Medwatch Reports...Lipitor® 1998 - 2007

By Duane Graveline MD MPH

Objective: What prompted me to do this personal search of what most would agree is FDA's business is the almost total lack of awareness in the medical community of the many cases of cognitive dysfunction, severe emotional and behavioral disorders and disabling neuro-muscular degeneration associated with the use of statin drugs. I knew that thousands of reports of these conditions had gone into Medwatch. What is wrong with the ADR reporting system, I wondered, that the medical community seems unaware of these reports of statin damage?

Methods: I gained access to a CD of actual Lipitor Medwatch data from the period Nov 1997 to early 2007. Using the usual PC search mechanism, it was technically straight-forward to count out numbers of case reports for each search term I entered.

Results: The numbers of case reports for such search terms as severe cognitive dysfunction (662), neuropathy (547), rhabdomyolysis (1592) , Depression (517), unusual weakness (1158) and hepatitis (951) during the reporting period are particularly impressive to most MDs when weighed against their awareness that the true incidence of side effect reporting may be ten to one hundred times the reported incidence.

Conclusions: There is reason to suspect that because of unreliable FDA reporting of significant Medwatch data, the medical community has been grossly misled as to the true magnitude of the statin drug side effect problem........................

http://www.spacedoc.net/medwatch_lipitor.html


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