The occurrence of severe adverse events led to the withdrawal of 19 medicinal products from the European market between 2002 and 2011. Cardiovascular events were responsible for 9 of the 19 withdrawals, while hepatic and psychiatric adverse events each accounted for 4 of the 19 cases.
Although spontaneous reporting of adverse drug reactions played a key role in withdrawal decisions, clinical studies published in the scientific literature contributed to approximately two-thirds of these regulatory actions.
A study on case reports highlights the importance of scientific literature
In particular, case reports were cited in 95% of drug withdrawals (18 out of 19 cases), while randomized clinical trials (RCTs) were cited in 63% (12 of 19 cases). Meta-analyses contributed to 26% (5 of 19 cases), whereas case-control studies and cohort studies were each cited in 21% (4 of 19 cases).
These findings were published by Rhian McNaughton and colleagues in the British Medical Journal.
The researchers analyzed the scientific evidence supporting drug withdrawal decisions through searches conducted in PubMed, the websites of the European Medicines Agency (EMA), and other European regulatory authorities.
“Spontaneous reports should be used alongside other pharmacovigilance tools, such as observational studies and clinical trials, to more thoroughly evaluate each safety signal, due to the risk of over-reporting, under-reporting, confounding factors, bias, and misclassification.”
Rhian McNaughton