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Unnecessary deaths linked to drug withdrawal process

A more efficient and effective drug withdrawal process could lead to avoidance of unnecessary deaths, according to a recently published study in BMC Medicine.

“These results suggest that some deaths associated with these products could have been avoided. These data suggest that better methods are needed to detect, document and report deaths in patients taking medications in order to reduce delays further,” Igho J. Onakpoya, MD, MSc, of the Nuffield Department of Primary Care Heath Science, Centre for Evidence-based Medicine at the University of Oxford, and colleagues wrote.

Researchers used data on adverse drug reactions gathered from the World Health Organization’s Consolidated List of [Medicinal] Products, drug regulatory authorities’ websites, PubMed, Google Scholar and textbooks, to assess which products documented death as a reason for market withdrawal. Products were included regardless of whether the deaths had occurred at therapeutic or toxic doses.  

Results demonstrated that between 1950 and 2013, 95 drugs had death documented as a reason for withdrawal. Of the withdrawn drugs, 28 were used to treat psychiatric or neurological disorders, 21 were analgesics or anti-inflammatory drugs, 14 were used for cardiorespiratory disorders and 9 were anti-microbial drugs.

Researchers found that while at least 40% of drugs were withdrawn in more than one country, only 27% were withdrawn worldwide. Withdrawals were most common in European countries, with significantly fewer withdrawals in African and Asian countries.

Researchers noted that while the time between launch date and reports of death has shortened in recent decades, many withdrawals still took place more than 1 or 2 years after reports of death began to occur. Over the last 60 years, there has been no improvement in the time between the first report of death attributed to a medicinal product and the eventual withdrawal, with the average time being 4 years.

Expediting investigations into drugs that have death reported as an adverse effect and early suspension consideration should be contemplated by manufacturers and regulatory authorities, according to researchers.

“Increased transparency in the publication of clinical trials data and improved international co-ordinations could shorten the delays in withdrawing dangerous medicinal products after reports of death and obviate discrepancies in drug withdrawals in different countries,” Onakpoya and colleagues wrote. – by Casey Hower

Disclosure: Onakpoya reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.