Ziana Acne Medicine & Pregnancy
Ziana is a registered trademark of the Medicis company for a combination of clindamycin and tretinoin. It is a topical gel that is used to treat acne vulgaris. The recommendation for women who are or plan to become pregnant is to consult their physicians before using the drug.
The FDA approved use of Ziana for acne vulgaris in 2006. At the time of its initial release, it had a Pregnancy Category C rating. Category C drugs have not had a well-controlled trial for safety in pregnant women. This means that the FDA does not recommend for or against this drug in pregnant mothers and leaves the decision to a woman and her physician.
While human trials have not been performed for Ziana safety in pregnancy, there have been animal trials for pregnancy. Animal trials do not necessarily represent what data will be in humans and therefore are only suggestive of what effects a drug will truly have. According to the official Ziana product information, the drug was tolerated in pregnant rabbits and their offspring at 12 times the recommended dose for adults. These rabbits were treated topically for two weeks prior to fertilization and during pregnancy and monitored through 18 days in gestation.
Additionally, the component medications, clindamycin and tretinoin have been tested in animals. While clindamycin has been tolerated in animal models of pregnancy, the data on tretinoin suggests that further testing is needed. According to the official Ziana product information, in a trial with 40 times the recommended topical dose of tretinoin on pregnant rabbits, there was a detectable increase in adverse effects in the newborn rabbits.
Ziana has not been tested for appearance in breast milk of nursing mothers, however clindamycin has been detected in breast milk. Therefore, it is suggested by the FDA that nursing mothers choose either to discontinue the drug or to discontinue nursing.
If a woman is, or plans to be, pregnant, she should consult her physician before taking Ziana. The drug should be prescribed if the potential benefit of the drug outweighs the risk to a fetus. Additionally, as data from human trials becomes available, the FDA Pregnancy Class rating can potentially change from C. Mothers and physicians should review the data when it becomes available.
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