Contraception Methods in Drug Labeling
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Contraception Methods in Drug Labeling
Drug Information Journal 46(3) 320-328 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512441099 http://dij.sagepub.com
Christianne O. Parotti, BPharm1, Eric W. Ng, MD1, and Diego F. Wyszynski, MD, MHS, PhD1
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. Keywords reproductive toxicity, birth control, guidance, label, prescribing information
Introduction Worldwide, women have been using more prescription medications over the past decades.1-3 Mitchell et al found that between 1976 and 2008, first-trimester use of prescription medications increased by more than 60% and that the use of 4 or more medications more than tripled in the first trimester of pregnancy.4 Schwarz et al reported that 1 in 6 women of reproductive age use potentially teratogenic medications.5 With estimates that about half of the pregnancies in the United States are unintended,6 many women may inadvertently expose their fetus to potentially teratogenic drugs.7 As a result, patients need reliable guidance on proper contraceptive use when taking medications that may adversely affect a fetus. Most drugs in the United States must contain information in their labeling regarding use during pregnancy to be approved for marketing.8 All drugs labeled as pregnancy category ‘‘D’’ or ‘‘X’’ by the US FDA have the potential to cause harm to a developing fetus.8 Between 1998 and 2001, there were approximately 147 million annual office visits made by women of childbearing age.9 Of these, an estimated 11 million visits made by women of childbearing age documented use of 11.7 million class ‘‘D’’ or ‘‘X’’ medications.9 However, contraceptive counseling was provided in only about 20.9% of the visits at which such medication was prescribed.9
Drug labeling is an important source of information that patients use in an effort to understand the risks and benefits of a particular medication.10 Unfortunately, the contents of the labeling are o
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