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Zyclara and Pregnancy

When the active ingredient in Zyclara was given in high doses to pregnant animals, it caused a number of problems, including bone problems, low fetal weight, and protruding tongues. Due to these risks, the FDA classified Zyclara as a pregnancy Category C medicine, meaning it may not be safe for use during pregnancy. However, there may be times where the benefits of the drug outweigh the risks.

Can Pregnant Women Use Zyclara?

Zyclara® (imiquimod cream) is a prescription medication used to treat a precancerous skin condition known as actinic keratosis or solar keratosis. It is also approved to treat genital warts and perianal warts. It is unclear if this medication is safe for use during pregnancy, as the full risks are currently unknown.

What Is 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 used during pregnancy. Zyclara is classified as a pregnancy Category C drug.
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm 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.
When given to pregnant animals at very high doses (by mouth or intravenously), imiquimod, the active ingredient in Zyclara, caused a few different problems, such as:
  • Increased miscarriages
  • Low fetal weight
  • Delayed bone hardening
  • Bent limb bones
  • Exencephaly, a problem where the brain develops outside of the skull
  • Protruding tongues
  • Low-set ears.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
Keep in mind that with normal skin use by the mother, the fetus would be exposed to a very small amount of the drug. In the few cases of fetal exposure to imiquimod due to maternal use of the skin cream, no problems were seen.
Pregnancy and Pain

Zyclara Medication Information

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