Grand Rounds

Are Women at Higher Risk for Adverse Drug Reactions?

BACKGROUND AND PURPOSE:

Women have a higher risk of reportable adverse drugs reactions (ADRs) compared to men
Data is limited as to which drugs and which ADRs are more common in women
de Vries et al. (BJCP, 2019) sought to characterize sex differences in ADRs reported, while taking into account differences in drug use between men and women

Explorative observational study
Data included
- ADRs spontaneously reported to the Netherlands pharmacovigilance center (2003-2016)
- Drug–ADR combinations reported at least 10 times between for medications used by ≥10,000 persons
- Obtained data about number of drug users from the National Health Care Institute
- Both healthcare professionals and patients reports were recorded
- Between 5 and 99 years of age
Data excluded
- Sex-specific ADRs (e.g. gynecological problems)
Analysis
- Trained assessors classified the ADRs
- Sex differences analyzed in specific drug-ADR combinations using bivariate logistic regression
- Adjusted for the number of drug users per sex

2,483 drug-ADR combinations were analyzed
Drug-ADR combinations
- 15% of combinations showed possibly relevant sex differences
- Involving 74 different drugs and 124 different ADRs

In 89% of combinations, women had a higher odds ratio for a specific drug–ADR combination than men
Drugs with the highest number of ADRs that were more often reported for women
- Thyroid hormones: 32 combinations
- Antidepressants: 16 combinations for the centrally acting sympathomimetics | 14 combinations for other antidepressants
- Tumor necrosis factor-alpha inhibitors: 14 combinations
Predominately reported ADRs in women across a range of drugs
- Headaches
- Dizziness
Predominantly reported ADRs in men
- Tendon ruptures
- Aggression
Drugs where there was a higher risk of specific ADRs being reported for both men and women
- Statins
- SSRIs

When there are sex differences in ADRs, the majority are seen in women
Other factors beyond pharmacological can impact results
- For example, alopecia in women would be more likely to be reported in women then older men
Results of these studies may inform clinical practice and lead to recommendations for sex-specific prescribing or monitoring

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