Assessment of the Risk Evaluation and Mitigation Strategy (REMS) for Phentermine–Topiramate to Prevent Exposure During Pregnancy
Authors' conclusion
Prenatal exposure seemed to be significantly lower among phentermine-topiramate users under the REMS. Pregnancy testing and contraceptive use appeared to be inadequate for all groups, which deserves attention to prevent the remaining potential exposures.
Study context
- Population
- Females aged 12 to 55 years with no infertility diagnosis or sterilization procedure; patients with other indications for topiramate excluded
- Participants
- 156,280 treatment episodes
- Exposure
- Phentermine-topiramate vs topiramate or other antiobesity medications
- Outcome
- Prenatal exposure: pregnancy at treatment initiation and conception during treatment
Methodological detailsnationwide health insurance claims database, Measurable confounders adjusted for; extensive sensitivity analyses
- Nationwide health insurance claims database
- Measurable confounders adjusted for; extensive sensitivity analyses
Main finding
As reported in the abstract
Prenatal exposure
Phentermine-topiramate vs TopiramateEstimate (95% CI)
Adjusted
prevalence ratio (pregnancy at treatment initiation; 0.9 vs 1.6 per 1000 episodes) 0.54(0.31–0.95)
Prenatal exposure
rate ratio (conception during treatment; 9.1 vs 15.0 per 1000 person-years) 0.61(0.40–0.91)
Observational data: associations, not effects.
Further findings
≥50% of treatment days covered by contraceptives
- ≈20% of patients in all cohorts
Pregnancy tests before treatment
- Few patients had pregnancy tests before treatment; more common among phentermine-topiramate users
- ≤5%
Original publication
Assessment of the Risk Evaluation and Mitigation Strategy (REMS) for Phentermine–Topiramate to Prevent Exposure During Pregnancy. Ann Intern Med. Published 21 March 2023. doi:10.
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