Ketek Information
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Antibiotic Ketek Linked to Severe Liver Injury, Including Jaundice, Hepatitis and Liver Failure
On January 20, 2006, researchers reported three cases of severe liver toxicity following the use of Ketek. Of these cases, one patient needed a liver transplant and another died. Examination of these patients' livers showed massive tissue death. All patients had been healthy previous to the use of Ketek.
Ketek, known generically as telithromycin, is an antibiotic used for the treatment of respiratory infections including chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. Ketek is manufactured by the French pharmaceutical giant Sanofi-Aventis.
Three cases of liver toxicity were reported to FDA MedWatch and reported in an article in the Annals of Internal Medicine. Of these cases, one patient recovered, one patient needed a liver transplant and the other died. Examination of these patients' livers showed massive tissue death. All patients had been healthy previous to the use of Ketek and were not using other prescription drugs. The two latter patients had reported some alcohol use.
Regrettably, this is not the first chapter in the Ketek saga. The initial new drug application for telithromycin was rejected by the FDA in June, 2001, citing a request for additional safety data regarding liver injuries, blurred vision, and other possible side effects. Based on these concerns, the FDA ordered Sanofi to conduct further safety tests. In October, 2001, the company started Study 3014, which proved to be an appalling disaster.
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The physician who recruited the largest number of subjects (414, at $400 each according to the contract introduced in evidence at her trial) is in federal prison after pleading guilty to fraud resulting from the fabrication of data. Internal corporate documents reviewed by The Wall Street Journal indicate the company’s concern with its highest recruiter, but the concerns were not disclosed to the FDA, which uncovered the problems independently. The second-high enroller (251 patients) was found during an FDA audit to have not followed the protocol or reported adverse drug reactions; he admitted in an interview with The Wall Street Journal to never having participated in a study before. The third-highest recruiter (214 patients) was at the time of study accrual working with a probationary license under sanction of a state disciplinary board; the FDA audit found evidence of records altered with “white-out.” This same doctor was later arrested for threatening to kill his wife, after being found at his home with a loaded handgun and cocaine in his underwear.
What is perhaps most outrageous about the entire sad affair is that Study 3014 was specifically mandated to investigate liver toxicity. Now, after being on the market for two years, there is new evidence that Ketek is harmful to the liver. A recent analysis of the FDA’s post-marketing database showed that the rate of reporting of acute liver failure was 3.5 to 11 times as high for Ketek as for other antibiotics, with a reporting rate of 167 cases of acute liver failure per 1 million person years of telithromycin use, as compared with the expected rate of 1 case per 1 million person-years.
If you or a loved one has suffered a reaction to Ketek (including jaundice, hepatitis, cirrhosis or liver faulure) which required hospitalzation, please contact the Levin, Papantonio law firm by completing this short case evaluation form for a free evaluation of your potential claim.
Ketek News and updates
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FDA: Ketek Safety Alert
The Food and Drug Administration notified healthcare professionals and patients that it completed its safety assessment of Ketek (telithromycin), indicated for the treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis and community acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections. The drug has been associated with rare cases of serious liver injury and liver failure with four reported deaths and one liver transplant after the administration of the drug. FDA determined that additional warnings are required and the manufacturer is revising the drug labeling to address this safety concern. FDA is advising both patients taking Ketek and their doctors 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.
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- Sanofi's Ketek side-effect warning strengthened by European
ABCmoney.co.uk, UK - Mar 30, 2007
... the group's Ketek antibiotic, prohibiting its use for patients with a rare auto-immune disease and giving a 'strengthened warning' of other side effects...
- Letter Outlines Revised Labeling for Ketek
Facts and Comparisons, MO - Mar 28, 2007
Sanofi-Aventis has issued a letter to health care professionals notifying them of revised labeling for Ketek (telithromycin) that includes a boxed warning ...
- Replidyne needs more faropenem studies
BusinessWeek - Mar 27, 2007
The company halted a late-stage study on the drug in December to consider excluding the comparison to another antibiotic, Ketek. An FDA committee has said ...
- FDA chief defends agency openness
Scientific American - Mar 23, 2007
Concerns over drug safety were renewed after Sanofi's antibiotic Ketek was linked to liver failure. In February, the FDA revoked the drug's approval for ...
