On average, four years elapse between the first observations of deaths attributed to drugs and their withdrawal from the market. A duration that has not changed in 50 years, deplore researchers.
Medicines heal. But some can do more harm than good, and even lead to death. How long does it take between the first observations of serious side effects, especially death, and market withdrawals? English researchers have looked into the question and deliver their results in the journal BMC Medicine.
Igho Onakpoya, and his colleagues at the University of Oxford, screened several databases, including those of the American and European drug agencies (FDA and EMA) and the World Health Organization (WHO) . They identified 407 drugs withdrawn from the market worldwide between 1950 and 2013.
95 drugs
Among these, they were more particularly interested in 95 drugs whose marketing was stopped in at least one country following deaths. In more than half of the cases, these drugs had toxicity to the heart, liver or lungs.
Withdrawn from the market between 1957 and 2011, most of these drugs were administered to treat neurological or psychiatric pathologies. They were also analgesics or anti-inflammatory drugs. Finally, there were drugs used for cardiorespiratory pathologies and antimicrobials.
4 years on average
In more than 50 years, the time between the first notifications of deaths attributed to the drug and their withdrawal from the market has not changed. She is still an average of four years old. Or more than two years in 47% of cases. Finally, 16 drugs were still marketed in some countries.
Researchers recognize, however, that notifications of the first deaths attributed to drugs are increasingly occurring soon after these products are marketed. But scientists are asking that regulatory actions be faster after the notification of suspected serious adverse reactions and that there be more international coordination in pharmacovigilance.
.