Meanwhile, some suspended drugs were returned to the market. In the case of the anxiety medicine meprobamate, we know this was gradually withdrawn over the duration of our study period. This could have been because other strengths and formulations that remained on the market were misclassified. Most notably, we found that usage of the withdrawn drugs did not always drop to zero within 12 months of regulatory action.

There were, of course, limitations to the study. The total was an estimated 3,020 per year. This risk, expressed as a percentage of people using the drug, was based on the estimated annual number of people exposed and the number of adverse reactions.Īn estimate of the number of adverse reactions prevented as a result of each product withdrawal, revocation or suspension was also calculated based on the exposure and absolute risk figures. The types of adverse drug reactions examined included low blood pressure, diabetes, cancer, bleeding, involuntary movements and weight loss.Īn absolute risk for each withdrawn drug was calculated using published literature. Then European Medicines Agency (EMA) records were used to identify adverse drug reactions, and a systematic review was carried out to quantify the risk of adverse drug reactions in patients exposed to each withdrawn drug. An estimate of how many people were exposed to the drug each year prior to withdrawal or suspension was calculated. Real-world data was gathered from IQVIA Medical Research Data (IMRD) electronic health records (eHR) databases for France, Germany and the UK to find out how many patients were using each drug during the 12 months before and after regulatory action. cyproterone acetate/ethinylestradiol (Diane-35 and generics) – birth control.some formulations of domperidone – used to prevent sickness and nausea.some formulations of metoclopramide – an anti-sickness medication.calcitonin – able to controls calcium levels, it was used for conditions such as osteoporosis.nicotinic acid/laropiprant – used to lower cholesterol.meprobamate – a sedative used to treat anxiety.Six products were withdrawn or revoked for safety reasons during the study period. It focused on data from France, Germany and the UK. Our research looked at products that were voluntarily withdrawn, or had their licence revoked or suspended within the EU for a safety reason between 20. To aid decisions about potential product withdrawals, we set out to develop a new EBM methodology to show the positive impact this could have with quantifiable modelling of the estimated number of adverse reactions that would be prevented if a specific drug was withdrawn from use. The most severe measures are temporary or permanent product withdrawals. National regulators use pharmacovigilance research when deciding whether risk minimisation measures should be imposed.

One key iqvia