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Making Sense of Medications in Pregnancy

Sarah Shaffer DO, FACOG, NCMP2019 Iowa Physician Assistant Society Fall CME Conference

No Disclosures

Learning Objectives

• Review FDA guidance for medications in pregnancy – past & present

• Examine various resources for providers & patients to obtain information about specific medications and other exposures in pregnancy

• Consider what information should be routinely shared with pregnant patients regarding medication use in pregnancy – OTC & prescription

How long ago did the FDA release the original medication in pregnancy risk categories?

• Pregnancy medication categories

• Category A: Controlled studies show no risk or find no evidence of harm.

• Category B: Animal studies show no risks, but there are no controlled studies in pregnant women.

• Category C: Animal studies have shown risk to the fetus, there are no controlled studies in women, or studies in women and animals are not available.

• Category D: There is positive evidence of potential fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (i.e. life-threatening condition to mother).

• Category X: Studies in animals or human beings have demonstrated fetal abnormalities, or there is evidence of fetal risk. The drug is contraindicated in women who are or may become pregnant.

• 1959

• 1979

• 1999

These categories have been replaced!!!

How long ago did the FDA release the updatedmedication in pregnancy labeling guidance?

• Pregnancy and Lactation Labeling Final Rule (PLLR)

• Pregnancy (includes Labor and Delivery)• Pregnancy Exposure Registry• Risk Summary• Clinical Considerations• Data

• Lactation (includes Nursing Mothers)• Risk Summary• Clinical Considerations• Data

• Females and Males of Reproductive Potential• Pregnancy Testing• Contraception• Infertility

• 2005

• 2010

• 2015

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Image from: https://www.fda.gov/drugs/labeling/pregnancy-and-lactation-labeling-drugs-final-rule

Where do I go to find information for my patients?

• 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.• Pillbox - website was developed to help quickly identify medications by their

appearance and ingredients as well as exploring current and past marketed products

When was the last time a patient asked you about the effects of Ecstasy use on pregnancy and breast feeding?

• Last week-ish

• Last year-ish

• Never!!

• MotherToBaby - a service of the Organization of Teratology

Information Specialists (OTIS)

• Refer Your Patient - a service offering exposure counseling & information

and/or study participation

• For patients who are planning pregnancy, pregnant, or lactating

• Fact Sheets – printable information that answer frequently asked questions

about exposures during pregnancy and breastfeeding

• Includes: Medications, Herbal Products, Infections and Vaccines, Maternal Medical

Conditions, Substances of Abuse, Other Common Exposures, Occupational Exposures

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“I don’t like to take medicine…”

• Provide general recommendations for medications use

• Utility if having a list of “safe” or “approved” medications, especially over-the-counter (OTC) options

• ALSO: provide a brief list of the most common, OTC options that should be avoided in pregnancy with an explanation as to why they might be detrimental

General Recommendations for Patients• Always consult your doctor: You should never start or stop taking medication while pregnant without first consulting

your health care provider.

• Read the Label: Look for warnings or pregnancy indications. You should also consideration expiration dates. Finally, always watch for potential allergic reactions.

• Be aware of side effects: Consult your health care provider or the pharmacist about potential side effects. Some medications cause side effects like sleepiness, headaches, or vomiting which may be enhanced because of pregnancy hormones.

• Organize your medications: Be careful to not mix up your medications to avoid overdosing.

• Do not skip medications: Take as prescribed by your health care provider

• Do not share medications!

• Ask Questions: It is appropriate to ask questions about medication safety for you and your developing baby. Ask about the medication name, generic alternatives, benefits and risks, and problems to watch for.

• Keep Records: It is always beneficial to keep a record of medications taken whether pregnant or not. This becomes even more important if you are expecting.

• Check Pregnancy Medication Registries: The FDA has a new pregnancy and medication registry that may be helpful.

“I don’t like to take medicine…” (continued)

• ALSO: provide a brief list of the most common, OTC options that should be avoided in pregnancy with an explanation as to why they might be detrimental

• E.g. ”You may use stool softeners, but avoid laxatives as they cause cramping of the bowels, which may cause cramping of the uterus and/or bleeding from the uterus. There are also rare reports of negative effects on maternal nutritional levels, maternal & fetal electrolyte balance, and preterm labor.”

• Establish a schedule & responsible party to review all patient information regularly (suggestion: every two years)

When was the last time a patient asked you about the effects of sumatriptan use during pregnancy or while breast feeding?

• Last week-ish

• Last month-ish

• Last year-ish

Prescription Medications

• Example = sumatriptan• 25% of women migraine headache symptoms remain the same or get worse• Some studies have shown that women with a history of migraine headaches

have a slightly higher chance for high blood pressure, preeclampsia, and pregnancy-related stroke.• Several studies have noticed a small increased chance for preeclampsia,

preterm birth, low birth weight, and heavy bleeding following delivery with use late in pregnancy. • However, it is not yet clear if these outcomes were due to the migraines only, or the

medications only, or a combination of both the condition & the treatment.

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Teratogenic Medications• Most female patients and/or

their providers are aware of teratogenic medications• Types of teratogens• Physical agents• Metabolic conditions• Infections• Drugs & chemicals

• When it matters most…• 1st trimester = prior to 12+0 weeks

of gestation

• Barriers to Provision of Teratogenic Risk Counseling in Primary Care Settings• Time• Lack of reimbursement• Finding clinically relevant information is difficult &

time consuming• Non-use of needed medications due to patient

anxiety about teratogenic risks• Difficulty identifying patients’ pregnancy plans

• Potential Facilitators of Teratogenic Risk Counseling in Primary Care Settings• On-line references & information• Computerized decision support• Assistance in identifying patients’ pregnancy plans• Patient education materials

References• https://www.fda.gov/drugs/labeling/pregnancy-and-

lactation-labeling-drugs-final-rule

• https://www.drugs.com/pregnancy-categories.html

• https://americanpregnancy.org/medication/medication-

and-pregnancy/

• https://www.accessdata.fda.gov/scripts/cder/daf/index.cf

m

• https://www.fda.gov/drugs/postmarket-drug-safety-

information-patients-and-providers/index-drug-specific-

information

• https://dailymed.nlm.nih.gov/dailymed/index.cfm

• https://pillbox.nlm.nih.gov

• https://mothertobaby.org

• https://www.aafp.org/afp/2014/1015/p548.html#afp201

41015p548-b59

• PMID: 16831610 & 19591115Image from: https://americanpregnancy.org/medication/medication-and-pregnancy/