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US Health Care System

Ketek

Project: US Health Care System
Open-Content project managed by kuhan, mtuck

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In a 7 to 3 vote, an FDA advisory panel recommends approving the antibiotic Ketek, also known as telithromycin, for use in treating streptococcus pneumonia. But the panel does not recommend approving it for use against acute chronic bronchitis, sinusitis, or penicillin-resistant or erythromycin-resistant strep. The panel also recommends conducting additional clinical trials to “see if hints of concern… are real or not” about the drug’s potential side affects on the heart and liver. [Associated Press, 4/26/2001]

Category Tags: Ketek

The FDA informs Aventis that it will not approve the drug Ketek until the company has provided enough information to determine the drug’s safety profile. [Aventis, 6/4/2001] In April, an FDA advisory board recommended additional clinical studies for the drug because of concerns about potential side effects on the heart and liver (see April 26, 2001).

Entity Tags: Aventis, US Food and Drug Administration

Category Tags: Ketek

Aventis contracts Pharmaceutical Product Development, Inc. to do a clinical trial for Ketek, an antibiotic designed to treat respiratory infections. The trial, named “Study 3014,” is being done because of FDA concerns (see Early June 2001) about possible links to heart and liver problems. The company pays doctors $400 for each patient they enroll in the study. Some of the doctors—a bit overzealous in recruiting patients—forge signatures, sign up family members, and invite patients into the study who do not have infections. There are also problems with the way some of the doctors collect and record their data. One doctor, who enrolls 251 patients, does not follow the study’s instructions and fails to report adverse drug reactions. Another physician, Dr. Maria Anne Kirkman-Campbell, who runs a weight-loss clinic, signs up 407 patients—but only 10 percent of them actually take the drug. These problems are discovered by FDA inspectors in fall 2002. [ABC, 1/14/2006; Wall Street Journal, 5/1/2006 pdf file]

Entity Tags: Pharmaceutical Product Development, Inc., Aventis, Maria Anne Kirkman-Campbell

Category Tags: Ketek

After reviewing results of clinical study 3014 for the antibiotic Ketek, an FDA advisory panel recommends that the drug be approved. [Aventis, 1/9/2003] The panel makes the decision completely unaware that the FDA had discovered problems with the study only a few months before. [ABC, 1/14/2006; Wall Street Journal, 5/1/2006 pdf file] In October, an FDA examiner found that some doctors were reporting fraudulent results. For example, some doctors had failed to record the data properly while others had invited patients into the study who did not meet the necessary qualifications. In one case, several patients who were enrolled in the study were not actually taking the drug (see October 2001-Fall 2002).

Entity Tags: US Food and Drug Administration

Category Tags: Clinical drug studies, Ketek

Aventis announces that the FDA has again declined to approve the company’s antibiotic drug Ketek, citing the need for additional analyses and information pertaining to Study 3014 (see October 2001-Fall 2002). [Aventis, 1/27/2003]

Entity Tags: Aventis, US Food and Drug Administration

Category Tags: Ketek

April 1, 2004: FDA Approves Ketek

The FDA approves the drug Ketek for treatment of chronic bronchitis, acute bacterial sinusitis, and community-acquired pneumonia in patients age 18 and older. [Aventis, 4/1/2004] The approval decision is made despite evidence that a 2001-2002 clinical trial for the drug, study 3014, was replete with fraudulent data (see October 2001-Fall 2002). The FDA says the approval is based on data submitted in 2000, other studies, and the drug’s safety record overseas where the drug has been in use for several years. [Wall Street Journal, 5/1/2006 pdf file]

Entity Tags: Aventis, US Food and Drug Administration

Category Tags: Ketek

The Annals of Internal Medicine posts an “early release” version of an article reporting three cases of acute liver failure in previously healthy patients who had taken Ketek. [Los Angeles Times, 6/17/2006] The final version of the article will be published in late March. [Clay et al., 3/21/2006] The FDA, responding to the new data, insists the drug presents no more danger to the liver than other antibiotics. The agency even cites the results of Study 3013, which FDA investigators previously determined relied upon fraudulent data (see October 2001-Fall 2002 and March 25, 2004). [Wall Street Journal, 5/1/2006 pdf file]

Entity Tags: US Food and Drug Administration

Category Tags: Ketek

In a memo, FDA safety investigators warn that the link between Ketek and liver damage could be more serious than a recent study published in the Annal of Internal Medicine suggested (see January 2006). The memo says there have been 12 cases of liver failure among Ketek patients, including one patient who took only one dose of the medication. Four patients are known to have died, and one had to undergo a liver transplant. They suffered a “profound degree” of liver damage, the memo says. “The rapid tempo and severity of injuries… suggest an acute hypersensitivity-like process.” A review of data on three similar drugs showed far fewer incidents of liver failure, according to the memo. [Los Angeles Times, 6/17/2006]

Entity Tags: US Food and Drug Administration

Category Tags: Ketek

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