FDA Pregnancy Drug Categories

After conception, a woman’s body reprograms its immune system to be weaker so as not to attack the new foreign object inside her.  Unfortunately, this means that pregnant women have an increased susceptibility to germs that could lead to illness.  But the conundrum is that the unborn baby is more vulnerable to the use of most substances than is a healthy adult.  Obstetricians advise pregnant women to stay away from foods that could cause sickness (such as cheese made from unpasteurized milk, sushi made with raw fish, and lunch meats that have not been heated to kill bacteria).  They also recommend expectant mothers to avoid people who may have contagious diseases, but this advice is not always realistic or practical - especially if the mother-to-be works outside the home or cares for school-age children.  Some women will endure the symptoms of a mild cold so as not to expose the developing fetus to a drug unnecessarily.  Yet what happens when a pregnant woman gets a serious illness or needs to be treated for pain after an injury or surgical procedure?

What is the Food and Drug Administration (FDA)?

The FDA is a governmental organization that, among other responsibilities, determines the safety and efficacy of medications, supplements, and food products. If you have ever seen the warning "These statements have not been evaluated by the FDA," it often means "consume at your own risk."

What are the pregnancy drug categories?

Certain substances that are safe for adults at recommended doses may not be safe for a child or unborn baby and others may harm a baby who is nursing. For this reason, the FDA considers pregnancy differently when evaluating a drug's safety. There are five drug categories related to pregnancy: A, B, C, D, and X.  However, in 1997, the FDA realized that many people interpreted these categories as if there were no room for error and so they began requiring more comprehensive information on labels.  The categories are still used as a general guideline.

Category A: Well-designed research specifically using pregnant women has demonstrated that the fetus is not at risk during any trimester (assuming that the drug is used correctly).

Category B: Although animal studies have indicated risk, research has not found any threat in human pregnancies; if no human studies have been done, no risk has been detected in studies on animals.  Slight risk to the fetus is possible but unlikely.

Category C: These drugs have not been sufficiently studied in human or animal populations.  The developing baby may be harmed, but the risk to the mother (and fetus) if the mother does not take the drug may outweigh the risk associated with fetal exposure.

Category D: Research has shown clear evidence of risk; however, these drugs may still be considered in extreme instances (for example, if the mother’s life is threatened or other, safer medications cannot control serious illness).

Category X: Like Category D drugs, these substances have been linked to birth defects and other abnormalities; however, the associated fetal problems outweigh the potential benefit to the mother and, for this reason, these drugs should be avoided during pregnancy at all costs.

Substances like alcohol, tobacco, marijuana, cocaine, crack, and heroin and other opiates can cause problems for a developing baby (Read Pregnancy and Substance Use: A Dangerous Combination).  Still, some drugs may be necessary to treat a recovering addict who is pregnant (Read Methadone and Suboxone During Pregnancy: Risks and Benefits).  If you or someone you know is pregnant and abusing substances, call eDrugRehab now for assistance!