Contraception Methods in Drug Labeling

Abstract

Background Recent studies have shown that approximately 1 in 6 women of reproductive age use potentially teratogenic medications. Since the pregnancy section in drug labeling is often inconsistent or incomplete, many pregnant women may inadvertently expose their fetus to potentially teratogenic drugs. Method We examined the pregnancy section in the labeling of 6 potentially teratogenic drugs: thalidomide, isotretinoin, leflunomide, warfarin sodium, alprazolam, and lisinopril. We also reviewed regulatory guidelines that address issues regarding contraception method use. Results The amount of information regarding contraception use in drug labeling varied. Occasionally, this information was not found altogether. Regulatory guidelines regarding contraception use, albeit useful, do not comprehensively cover all relevant areas. Conclusion There is a need for an internationally harmonized regulatory guideline that clearly defines when, how, and what type of contraception methods should be used, as well as what type of contraception information should be included in the labeling.