How Do Health Care Professionals Determine Medication Safety For Pregnant Women?
A pregnant woman visits her health care provider or enters a hospital...it is determined she needs medication treatment...but what do health care providers do when a pregnant woman needs medication because, ideally, pregnant women should avoid medications? When faced with the challenge of determining medication safety and treatment strategies for pregnant women health care providers turn to the U.S. Food and Drug Administration (FDA) pregnancy risk categories. The FDA established these categories to avoid medication induced pregnancy risk and birth defects as well as help health care providers determine the appropriate medication treatment regimens for pregnant women.
What are the FDA pregnancy risk categories, what do they mean and what are examples of commonly prescribed medications in each pregnancy risk category?
Pregnancy Risk Category A - Human clinical studies in pregnant women show no risk.
Examples of commonly prescribed medications in this category include: levothyroxine (Synthroid) and liothyronine (Cytomel).
Pregnancy Risk Category B - Clinical animal-reproduction studies have not shown pregnancy risk. However there are no clinical studies in pregnant women.
Examples of commonly prescribed medications in this category include: oxycodone (Roxicodone), metformin (Glucophage), ondansetron (Zofran) and amoxicillin (Moxatag).
Pregnancy Risk Category C - Clinical studies cannot rule out pregnancy risk, i.e. clinical animal-reproduction studies have shown adverse effects on the fetus. There are no clinical studies in pregnant women.
Examples of commonly prescribed medications in this category include: fluconazole (Diflucan), albuterol (Ventolin), sertraline (Zoloft), fluoxetine (Prozac), bisoprolol (Zebeta) and quetiapine (Seroquel).
Pregnancy Risk Category D - Clinical studies demonstrate positive evidence of pregnancy risk, however medications in this category may be administered to pregnant women if they are in a life-threatening situation, there are NO other medications available and/or other medications have been determined ineffective.
Examples of commonly prescribed medications in this category include: lithium (Lithobid), phenytoin (Dilantin), lorazepam (Ativan), lisinopril (Zestril) and clonazepam (Klonopin).
Pregnancy Risk Category X - Clinical studies in animals and/or humans have shown fetal adverse effects and/or there is evidence of fetal risk based on experience, or both. Medications in this category are contraindicated in pregnant women and women who may become pregnant. Examples of commonly prescribed medications in this category include: isotretinoin (Accutane) and thalidomide (Thalmid).
How do health care professionals use the aforementioned categories to determine if a medication is appropriate to use in pregnant women?
Health care professionals will first determine the pregnancy risk category of the medication in question. If the medication falls in pregnancy risk category A or pregnancy risk category X the answer is very straightforward.
Pregnancy risk category A medications will typically be administered to pregnant women, while pregnancy risk category X medications will typically be avoided.
If the medication is in pregnancy risk category D it will typically only be administered to a pregnant woman if her life is in danger or if other medications failed to treat the pregnant woman.
However, if the medication falls into pregnancy risk category B or C the answer is not so straightforward. In these cases, the health care professionals use their professional judgment to determine if the medication is appropriate to use. They will typically weigh the medication benefits versus the medication risks, i.e. will the medication benefits to the mother justify the potential risk to the fetus...if the benefits outweigh the risks the medication will be given...if the risks outweigh the benefits the medication will typically be avoided. Determining if a medication should be used in a pregnant woman is not an easy task.
However, medication pregnancy risk categories can guide health care professionals in their decision making process and allow them to treat pregnant women with medications effectively and, most importantly, safely.
Hello, my name is Dr. Macera, PharmD, RPh. I am a clinical pharmacist with over a decade of experience practicing and studying at such institutions as: Harvard University, Northeastern University and Dana-Farber Cancer Institute. I hope to both educate and inform through compelling blog posts.