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KETEK NEWS

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.

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FDA WARNS DRUG COMPANY FOR FAILING TO ACT ON KETEK FRAUD

Clinical Investigators accused of submitting tainted Ketek data

By Cindy L. Nations
October 26, 2007

This week the FDA sent a 9-page Warning Letter to drug company Sanofi-Aventis notifying them of "objectionable conditions" found during an FDA investigation into Ketek clinical studies. The drug company was accused of knowingly submitting clinical drug study data that was obtained by investigators who had committed "multiple and significant violations of FDA regulations ... that affected the integrity of data submitted." The warning letter gives Sanofi-Aventis 15 days to provide the FDA with a written response addressing the list of deficiencies and says, "FDA also plans to meet with your company."

See the FDA Warning Letter (PDF format)

More information on Ketek

Source: Law Offices of Howard L. Nations
www.howardnations.com

FDA SAFETY ALERT

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152681.htm

Source: U.S. Food & Drug Administration
February 12, 2007

FDA PRESS RELEASE

FDA Announces Label and Indication Changes for the Antibiotic Ketek

The Food and Drug Administration (FDA) today announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use of Ketek by patients. The changes include the removal of two of the three previously approved indications -- acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis -- from the drug's label. (More on changes for Ketek...)

Source: U.S. Food & Drug Administration
February 12, 2007

KETEK DRUG INFORMATION PAGE

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107824.htm

Source: U.S. Food & Drug Administration
February 12, 2007

FDA Public Health Advisory on Ketek (telithromycin) 01/20/2006

January 20, 2006

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150628.htm

FDA Questions & Answers about Ketek

February 12 , 2007

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107826.htm

Brief Communication: Severe Hepatotoxicity of Telithromycin: Three Case Reports and Literature Review

Kimberly D. Clay, MD, MPH; John S. Hanson, MD; Scott D. Pope, PharmD; Richard W. Rissmiller, MD; Preston P. Purdum III, MD; and Peter M. Banks, MD