Acamprosate Pregnancy and Breastfeeding Warnings

Acamprosate is also known as: Campral

Acamprosate Pregnancy Warnings

Studies have shown acamprosate to be teratogenic in rats when administered in doses equivalent to human doses, and in rabbits when administered in doses equivalent to three times the human dose.

Acamprosate has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of genotoxicity, but have revealed possible cases of teratogenicity. However, it is difficult to ascertain if these cases were a result of acamprosate therapy or ethyl alcohol ingestion. Animal studies have also shown an increased incidence of still-born fetuses. There are no controlled data in human pregnancy. The manufacturer recommends acamprosate be used during pregnancy only when the potential benefits outweigh the potential risks to the fetus.

Acamprosate Breastfeeding Warnings

There are no data on the excretion of acamprosate into human milk. The manufacturer recommends the use of caution when administering acamprosate to nursing women.

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