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#Grand Rounds

Are Women at Higher Risk for Adverse Drug Reactions?

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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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Related ObG Topics:

The VIRGO Study Results: In Younger Individuals, Does Heart Attack Presentation Differ Between Women and Men?
Herb-drug Interactions – How Severe are Potential Adverse Drug Reactions?
Is the Prognosis for Aortic Aneurysm Worse for Women than for Men?

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