Pregnancy Registry Information for Health Professionals
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Sign Up Your Patients
Enrolling your patients in a pregnancy exposure registry can help improve safety information for medicines used during pregnancy and can be used to update drug labeling.
- Check the list of registries. The list includes the website and phone number for you to contact each registry.
- Encourage your patients to enroll.
Remind your patients that they will not be given an experimental drug. Pregnancy registries collect information on pregnancy outcomes in women who are already taking medication.
- Get free medicine and pregnancy resources to share with your patients.
FDA offers free tear pads, fact sheets and website cards.
Pregnancy and Lactation Labeling
The format and content of prescription drug labeling is changing for information about medication use during pregnancy and lactation. In the Pregnancy subsection, the pregnancy letter category will be removed. For drugs approved on or after June 30 2001, the pregnancy letter categories will be replaced with a Risk Summary that provides a detailed summary of the risks and benefits of using a drug during pregnancy. The “Nursing Mothers” subsection will be renamed “Lactation”.
There is a new subsection called “Females and Males of Reproductive Potential” that provides information on pregnancy testing and contraception recommendations and information about a drug’s effects on fertility when this information is needed.
Newly approved drugs will be required to use the new format beginning on June 30, 2015, while revised labeling t for previously approved products will be phased in over the next 3-5 years.
- Learn more about the Pregnancy and Lactation Labeling Rule
Other Drug Information
- Drugs@FDA – Product labels and other information on FDA-approved drugs.
- Drug Specific Information - Index of information on some FDA-approved drugs.
- Daily Med - National Library of Medicine website where you can find information from the drug labels for over 20,000 drugs.
- MotherToBaby, a service of the Organization of Teratology Information Specialists (OTIS) - Speak with a counselor about exposures during pregnant or breastfeeding. 1-866-626-6847