Ketek By the Numbers
2—Times the Food and Drug Administration declined to approve Ketek due to safety concerns before it finally won approval in April 2004.
5—Of six authors of positive article about Ketek in April 2006 issue of New England Journal of Medicine had received funding from Sanofi-Aventis; sixth was actually an employee of the French pharmaceutical giant.
6—Most serious side effects of Ketek: headache, dizziness, alteration in taste, loss of appetite, nausea, vomiting, constipation, diarrhea and jaundice and hepatitis (inflammation of the liver).
7—Common side effects of Ketek: difficulty sleeping, nervousness, double vision, severe muscle pain or weakness, rash, palpitations, arrhythmias of the heart and temporary loss of consciousness.
9—Months after Ketek’s approval by the FDA, four patients suffer serious liver failure after using the drug.
12—Cases of acute liver failure (and four deaths) attributed to use of Ketek.
100-plus—Patients who had suffered adverse renal events while taking Ketek, as of November 2006.
4,000—Children (from 6 months to 13 years in age) in 12 countries in Sanofi-Aventis’ clinical trial to determine effectiveness of Ketek in treating ear infections and tonsillitis. The FDA urges the company to halt the trial due to potential health risks to kids.
25,000—Participants in clinical study Sanofi-Aventis used to gain FDA approval of Ketek in 2004; the agency later found parts of that study to be fraudulent.
5.6 million—Prescriptions written for Ketek since 2004.
$200 million—Sanofi-Aventis’ sales of Ketek in 2005.