title: FDA drug labeling for pregnancy and lactation drug safety monitoring systems.
abstract: The product label required by the FDA for every drug approved for marketing in the US is a legal document that originates with the company that wants to market the drug, but it must be approved by the FDA. Despite the recognized limitations of registries, the FDA's new labeling rule, effective from July 1, 2015, has given the data available from post-marketing surveillance priority in the new label. For this information to be maximally useful to both providers and consumers, providers must refer as many exposed consumers as possible to the registries, preferably prior to knowledge of the outcomes of the pregnancies. Consumers need to cooperate with the registries to share their health information with as much detail as possible with the registries. It will take years to accumulate a meaningful quantity of information in many of the registries, but they promise to be our best hope for useful counseling information in the future.
authors.affiliation: Vincent Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114. Electronic address: Greene.Michael@mgh.harvard.edu.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Greene
mesh_terms: D000328:Adult; D001942:Breast Feeding; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000458:organization & administration; D004346:Drug Information Services; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007774:Lactation / Q000187:drug effects*; D018579:Patient Selection; D011247:Pregnancy; D037841:Pregnant People; D055553:Prescription Drugs / Q000493:pharmacokinetics; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D055553:Prescription Drugs