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Gelnique and Pregnancy

The FDA has classified Gelnique (oxybutynin gel) as a pregnancy Category B medication, meaning that it is probably safe for use in pregnancy. Gelnique did not appear to cause birth defects, miscarriages, or any other problems when given to pregnant animals. However, because animals do not always respond to medications in the same way that humans do, make sure to talk to your healthcare provider if pregnancy occurs while you are taking this medication.

Is Gelnique Safe During Pregnancy?

Gelnique™ (oxybutynin gel) is a prescription skin gel approved to treat an overactive bladder. Based on the results of animal studies, this medication is probably safe for use in pregnancy, although the full risks are not currently known.

Pregnancy Category B

The U.S. Food and Drug Administration (FDA) uses a pregnancy 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.
In studies, giving oxybutynin (the active ingredient of the drug) to pregnant animals did not increase the risk of birth defects, miscarriages, 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 Gelnique: Final Thoughts

If you are pregnant or are thinking about becoming pregnant, let your healthcare provider know. He or she will consider the benefits and risks of taking this medication during pregnancy before making a recommendation in your particular situation.
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Gelnique Medication Information

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