Alprostadil (injectable and transurethral) Pregnancy Warnings
This drug is not indicated for use in women.
AU TGA pregnancy category: Not formally assigned to a pregnancy category
US FDA pregnancy category: C (suppositories)
US FDA pregnancy category: Not formally assigned to a pregnancy category (non-suppository formulations)
Comments: Male partners should use a condom during intercourse.
Animal studies have revealed evidence of embryotoxicity. There are no controlled data in human pregnancy.
This drug is chemically identical to prostaglandin E1 (PGE1), which occurs naturally in seminal fluid. Use of this drug may add to the amount of PGE1 present in the seminal fluid. Male partners should use a condom during intercourse to avoid vaginal irritation and risk of preterm delivery.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
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