness; dizziness;blurred vision or double vision; or nausea.
Any symptoms of liver damage should not be ignored. If you have developed any of the above symptoms, or you have lost a loved one who was taking this drug, you may want to contact a Ketek attorney who will review your case at no charge.
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