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A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
Risk minimization practices for pregnancy prevention: understanding risk, selecting tools.
Kathleen Uhl1, Anne Trontell, Dianne Kennedy
1US Food and Drug Administration, Office of Women's Health, Rockville, MD 20857, USA. kathleen.uhl@fda.hhs.gov
Pharmacoepidemiology and Drug Safety
|September 6, 2006
Summary
Preventing birth defects from medications is crucial. This paper discusses strategies for drug risk management to minimize fetal exposure while ensuring patient access to beneficial treatments.
Area of Science:
- Pharmacology
- Teratology
- Public Health
Background:
- Approximately 4% of US births have birth defects, with unknown causes for most.
- Drug-induced birth defects are rare (<1%) but preventable through risk management.
- Identifying teratogenicity early in drug development is vital.
Purpose of the Study:
- To outline considerations for developing risk minimization programs for drugs.
- To prevent fetal drug exposure during pregnancy.
- To optimize the benefit-risk balance for medications.
Main Methods:
- Review of general considerations for risk minimization programs.
- Analysis of strategies to prevent fetal drug exposure.
- Evaluation of advantages and disadvantages of different approaches.
Main Results:
- Risk assessment and minimization are key components of drug risk management.
- Tailored and consistent approaches are necessary for effective risk minimization.
- Strategies aim to balance drug benefits with fetal safety.
Conclusions:
- Effective risk management programs are essential for preventing drug-induced birth defects.
- Product-specific concerns should guide the development of risk minimization strategies.
- Optimizing benefit-risk balance ensures safe and effective medication use during pregnancy.
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