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June 29, 2007
Common depression drugs taken during pregnancy present little risk of birth defects, two large studies say. The drugs include Prozac, Paxil, Zoloft and others that act in a similar way. In all, the studies included 19,471 newborns with birth defects and 9,952 without them. Researchers asked mothers what drugs they took during the first three months of pregnancy. The studies showed no overall increase in risk with antidepressant drugs. Risk was higher only for specific, rare birth defects. The Associated Press reported on the studies June 28. They were in the New England Journal of Medicine.
By Diana Post, M.D.
Harvard Medical School
What Is the Doctor's Reaction?
Using certain medicines for depression during pregnancy does not seem to significantly increase the risk for most birth defects. This is the conclusion from two new studies published this week in the New England Journal of Medicine.
We know for sure that some medicines are not safe to take during pregnancy. Unfortunately, we often don't have enough information to know whether a specific drug is safe or not.
The U.S. Food and Drug Administration (FDA) does not yet require studies on safety in pregnancy when it approves new drugs. So physicians are prescribing drugs for women during pregnancy without always knowing much about their safety.
The two studies that have just come out looked at birth defects when women take certain antidepressant medicines during the first three months of pregnancy. The focus of the research was the group of drugs known as SSRIs (selective serotonin reuptake inhibitors). These medicines are the ones most often used to treat depression and anxiety. The best known include Prozac (fluoxetine), Zoloft (sertraline) and Paxil (paroxetine).
Depression is a common problem. It is estimated that about 10% of pregnant women are affected. Many of these women with depression need medicine during pregnancy.
Early studies showed that SSRI medicines were not associated with large increases in major birth defects. However, in the last few years some studies have suggested that at least some of these drugs are associated with small but increased risks of certain birth defects. So patients with serious depression and their doctors were left without enough information to make very difficult choices.
These two new studies were carried out to try to answer the questions about SSRI use during pregnancy. Together, they provide some reassurance to women and their doctors.
f One of the two studies found a very small increased risk of a few rare birth defects with SSRI use during early pregnancy. The increase in risk was minimal. The other study found some individual SSRI drugs to be associated with certain very rare and specific birth defects. These risks were also very small. Further studies may help define these better.
What Changes Can I Make Now?
If you are planning a pregnancy in the near future, talk with your doctor now about the safety of your medicines. If at all possible, you want to be off all potentially dangerous medicines before you try to get pregnant. Don't forget to include herbs, vitamins and supplements in your discussions -- they too might have potential risks. Remember, over-the-counter drugs are also medicines and should be reviewed.
If you are already pregnant and taking or considering medicines, talk with your doctor. Review the drug safety information. Make sure a medicine is both necessary and safe to take when pregnant.
Remember that you can do many other things to help ensure the health of your new baby.
Get prenatal care from your doctor, midwife or nurse. Check to make sure you are immune to German measles before becoming pregnant. Get an HIV test before your pregnancy. Take prenatal vitamins with folic acid as soon as you start thinking about a future pregnancy. This can help prevent birth defects. Avoid eating certain fish that might have high mercury levels (such as shark, swordfish, tilefish and some tuna). Mercury has been associated with birth defects. Eat a well-balanced diet. Don't smoke, drink alcohol or take illegal drugs. Wear your seatbelt! Talk to your clinician about specific ways of preventing infections such as listeria and toxoplasmosis, which can be passed from the mother to the fetus.What Can I Expect Looking to the Future?
We need more studies to look at drug safety during pregnancy. I hope the federal government and other funding groups will support new studies. That will help doctors and patients make more informed choices.
I think that programs to track and report on possible connections between medicines and birth defects should be set up across the country. These could provide further information about drug safety and help protect against birth defects. In addition, the FDA might redesign its drug approval process to require studies on safety of new drugs in pregnancy before approving a new drug.
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