Pregnancy Section on the Drug Charts
Caution must always be taken with drug use in pregnancy. The recommendation in this section is that a woman and her doctor decide together about the benefits and risks of any drugs used during pregnancy. This recommendation can help remind and encourage a woman to seek medical advice.
The pregnancy risk category (see below) assigned to the drug is listed in this section.
Space limitations on the drug charts prevent a detailed report about the drug’s benefits and risks during pregnancy. Your doctor knows your specific situation and is always the best source for this information.
Pregnancy Risk Category
Pregnancy risk categories as defined by the Food and Drug Administration (FDA) are assigned to prescription drugs and appear on the drug’s label (prescribing information). Each lettered category A, B, C, D and X describes potential risks for the drug to cause harmful effects to an unborn baby (fetus).
Doctors, pharmacists and other health -care providers use the risk category as one of their resources when advising pregnant women about drugs.
Category letters and definitions include:
• Category A: No evidence of risk exists. Adequate and well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities.
• Category B: The risk of fetal harm is possible but remote. Animal studies have revealed no evidence of harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women, or animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to show a risk to the fetus.
• Category C: Fetal risk can’t be ruled out. Animal studies have shown an adverse effect, and there are no adequate and well-controlled studies in pregnant women, or no animal studies have been conducted, and there are no adequate and well-controlled studies in pregnant women.
• Category D: Positive evidence of fetal risk exists, but, potential benefits from the drug may outweigh the risk. For example, the drug may be acceptable in a life-threatening situation or serious disease if safer drugs can’t be used or are ineffective. Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus.
• Category X: Contraindicated during pregnancy. Adequate well-controlled or observational studies in animals or preg-nant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or who may become pregnant.
• Category NR: Not rated.
Pregnancy & FDA Drug Labeling
The FDA issued new guidelines in 2014 that require details on prescription drug labels about the drug’s risks and benefits in pregnancy (and in breast-feeding). This additional detail will eventually replace the current letters A, B, C, D or X used on drug labels to categorize risk.
The new guidelines took effect in 2015 for new drugs, but drug manufacturers of existing drugs (FDA-approved since 2001) have several years to revise their labels.
During this drug label transition period (2015 to about 2020), doctors, pharmacists, other healthcare providers and pregnant women who are discussing the use of a drug may find:
1. Label has the current pregnancy risk category A, B, C, D or X (see above for definition).
2. New type of label with detailed information (as explained in next column).
3. Label on a drug approved prior to 2001 may have the current pregnancy risk category definition, but it will not include the associated letter—A, B, C, D or X.
4. Nonprescription drugs are not included in the guidelines. Their pregnancy labeling often states “ask a health professional before use.” Some may also list a specific warning.
New Label Details
The Pregnancy portion of the revised drug label will have these subsections:
• Pregnancy Exposure Registry: This is shown if a registry (see below) exists for the drug. It includes the telephone number of the registry and how to enroll.
• Fetal Risk Summary: This section provides information about the likelihood of fetal problems attributed to drug use and if this information is based on animal or human (or both) studies.
• Clinical Considerations: This section provides information on prescribing (e.g., dosage adjustment), education (e.g., about risks to mother and fetus from disease being treated) and counseling.
• Data: This section will provide back-ground on how the information in Fetal Risk Summary and Clinical Considerations was determined.
Pregnancy Exposure Registry
Pregnancy Exposure Registries are research studies that collect information from women who take prescription drugs or vaccines during pregnancy. Pregnancy registries help women and their doctors learn more about which drugs are safe to take during pregnancy.
The FDA does not run pregnancy studies, but it keeps a list of all registries. To see if there is a registry for your drug. go to www.fda.gov/pregnancyregistries.
Enrolling in a registry involves a few interviews, both during and after your pregnancy. The information collected in these interviews, as well as the fact of your participation, will be kept confidential. Some registries may ask that you enroll through your doctor or healthcare provider.
Ask your doctor about a Pregnancy Exposure Registry if you are pregnant and are taking any prescription drugs.