- Watchdogs should be concerned with consumers' best interests
Gainesville Sun - Mar 18, 2007
What good is a watchdog that befriends T-bone-toting trespassers? The U.S. Food and Drug Administration (FDA) is our watchdog. It should ensure that our foods and drugs are safe - or at least that labels warn us about health risks. ...
- Lawmakers blast FDA for censorship, negligence regarding unsafe drugs
NewsTarget.com - Mar 16, 2007
Top U.S. lawmakers at a recent hearing criticized the FDA for drug safety problems. The hearing focused on the FDA's handling of a Sanofi-Aventis antibiotic, called Ketek, and several prescription anti-depressants. Problems with these drugs, and also Merck's now-withdrawn Vioxx, were cited. ...
- Industry Insider: Senator spars with FDA chief over whistle-blower remarks
The Star-Ledger - Mar 14, 2007
A vocal Senate critic of the Food and Drug Administration took issue this week with the agency's commissioner, saying he may be trying to prevent employees from raising concerns about drug safety and other issues to Congress. ...
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Embattled FDA chief fights back
Houston Chronicle, TX - Mar 3, 2007
The agency also restricted the use of Ketek for treatment of pneumonia. The administration has proposed adding $10 million in next year's budget for more ...
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FDA Drug Approval Process under Scrutiny
OMB Watch - Feb 22, 2007
The testimony of Dr. David B. Ross, a physician and former FDA pharmaceutical reviewer, told the story of the antibiotic Ketek. Dr. Ross claimed Ketek was ...
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Ketek case keeps glare on reform
Trenton Times, NJ - Feb 14, 2007
WASHINGTON--The Food and Drug Administration's missteps in approving the controversial antibiotic Ketek were cited at a congressional hearing yesterday as ...
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FDA Limits Use of Antibiotic After 4 Deaths
International News Service, Australia - Feb 13, 2007
The Food and Drug Administration announced serious restrictions yesterday on the antibiotic Ketek -- after reports of four deaths and rare but serious ...
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Lawmakers blast FDA drug safety oversight
Reuters - Feb 13, 2007
They cited problems with Sanofi's antibiotic, Ketek, Merck & Co. Inc.'s withdrawn arthritis drug Vioxx and antidepressants made by several companies. ...
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Earthtimes.org - Feb 12, 2007
12 The US Food and Drug Administration ordered revised labeling for the antibiotic Ketek (telithromycin) to improve the safe use of the drug. ...
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Times Record News, TX - Feb 12, 2007
The Food and Drug Administration said the antibiotic, Ketek, would remain on the market but that its label will bear a new, stern warning. ...
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Bloomberg - Feb 8, 2007
The scientists include David Ross, who said in an interview that FDA supervisors forced him to retract a recommendation that the antibiotic Ketek, ...
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Antibiotic drug linked to liver damage
PakTribune.com, Pakistan - Jan 25, 2007
Doctors at the Carolinas Medical Center in Charlotte, North Carolina, studied three patients who were administered the drug 'Ketek' and found liver failure ...
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Replidyne stops bronchitis drug trial
Dec. 26, 2006
... dummy drug and Ketek, an antibiotic by Sanofi-Aventis. The trial was ... consider exclusion of Ketek from the study, the company said in a ... additional comparison to Ketek was primarily for "commercial competitive.
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Advisers Suggest Restricting Antibiotic
Dec. 15, 2006 | Andrew Bridges Associated Press Writer
... drug, called Ketek, to exclude the treatment of the two lesser infections ... experts to discuss Ketek in light of concerns about its safety. An agency ... 3 to say Ketek's benefits outweigh its risks in treating pneumonia. In 17 ...
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FDA panel urges limits on Sanofi antibiotic
Dec. 15, 2006 | Lisa Richwine
... - Sanofi-Aventis antibiotic Ketek should stay on the market but use ... to keep selling Ketek for pneumonia but be barred from promoting the ... said doctors needed Ketek as an option for treating pneumonia, which ...
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FDA to Assess Antibiotic Linked to Woes
Dec. 14, 2006
... the drug, Ketek, through September. Doctors have prescribed the ... handling of Ketek remains under investigation by a Senate committee. ...
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FDA, Lawmaker Clash Over Antibiotic
Nov. 30, 2006
... the information about Ketek could have a chilling effect on the FDA's ... 's handling of Ketek, which has been linked to severe liver problems and ... Grassley said. Ketek is made by the French pharmaceutical company ...
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