ArticleOpen medicine : a peer-reviewed, independent, open-access journal2014
How safe are new drugs? Market withdrawal of drugs approved in Canada between 1990 and 2009.
Article in Open medicine : a peer-reviewed, independent, open-access journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Pooled it
- Article
- Early Identification of Cardiovascular Adverse Events Associated With Rofecoxib Using Real-World Data From the UK: A Nested Case-Control and Case-Crossover Study.Pharmacoepidemiology and drug safety · 2026Article
- Drugs Withdrawn from the Canadian Market for Safety and Effectiveness Reasons, 1990-2024: A Cross-Sectional Study.Drug safety · 2026Article
- Acute cardiovascular effects associated with the use of prescription medications: A Danish nationwide screening study.British journal of clinical pharmacology · 2025Article
- Equine Pergolide Toxicity: A Case Series.Cureus · 2024Article
- Pharmacovigilance and Appropriate Drug Use.Healthcare (Basel, Switzerland) · 2024Article
- Drug approval status and recommendations for listing on public formularies: a Canadian cohort analysis.BMJ open · 2017Article
- Medicines Save, Medicines Kill.Drug safety · 2017Article
- How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study.Healthcare policy = Politiques de sante · 2016Article
- Understanding Users in the 'Field' of Medications.Pharmacy (Basel, Switzerland) · 2016Article
- A web resource for mining HLA associations with adverse drug reactions: HLA-ADR.Database : the journal of biological databases and curation · 2016Article
- Illicit Internet availability of drugs subject to recall and patient safety consequences.International journal of clinical pharmacy · 2015Article
- On the predictive utility of animal models of osteoarthritis.Arthritis research & therapy · 2015Review
- Regulating prescription drugs for patient safety: does Bill C-17 go far enough?CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2014Review
- Quality and quantity of information in summary basis of decision documents issued by health Canada.PloS one · 2014Article
- Characterization of Serious Adverse Drug Reactions in Hospital to Determine Potential Implications of Mandatory Reporting.The Canadian journal of hospital pharmacyArticle
- Pharmacy Student Facilitation of Reporting of Adverse Drug Reactions in a Hospital.The Canadian journal of hospital pharmacyArticle
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundStudying drugs withdrawn from the market for safety reasons can help in evaluating the strengths and weaknesses of the pre- and post-market safety evaluation systems. This study considered 2 questions: Has there been a change over time in the percentage of new drugs that are eventually withdrawn because of safety reasons? How long are new drugs on the market before their serious safety problems are recognized?
methodsAll drugs approved between 1 January 1990 and 31 December 2009 and subsequently withdrawn for safety reasons (until 1 October 2013) were identified, and the generic name, date of approval, and date of withdrawal were recorded. The total number of drugs approved over the same period was obtained from annual Health Canada reports. The percentages of new active substances approved in the 5-year periods 1990-1994, 1995-1999, 2000-2004, and 2005-2009 and eventually withdrawn were compared using the χ(2) test. The time between approval and withdrawal was calculated in days.
resultsOf the 528 new drugs approved over the period of interest, a total of 22 (4.2%) were eventually withdrawn. Between 3.9% and 4.4% of the drugs approved in each 5-year period were eventually withdrawn (χ(2) = 0.04, p = 0.99 for difference among 5-year periods). The median time between approval and withdrawal was 1271 days (interquartile range 706-2876).
interpretationOne explanation for the finding of no difference in the percentage of drugs approved in the four 5-year periods that were eventually withdrawn is the lack of any change in the rigour of the premarket evaluation system and the postmarket surveillance systems. The 1271-day median time between Notice of Compliance and withdrawal emphasizes the need to be particularly cautious in prescribing new drugs early in their life cycle.
Indexed as
Identifiers
25009681PMC4085091W1584507582What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.