E-DRUG: Post-marketing withdrawal of 462 medicinal products due to ADRs
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Post-marketing withdrawal of 462 medicinal products because of adverse drug
reactions: a systematic review of the world literature
- Igho J. Onakpoya
Email author <igho.onakpoya@phc.ox.ac.uk>
- Carl J. Heneghan and
- Jeffrey K. Aronson
BMC Medicine 2016 14:10
Onakpoya et al. 2016
Published: 4 February 2016
http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0553-2
Abstract
Background
There have been no studies of the patterns of post-marketing withdrawals of
medicinal products to which adverse reactions have been attributed. We
identified medicinal products that were withdrawn because of adverse drug
reactions, examined the evidence to support such withdrawals, and explored
the pattern of withdrawals across countries.
Methods
We searched PubMed, Google Scholar, the WHO's database of drugs, the
websites of drug regulatory authorities, and textbooks. We included
medicinal products withdrawn between 1950 and 2014 and assessed the levels
of evidence used in making withdrawal decisions using the criteria of the
Oxford Centre for Evidence Based Medicine.
Results
We identified 462 medicinal products that were withdrawn from the market
between 1953 and 2013, the most common reason being hepatotoxicity. The
supporting evidence in 72 % of cases consisted of anecdotal reports.
Only 43 (9.34 %) drugs were withdrawn worldwide and 179 (39 %) were withdrawn in
one country only. Withdrawal was significantly less likely in Africa than
in other continents (Europe, the Americas, Asia, and Australasia and
Oceania).
The median interval between the first reported adverse reaction
and the year of first withdrawal was 6 years (IQR, 1-15) and the interval
did not consistently shorten over time.
Conclusion
There are discrepancies in the patterns of withdrawal of medicinal products
from the market when adverse reactions are suspected, and withdrawals are
inconsistent across countries. Greater co-ordination among drug regulatory
authorities and increased transparency in reporting suspected adverse drug
reactions would help improve current decision-making processes.
Keywords
Adverse drug reaction, Drug withdrawal, Systematic review, Voluntary recall
Bruneton Carinne
E-DRUG team
<carinne.bruneton@gmail.com>