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Women should not take Arthrotec (diclofenac/misoprostol) during pregnancy, as this drug can cause birth defects, an abortion, or serious heart or lung problems. Due to these potentially serious problems, this drug is considered a pregnancy Category X medicine. To avoid dangerous complications, a woman must take a pregnancy test before taking Arthrotec and use effective birth control during treatment.

Can Pregnant Women Take Arthrotec?

Arthrotec® (diclofenac/misoprostol) is a prescription medication that contains a combination of diclofenac sodium (Voltaren®, Voltaren®-XR) and misoprostol (Cytotec®). The medication is quite dangerous for women who are pregnant, as it can cause abortion, premature birth, and birth defects. Due to these potential risks, Arthrotec has been given a pregnancy Category X classification.

What Is Pregnancy Category X?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in human use of the drug. With this category, the potential risks clearly outweigh the potential benefits.
Diclofenac, one of the medications in Arthrotec, and other nonsteroidal anti-inflammatory drugs (NSAIDs) can cause a variety of problems if used by a pregnant woman near the end of pregnancy. These problems include pulmonary hypertension (a serious lung problem) and premature closure of the ductus arteriosus (a serious heart problem). For this reason, it is generally recommended that pregnant women not take NSAIDs during late pregnancy (usually week 30 and later).
In addition, the misoprostol component of Arthrotec is also dangerous when taken during pregnancy, as it may harm a woman or her unborn child. The medication can cause uterine contractions, potentially leading to abortion or premature birth. In some cases, the abortion may be incomplete, meaning some of the fetal tissue remains in the womb, which could cause dangerous bleeding that requires hospitalization and surgery.
When given after the eighth week of pregnancy, the drug has been reported to cause tearing of the uterus (known as uterine rupture). Uterine rupture can lead to severe bleeding and death of the unborn child or the mother.
Furthermore, misoprostol has been associated with birth defects when given to pregnant women in the first trimester. Some of these defects include fetal abnormalities of the skull, face, and extremities (arms and legs). It is not entirely clear if misoprostol was responsible for these problems, and in animal studies, the drug did not appear to cause birth defects. However, it is important to note that animals do not always respond to a medication in the same way as people.
If you are a woman of childbearing potential, your healthcare provider will make sure you are not pregnant by giving you a blood test within two weeks of beginning Arthrotec. You will begin treatment on the second or third day of your next menstrual period. You will need to use an effective form of birth control to prevent pregnancy during treatment and for at least one month after treatment ends. Your healthcare provider can help you choose an effective birth control for your individual situation.
You should know that any birth control method can fail. If you become pregnant while taking Arthrotec, stop taking the medicine and contact your healthcare provider right away.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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