UBC Faculty Research and Publications

Drug Safety Advisories : A need for international coordination University of British Columbia. Therapeutics Initiative


Therapeutics Letter 128 highlights the need for international coordination on drug safety advisories. Conclusions: Observational studies have identified signals of serious harms from long-term PPI exposure, including an increased risk of death. Even large RCTs may not detect these, if exposure or follow-up are insufficiently long. The COMPASS trial findings are not inconsistent with contemporaneous findings from observational studies. Clinicians and patienConclusions Better awareness of drug safety advisories from their own and other countries could help prescribers and patients seek the safest available drugs. When drug safety warnings differ, clinicians and the public need to know why. Regulators should provide the underlying rationale and an international context when issuing new drug safety warnings.ts can reverse the relentless expansion of long-term PPI exposure by reviewing indications and considering potential harms as well as benefits.

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