Dataset Information

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) 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The probability of a traditional NAS acquiring a serious safety warning and/or being withdrawn was 29.9% (95% CI 21.8% to 40.2%) vs 27.3% (95% CI 18.2% to 39.7%) for an NAS of biological origin (p=0.47, log-rank test). For medications that were significant therapeutic advances the probability was 40.2% (95% CI 24.5% to 60.9%) vs 33.9% (95% CI 26.4% to 42.7%) for those that were not (p=0.18, log-rank test). Health Canada was 77.4% accurate in predicting the therapeutic importance of an NAS.

Conclusions

There was no difference in postmarket regulatory safety action between traditional medications and biologics and no difference between drugs with significant therapeutic benefits and those without. Although these results draw on Canadian data, they are likely to be relevant internationally. Further research should assess whether the current level of premarket safety evaluation is acceptable.

SUBMITTER: Lexchin J

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

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Lexchin Joel J

BMJ open 20140218 2

<h4>Objectives</h4>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.<h4>Design</h4>Cohort study.<h4>Data sources</h4>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.<h4>Interventions</h4>Po ...[more]

PMID: 24549164

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Project description:BackgroundWe examined how often new serious safety signals were identified by the U.S. Food and Drug Administration within the first 2 years after approval for new molecular entities (NMEs) for treatment of cancer that required specific regulatory actions described here.MethodsWe identified, for all NMEs approved for treatment of cancer or malignant hematology indications between 2010 and 2016, substantial safety-related changes within the first 2 years after approval, which included a new Boxed Warning or Warning and Precaution; requirement for (or modification of existing) Risk Evaluation and Mitigation Strategies (REMS); and withdrawal from the market because of safety concerns.ResultsFifty-five NMEs were approved between 2010 and 2016: 32 (58%) under regular approval (RA) and 23 (42%) under accelerated approval (AA). Of these 55 NMEs, 9 (16%) had substantial safety-related changes after approval. Across all 55 NMEs, one was temporarily withdrawn from the market for safety reasons (1.8%); one (1.8%) required a new REMS; nine required labeling revisions-new Boxed Warnings were required for two NMEs (3.6%), and new Warnings and Precautions subsections were required for eight (14.6%). One drug (ponatinib) was responsible for several of the substantial safety-related changes (withdrawal, REMS, Boxed Warnings). One of 32 NMEs approved under RA required a new Warning and Precaution, whereas 7 of 23 NMEs approved under AA had substantial safety-related changes in the first 2 years after approval.ConclusionBased on our analysis we conclude that although there was a greater incidence of substantial safety-related changes to AA drugs versus RA drugs, the majority of these were changes to the Warnings and Precautions and did not substantially alter the benefit-risk profile of the drug.Implications for practiceThe majority of new cancer drugs (84%) approved in the U.S. do not have new substantial safety information being added to the label within the first 2 years of approval. Unprecedented efficacy seen in contemporary cancer drug development has led to early availability of effective cancer therapies based on large effects in smaller populations. More limited premarket safety data require diligent postmarketing safety surveillance as we continue to learn and update drug labeling throughout the product lifecycle.

Dataset Information

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

Objectives

Design

Data sources

Interventions

Primary and secondary outcome measures

Results

Conclusions

Publications

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

Similar Datasets

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