René Belder, MD

5/22/02


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Table of Contents

René Belder, MD

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Pravachol Extensive Worldwide Safety Experience

Special Safety Considerations For OTC Use

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Pravachol: No Clinically Relevant Pharmacokinetic Drug Interactions

Lack of Drug Interactions with Pravastatin

Safety Considerations Musculoskeletal

Rhabdomyolysis

Rhabdomyolysis Reported During Pravastatin Use

Post-Marketing Cases of Rhabdomyolysis Show No Apparent Relationship to Dose or Country

Rhabdomyolysis Summary

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Pravachol Liver Monitoring Label History: Reduction of Monitoring Requirements Over Time

No Statistically Significant Differences Between Pravastatin and Placebo in Abnormalities of ALT

No Statistically Significant Differences Between Pravastatin and Placebo in Abnormalities of ALT in Subjects with an Elevated Baseline Value

Pravachol Hepatobiliary Safety

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Pravachol Safety Considerations: Pregnancy

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Author: villat