Identifying Sex Differences in Adverse Events Reported on Opioid Drugs in the FDA's Adverse Event Reporting System...

Area of Science:

• Pharmacology
• Clinical Pharmacy
• Drug Safety

Background:

• Opioid analgesics are common for pain but carry risks.
• Adverse event profiles may differ between sexes.
• Post-marketing surveillance rarely analyzes individual-level sex differences in opioid safety.

Purpose of the Study:

• To identify sex disparities in opioid-associated adverse events.
• To analyze data from the FDA Adverse Event Reporting System (FAERS).
• To inform safer opioid selection and monitoring for women.

Main Methods:

• Opioids identified from FDA's REMS list and labeling.
• FAERS reports extracted and adverse events classified by System Organ Classes (SOCs) using MedDRA.
• Sex-specific reporting disproportionality assessed using PRR and ROR.

Main Results:

• Adverse events were reported more frequently in women across most opioids and SOCs.
• Significant sex disparities favoring higher reporting in women observed for codeine, fentanyl, tapentadol, hydrocodone, and sufentanil.
• Pronounced sex-specific differences in post-marketing safety profiles of common opioids identified.

Conclusions:

• Women exhibit higher disproportionate reporting of adverse events for specific opioids like codeine and fentanyl.
• Increased awareness of sex-specific safety differences is crucial for opioid use.
• Sex-informed prescribing and monitoring strategies can enhance opioid safety in women, with pharmacists playing a key role.