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

METHODS:

• 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

RESULTS:

• 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

CONCLUSION:

• 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

Learn More – Primary Sources:

Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study

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