Postmarket safety in Canada: are significant therapeutic advances and biologics less safe than other drugs? A cohort study

Objectives: Examine the probability of new active substances (NASs) approved in Canada between 1 January 1997 and 31 March 2012 acquiring a serious postmarket safety warning. Design: Cohort study. Data sources: Annual reports of the Therapeutic Products Directorate and the Biologic and Genetic Therapies Directorate; evaluations of therapeutic innovation from the Patented Medicine Prices Review Board and Prescrire International; MedEffect Canada website. Interventions: Postmarket regulatory safety warning or withdrawal from market due to safety reasons. Primary and secondary outcome measures: Compare the probability of acquiring a postmarket safety warning in Canada in four different groups of drugs: (1) traditional medications versus biologics; (2) medications that offer significant new therapeutic benefits versus those that do not. Determine how well the type of review that an NAS received from Health Canada predicted the product's postmarket therapeutic value. Results: The probability...