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troglitazone (REZULIN)

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    However, drug company websites are not the only, and certainly not the best, place to find unpublished data on drugs. Consulting readily available US governmental sources on the internet can lead to different conclusions regarding drug safety and efficacy. Using FDA data sources, we have just completed our own assessment of the thiazolinediones.
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    It is urgent for you and other leaders in HHS--and all government agencies--to re-read and strongly urge the implementation and enforcement of a 1958 Congressional Resolution entitled The Code of Ethics for Government Service (175 72 Stat B12, 1958) which states that "Any person in Government Service should put loyalty to the highest moral principles and to country above loyalty to persons, party or Government department."
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    This letter is to request the opening of a criminal investigation of Warner-Lambert/Parke-Davis for what appears to be illegally delaying the submission of a compilation of data known to the company before marketing had begun--clearly showing troglitazone-induced liver toxicity--until after the drug was marketed.
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    Class efficacy issues include the lack of efficacy compared to previously available drugs, sulfonylureas, and the deterioration of blood sugar levels when patients are switched from other oral anti-diabetic drugs to the glitazones. Safety issues include liver toxicity, effects on heart function, weight gain, edema, anemia, low blood pressure, elevated lipid levels, and possible changes in progesterone levels.
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    Letters-Science by Peter Lurie, M.D., M.P.H. Larry Sasich, Pharm.D., M.P.H. Letter to the Editor in the Journal of the American Medical Association in response to an article on the safety of Food and Drug Administration approved drugs which were withdrawn
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    John Doe was an otherwise healthy 45 year old Washington D.C. policeman who was started on Rezulin in the late summer of 1998, preceded by perfectly normal liver tests. Within a week after he started taking the drug, well before he was due for another liver test, he became seriously ill, was hospitalized at Johns Hopkins with acute liver failure.
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    Enclosed is an extremely misleading direct-to-consumer (DTC) advertisement that lacks fair balance for the dangerous diabetes drug troglitazone (Rezulin), made by Parke Davis, a division of Warner Lambert, of Morris Plains, NJ. This ad, with the good news and promotional information in Spanish but the official labeling with warnings and risks in English
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    We have obtained information from the FDA that as of June 5, 1998, there had been at least 21 deaths from liver failure and three patients requiring liver transplants caused by the recently-approved diabetes drug, troglitazone (Rezulin-Parke- Davis/Warner Lambert).

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