Pennsaid and Pregnancy
Because Pennsaid (diclofenac sodium topical solution) has not been studied in pregnant women, the full risks are not known. The FDA classifies it as a pregnancy Category C and Category D medication, which means it may be prescribed under certain circumstances. It's important to avoid this product near the end of pregnancy if possible -- this is when the most serious adverse effects typically occur.
Is It Safe to Use Pennsaid If I'm Pregnant?Pennsaid® (diclofenac sodium topical solution) is a prescription arthritis medication. It may present some risks to the fetus when taken during pregnancy, although the full risks are currently unknown.
What Are Pregnancy Categories C and D?
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. Medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Pregnancy Category D is given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks.
In general, animal studies have failed to show significant risks associated with the use of diclofenac (the active ingredient in Pennsaid), although one study suggested that there may be a link between diclofenac exposure and cleft palate in mice. Pennsaid has not been studied in pregnant women.