Muraglitazar - Another "Vioxx" Heading for the Market?

Pargluva (muraglitazar) is a new medication for diabetes awaiting approval by FDA. According to Steven Nissen and Eric Topol from the Cleveland Clinic, the new drug doubles the risk for heart attack, stroke and CHF (JAMA).

This month the FDA issued an "approvable letter" for the drug, meaning that muraglitazar could be approved once the agency received additional information.

The regular readers of medical journals probably remember that Eric Topol was the first one to raise doubts about the safety of Vioxx (JAMA). He also expressed concerns about the validity of Natrecor use in CHF patients (NEJM). Is Dr. Topol "anti-pharma" or just "pro-patient safety"? In any case, Eric Topol is among the top 20 most-cited scientists in the medical literature and his opinion certainly deserves the attention of the FDA.


Update 5/18/06:

Bristol-Myers Squibb discontinued the development of muraglitazar.


References:
Cardiologist goes toe to toe with drug companies - CNN
New Diabetes Drug Poses Danger to Patients, Cardiologists Say - Yahoo News
Effect of Muraglitazar on Death and Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes Mellitus - JAMA
Selling Safety - —Lessons From Muraglitazar - JAMA
New Diabetes Drug May Triple Death Risk - WebMD
Failing the Public Health — Rofecoxib, Merck, and the FDA - NEJM


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A BlackBerry Thumb - AP

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Transpanting 4 organs from a donor infected with WNV left 4 patients in critical condition.

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Chronic trauma on the arteries and nerves in the perineum has adverse sexual effects in both men and women.
Source: Serious Riders, Your Bicycle Seat May Affect Your Love Life - NYT