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Animal studies on pregnancy and methadone showed that high doses of the medication increased the risk of birth defects. However, in some instances, methadone use during pregnancy is safer than using heroin, so using this drug to treat opioid addiction is often considered acceptable for pregnant women. The same is not true when this medicine is used to treat pain.

Is Methadone Safe During Pregnancy?

Methadone hydrochloride (Diskets®, Dolophine®, Methadose®) is a narcotic used to treat pain and opioid addiction. Although there may be some risks when using this medication during pregnancy, in many cases, the potential benefits outweigh those risks.

Methadone and Pregnancy Category C

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 C is given to medicines that have not been studied adequately in pregnant humans but do appear to cause harm to the fetus in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
In general, survey-type studies (usually the only type of studies of medications that can be ethically performed in pregnant women) have failed to show any significant association between methadone use and birth defects.
Studies also suggest that treatment with methadone is better for both the pregnant woman and the fetus than continued abuse of heroin or other illicit substances. Therefore, using methadone to treat opioid addiction is often considered acceptable for pregnant women because it is safer than the alternative of continued drug abuse.
Methadone use for pain is less appropriate, however, as there may be other alternatives with lesser risk.
In some animal studies, very high doses of methadone use during pregnancy appeared to increase the risk of birth defects. However, these doses were usually high enough to be fatal to the pregnant animals.
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Last reviewed by: Kristi Monson, PharmD;
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