Women often need to continue their medications during pregnancy. Many of these are prescription, but some are over-the-counter drugs.
Medical trials usually exclude pregnant women, so data on medication safety in pregnancy is limited and primarily based on registries and epidemiological studies, which have several limitations.
Prior to 2015, FDA risk categories ranged from category A (no risk) to category X (evidence of fetal abnormalities in animals or humans). Now there is one general risk summary and 3 subheadings.
Check with Your Healthcare Provider
Some conditions (such as asthma, epilepsy, or high blood pressure) require ongoing medical treatment for the safety of a pregnant woman and her baby. Sometimes, a new medication can be prescribed to help manage the condition. Generally, the benefit to the pregnant woman outweighs the possible risks. However, not all drugs are safe for use in pregnancy and many prescription medications have not been studied in pregnant women.
CDC and partners are working to learn more about the safety of medicines before, during, and after pregnancy. This includes using existing resources like spontaneous reporting, primary cohort and case control studies, pregnancy exposure registries, and electronic health data repurposed for research purposes. These studies provide better information that supports a woman’s ability to weigh the benefits and risks of medications in her own unique situation.
Most short-term or common medications – including allergy pills, cold medicine, pain relievers, and some antidepressants – are considered safe for most women to take. However, some medications can increase the risk of a birth defect when taken in early pregnancy. Because of this, it’s important that a woman check with her healthcare provider before taking any medication if she is thinking about getting pregnant or has recently found out she is pregnant. The healthcare provider can then determine if the medication is likely safe or should be discontinued.
Read the Label
Nearly all women take medication at some point during pregnancy, whether they are prescribed or over-the-counter. Some medications can be dangerous for the unborn baby. However, many drugs are safe if taken as recommended by the doctor.
Health professionals must weigh the benefits of taking a medication against the possible harm to the fetus and mother. The balance is often not clear. That is why it is important for people to check with their doctor before becoming pregnant, and to ask questions when taking medications.
Some medications have been well studied in pregnancy, while others are not. The FDA has a system for classifying medications in terms of their safety during pregnancy. Categories A and B are considered safe, category C is unclear, category D means that fetal risks have been identified in animal studies but not in human studies, and category X is contraindicated for use in pregnancy. The system is not foolproof, but it is a good place to start.
The Pregnancy Drug Labeling Rule (PLLR) that is expected to be implemented in 2016 will change the way that information about medication use in pregnancy is presented on the drug label. This will replace the arbitrary and often misinterpreted letter-based categorization system with a narrative summary of the risks to the mother and fetus, clinical considerations, and data from the pregnancy exposure registry.
Take the Smallest Effective Dose
Whether the medication is prescribed or over-the-counter, most medications will have some risk to the unborn child. Taking the smallest dose possible for the longest time is ideal to minimize that risk. It is also important to take the medication as instructed on the label and not go over the dosage.
Some drugs have a greater effect on the fetus than others, and these effects may vary between individuals. In addition, a woman’s health condition may require her to take the medication anyway. The risks must be weighed against the benefits of the medication for the mother and the baby.
Many women take multiple medications, including over-the-counter and dietary supplements. This complicates counseling on drug use during pregnancy. Many dietary and herbal products may interact with prescription drugs, and even some vitamins can have adverse side effects when taken during pregnancy.
The unique physiology of pregnancy affects the absorption, distribution, metabolism and elimination of drugs. This is due to increased blood flow, increased hepatic enzyme activity, and the presence of estrogen and progesterone.
The fetal safety of medications in pregnancy is based on human and animal studies, as well as a history of adverse outcomes related to the drug in pregnant women. The FDA classifies medications based on this knowledge. Prior to 2015, the FDA used a letter system that ranged from category A (no evidence of harm) to category X (evidence of fetal abnormality in human and animal studies). The new system replaces the letters and is easier to understand.
Avoid Overdosing
Pregnancy is a time of excitement, but it can also be scary for many women who need medication. It is important to talk to your doctor about any medications you take or may want to consider taking while pregnant. Many medical conditions that are treated with drugs, such as chronic illnesses like asthma or high blood pressure, need to be managed during pregnancy. Medications can help control symptoms that can harm both the mother and baby, such as nausea and vomiting, fever, or swelling.
There are some medications that are not considered safe to take while pregnant, including NSAIDs (such as aspirin and ibuprofen) and antidepressants such as paroxetine. However, many women who need these medications for their health or for treatment of other medical conditions will not be able to stop taking them even if they are pregnant. The benefits of these drugs to the mother must be weighed against the risks that they could have to the fetus.
In December 2014, the Food and Drug Administration changed how it classifies both over-the-counter and prescription drugs in terms of their safety during pregnancy. The new PLLR (Pregnancy Low-to-Moderate Risk) system gives more information to physicians and consumers about the possible risks of a given drug in pregnancy. The new label includes a fetal risk summary, a list of clinical considerations that should be reviewed before prescribing the drug to a woman who is or might become pregnant, and a data section that provides detailed information about the available evidence.
