Is Otezla safe to take during pregnancy?

It is unknown if Otezla is safe to take during pregnancy because Otezla has not been used in many pregnant women, but so far there is no indication that Otezla increases the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies conducted in monkeys showed an increase in spontaneous abortion or fetal death when up to 2.1 times the maximum recommended human dose (MRHD) was used, but no increase when 1.4 times the MRHD was given. In mice, no increased risk or birth defects were noted at 4 times the MRHD. However, it is not known how accurately data obtained from animal trials translate to humans.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy (call 1-877-311-8972). Animal studies have shown that Otezla crosses the placenta and is present in the milk of lactating animals, so it is likely to do the same in humans.

Tell your doctor if you are breastfeeding, pregnant, or intending to become pregnant before taking Otezla. If you inadvertently become pregnant while taking Otezla, enroll on the registry that monitors pregnancy outcomes (call 1-877-311-8972).

Otezla is a PDE4 inhibitor that may be used to treat adults with plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s Disease. It may also be used to treat children 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.