Post-marketing adverse drug experiences

Based on their pharmacokinetic profile alone, the safest statins in chronic compensated liver disease and a history of decompensation are prohahly pravastatin and rosnvastatin. However, clinical experience with rosnvastatin in liver disease is lacking, and so it cannot be recommended. In addition, the true rate of post-marketing adverse drug reactions is not yet clear. Pravastatin is therefore the drug of choice in these patients, where treatment is deemed necessary. It should, however, be avoided in acute episodes until liver function or transaminases stabilise/return to normal. 

See also CFR Web site, http //www.access.gpo.gov/nara/cfr/index.html. An August 1997 guideline, Post-Marketing Adverse Experience Reporting for Human Drug and Licensed Biological Products Clarification of What to Report, defined the minimum data relevant for a safety report as... 

FDA 21 CFR Part 600.80. Post-marketing reporting of adverse drug experiences. Federal Register 1997 62 52252-52253. 

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