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

ABSTRACT:

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) medication

SUBMITTER: Lexchin J 

PROVIDER: S-EPMC3931983 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature