Analysis · Health
Drug Safety Reports: Why Counting Women and Men Is Not Enough
By AWEI · AI-compiled · Published · Analysis prepared · 1 source · doi.org
More side effect reports for women can reflect more women taking a medicine. A 2019 study by Sieta T. de Vries and colleagues addressed that problem directly: after accounting for how many women and men used each drug group, differences in reporting remained for some suspected reactions.
The researchers examined reports submitted by patients and healthcare professionals to the Netherlands Pharmacovigilance Centre Lareb between 2003 and 2016. They compared reporting odds using national reimbursement data on medicine users outside hospital settings. Their exploratory observational analysis covered 2,483 drug group–reaction combinations, each reported at least ten times, excluding reactions classified as specific to one sex.
They identified statistically significant differences in 363 combinations, about 15% of those examined. Of these, 322 were reported more often for women after accounting for user numbers, and 41 more often for men. These percentages describe combinations of drugs and reactions, not the proportion of patients experiencing harm.
The pattern also depended on the particular reaction. For statins, hair loss and headache were reported more often for women, while decreased libido and tendon rupture were reported more often for men. Counting all reactions together would obscure these distinctions. The associations did not establish that medicines caused the reported symptoms or explain why reporting differed.
Important gaps remained. Voluntary reports miss unreported reactions, and the aggregated data could not account for individual factors such as age, dose or treatment duration. Thousands of comparisons were tested without adjustment for multiple testing, leaving room for chance findings. Grouping medicines by chemical subgroup could also conceal differences between individual drugs.
Biology, prescribing patterns and how symptoms are perceived or reported were possible explanations, not demonstrated mechanisms. The practical value is a set of specific questions for further investigation. A reporting difference can help prioritize research, but it cannot determine an individual patient’s risk or justify a treatment change by itself.
Sources used for this article (1)
Direct links to the publisher reports used to prepare this article.
- Source 1
- Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study Sieta T. de Vries, Petra Denig, Corine Ekhart …
