Is Solaraze Gel Safe During Pregnancy?
Solaraze® Gel (
diclofenac gel) is a prescription medication used to treat a precancerous skin condition known as actinic keratosis or solar keratosis. In general, this medication is relatively safe for use during pregnancy, although the full risks are currently unknown.
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 general, animal studies have failed to show significant risks associated with the use of
diclofenac (the active ingredient in Solaraze Gel). The medication has not been studied in pregnant humans.
NSAIDs and Pregnancy Complications
Even though Solaraze Gel was given a pregnancy Category B rating, other forms of diclofenac (even other skin products) were given a more serious rating of pregnancy Category C. It is not entirely clear why the different ratings were given.
Diclofenac is a nonsteroidal anti-inflammatory drug (
NSAID). Even though Solaraze Gel is applied to the skin, some of the medication is absorbed into the bloodstream and passed through the placenta to the fetus. Studies have demonstrated that NSAIDs (including diclofenac) can cause certain
problems during pregnancy in humans, including:
- Increased risk of miscarriage
- Possible increased risk of birth defects (although this risk appears to be small)
- Prolonged pregnancy (as NSAIDs inhibit the prostaglandins that help stimulate labor)
- Poor kidney function in the fetus
- Premature closure of the ductus arteriosus (a potentially fatal heart problem) in the fetus
- Persistent pulmonary hypertension (a very serious lung problem) in the newborn.
The most serious effects of NSAID use occur near the end of pregnancy. It should also be noted that women trying to become pregnant should avoid NSAIDs, as they appear to interfere with the implantation process.
