If a drug caused harmful effects after approval and had been withdrawn in some countries, where would you think that drug would be most likely to be still available? The answer is: AFRICA
How do we know this?
In a systematic review of the world literature, published in BMC Medicine, we analysed the post-marketing withdrawal of 462 medicinal products because of adverse drug reactions.
We searched for information from scientific databases and textbooks about medicines that have been withdrawn by regulators from the market because of harmful effects over the last 60 years. After identifying each product, we documented the year in which the product was first approved for use, the year in which an adverse reaction was first reported, the year in which it was first withdrawn, and all the countries in which the medicine was withdrawn.
What did we find?
We found 462 medicines that were withdrawn between 1953 and 2013. The most common reason for withdrawals was liver damage. Less than 10% of the medicines were withdrawn worldwide, and almost 40% were withdrawn in only one country. Withdrawals were significantly less likely in Africa than in Asia, Europe, Australasia and Oceania, and South and North America. Anecdotal reports were cited as evidence for withdrawal in 71% of cases, and deaths were reported as reasons for withdrawal in 25%. The interval between reports of adverse reactions and subsequent withdrawal from the market did not consistently shorten with time.
What does this mean?
Medicines that cause harmful effects are more likely to be available in countries with lower GDP. Therefore, there should be greater efforts to improve drug monitoring systems in such countries. Improved coordination amongst drug regulatory authorities would improve discrepancies in drug withdrawal patterns across countries and across continents.
So where do you think you are most likely to find harmful medicines?
You can access the full report of this work at:
Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature, is published in BMC Medicine (http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0553-2).
Related News article:
Medicine safety ‘needs international coordination University of Oxford News & Events