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Protopic and Pregnancy

Based on the results of studying animals that are pregnant, Protopic was given a Category C rating by the Food and Drug Administration. This means it caused problems for the animal fetuses and might also cause problems in humans. These included an increased risk for birth defects as well as miscarriage. Protopic might be given to a woman during pregnancy, provided the benefits outweighed the risks.

Can Pregnant Women Use Protopic?

Protopic® (tacrolimus ointment) is a topical prescription medication approved to treat moderate-to-severe atopic dermatitis, a skin condition sometimes referred to as eczema. Based on animal studies, this medication may not be safe for use during pregnancy.
 

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 taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied 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.
 
Protopic has not been studied in pregnant women. Tacrolimus, the active ingredient in Protopic, caused miscarriage when given orally to pregnant rats and rabbits. In very high doses, it also increased the risk for birth defects in the animal fetuses.
 
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
 
The use of oral tacrolimus during pregnancy has been associated with premature birth, as well as kidney problems and increased blood potassium levels (hyperkalemia) in newborn infants. In most cases, the mother was taking the medication after a kidney transplant. It should be noted that there are also many cases of the medicine being used by pregnant women without causing these problems.
 
In addition, Protopic is a topical medicine, which means it is applied directly to the skin. As a result, very little of it is expected to be absorbed into the body after normal use. However, certain factors could increase the amount of medicine absorbed through the skin, such as using the medicine on large areas of skin or on skin that has open sores, or using Protopic more often than recommended. Also, people with certain skin conditions may absorb more of the drug than normally expected.
 
Pregnancy and Pain

Protopic Medication Information

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