Preventing postmarketing changes in recommended doses and marketing withdrawals.
Recent market withdrawals of prescription drug products have brought attention to premarketing safety research. Less known but related to some drug withdrawals are postmarketing dosage changes of newly marketed drugs, including both dosage reductions and increases. These events have serious effects on patients, manufacturers, and regulatory authorities. Most of these harmful events could be avoided by intensive employment of targeted clinical pharmacology investigations to optimize dosage prior to phase III testing and regulatory approval. In this paper, the frequency and implications of postmarketing dosing changes and market withdrawals are considered in light of approaches to preventing them.
Peck
C
C
UCSF Center for Drug Development Science, Washington, DC 20036, USA. carl_peck@compuserve.com
D016907:Adverse Drug Reaction Reporting Systems; D017277:Drug Approval / Q000379:methods*; D004348:Drug Labeling; D011307:Drug Prescriptions; D006801:Humans; D007880:Legislation, Drug; D008389:Marketing of Health Services; D004364:Pharmaceutical Preparations; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations