Drug safety and regulation

The Aprotinin Story: Lessons in Drug Regulation and Safety

Issues of drug regulation and safety are a familiar concern within the pharmaceutical industry and often do not emerge until several years after a drug has been on the market. The antifibrinolytic drug aprotinin (Trasylol) was developed by Bayer Pharmaceuticals and approved to prevent excessive bleeding in patients undergoing coronary artery bypass grafting surgery. After several years of wides...

Food and Drug Administration regulation of food safety.

Drug Safety Unscrambling Post - Approval Drug Safety Monitoring

Among the thorny issues confronting newlyconfirmed FDA Commissioner Gottlieb is the unresolved rulemaking proposal to permit generic drug manufacturers to amend safety warnings in their labels without prior FDA approval. At present, only pioneer branded manufacturers holding New Drug Applications may make such amendments to respond to newlydiscovered evidence of a reasonable association between...

Monitoring and antiepileptic drug safety.

Treatment of patients with epilepsy strives for complete seizure control without intolerable drug side effects. Independent of blood drug levels, toxic effects allow titration to efficacy; however, allergic reactions, metabolically or genetically determined drug-induced illnesses, and idiosyncratic effects of drugs, while rare, may be life-threatening.Monitoring is an attempt to detect serious ...

Drug safety proposals and the intrusion of federal regulation into patient freedom and medical practice.

Life-cycle management of drug safety issues requires vigilant postmarket monitoring. Increasingly, however, this concept also includes direct management of how drugs are used, to minimize risks and maximize benefits. Legislative proposals from Senators Kennedy and Enzi, as well as plans offered by the Institute of Medicine, are promoting the more widespread adoption of risk-management plans to ...