Drugs to Take and to Avoid
Some pills you pop, whether prescription or over-the-counter, may have dire consequences for your developing baby. Never assume anything is safe to take unless you speak to your doctor first. Many medications have not been studied extensively enough in pregnant women to determine whether they cause harm to the fetus. Therefore, it is vital to speak with your doctor before taking any type of medication. Taking some type of medication during pregnancy is not uncommon. The American Academy of Family Physicians estimate that more than 80 percent of pregnant women take over-the-counter or prescription drugs during pregnancy.
There is much controversy and plenty of gray area when it comes to the safety of prescription medications and pregnancy. There is no definitive answer on whether many medications are safe to use during pregnancy or not. Many do not have extensive, long-term studies that can give us clearcut answers. The reality is that women can get sick during pregnancy, and many enter pregnancy with chronic conditions that require treatment with prescription medications.
If you plan to get pregnant or become pregnant and are taking prescription medications, do not stop taking them without speaking with your doctor first. Many medications cannot be stopped abruptly without adverse effects and must be discontinued gradually.
Withholding medication during pregnancy is not always the answer, and sometimes there is more of a health risk to leaving a condition untreated. Medication use during pregnancy is common, and the number of a woman's prescriptions tends to rise with her age. The best that doctors can do is use the safest drug and safest dose possible so that all patients, including pregnant women, can receive the treatment they need.
It is absolutely vital that you speak with your doctor about all prescription medications you may be taking before you begin trying to conceive. Some medications that your doctor prescribed before you became pregnant may not be safe once you become pregnant. Your doctor can tell you what is safe and not safe to take and can make substitutions if necessary. Never take any prescription medication during pregnancy without speaking with your doctor first. If your doctor has prescribed a medication or deemed one safe to take, it is important to take the medication exactly as your doctor prescribes.
The FDA Ranking System
The FDA evaluates all available research studies that test the safety and efficacy of new drugs. Drugs are first tested on animals to determine their initial level of safety. Once they are deemed sufficiently safe, the drug is then tested on humans. These are controlled studies, in which one group takes the actual drug and another (the control group) takes a placebo. The problem with drugs and pregnancy is that due to the possible harm to the mother and fetus, they cannot be tested on pregnant women. Additionally, some drugs that are considered safe to take early in the first trimester may turn out to be harmful during the last trimester of pregnancy as the mother's body goes through physiological changes.
Some drugs are given an unclear safety rating when they are first made available, but they later receive a safe rating because many pregnant women used the drug during pregnancy with no harmful effects. To deal with this rating dilemma, the FDA created a rating system that assigns a safety category of A, B, C, D, or X to all over-the-counter and prescription drugs. These categories represent essential information about a drug's safety during pregnancy. This rating is required on the label of all drugs. Although the rating system has been under some scrutiny, it helps pregnant women and doctors to make important decisions about which drugs may be safe and what may not be safe to take.
The following is the ranking system of the FDA:
Category A — Controlled studies have shown no risk. Adequate, well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester of pregnancy. Unfortunately, very few drugs fall into this category. Prenatal vitamins have a category A rating.
Category B — Animal studies revealed no evidence of harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women. Also in category B are drugs that have been shown to have an adverse effect in animal studies, but adequate and well-controlled studies in pregnant women have failed to demonstrate risk to the fetus.
Category C — Risks cannot be ruled out. Adequate, well-controlled human studies are lacking, and animal studies have shown a risk to the fetus or are lacking as well. A category C implies that the drug may or may not be safe to take.
Category D — Positive evidence of risk exists. Studies in humans, both controlled or observational (noncontrolled) studies, resulted in harm to the fetus. Nevertheless, potential benefits from the use of the drug may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective (such as cancer treatment).
Category X — The drug is contraindicated in pregnancy. Studies prove that the drug should never be used in any stage of pregnancy. Tests demonstrate positive evidence of fetal abnormalities or risks, which clearly outweigh any possible benefit to the patient.
The bottom line is that all decisions regarding drug treatment during pregnancy should be made and monitored by your doctor.
The FDA continually monitors the safety of drugs during pregnancy. Drug manufacturers are required to do their part by collecting feedback from pregnant women who are taking their drugs and to report their findings to the FDA.