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Qutenza and Pregnancy

The FDA has classified Qutenza (capsaicin 8% patch) as a pregnancy Category B medication, meaning that the drug does not appear to pose a significant risk to a developing fetus. Animal studies have not shown that the medication will cause any significant risks. However, make sure to talk to your healthcare provider before using this medication during pregnancy.

I'm Pregnant -- Can I Use Qutenza?

Qutenza™ (capsaicin 8% patch) is a prescription medication used to treat pain that occurs after a case of shingles (a condition known as postherpetic neuralgia). Based on the results of animal studies, this medication appears to pose little risk to a developing fetus.

What Is Pregnancy Category B?

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 B is given to medicines that have not been adequately studied in pregnant humans, but do not appear to cause harm to the fetus in animal studies. Medications that have been shown to be safe for use in pregnancy in humans (but have caused problems in laboratory animals) are also given a Category B rating.
When Qutenza patches (or a liquid form of Qutenza) were applied to pregnant rabbits and rats at very high doses (up to 37 times the equivalent dosage used in humans), the drug did not appear to cause birth defects or any other problems.
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 B medicine should be given to a pregnant woman only if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.

Pregnancy and Qutenza: Final Thoughts

If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. Your healthcare provider will consider both the benefits and risks of using Qutenza before making a recommendation for your particular situation.
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