Locoa Use In Pregnancy & Lactation

Esflurbiprofen (LOCOA) cannot be used in women in late pregnancy. A study in rats in late pregnancy showed deaths of dams, delayed delivery, reduced fertility rates, and increased stillbirths with less than the plasma esflurbiprofen level (AUC) equivalent to that yielded by the use of 2 patches of Esflurbiprofen (LOCOA) in humans (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Esflurbiprofen (LOCOA) should be administered to pregnant women (excluding those in their third trimester) or women who may be pregnant only when the therapeutic benefits are considered to outweigh the risks. [Safety has not been established in pregnant women.] If such administration is deemed necessary, caution should be exercised such as limiting to the minimum effective use and monitoring amniotic fluid as necessary around 20 weeks gestation or later in pregnancy. Renal impairment and decreased urine output in foetuses as well as accompanying oligohydramnios have been reported following use of cyclooxygenase inhibitors.
The use of Esflurbiprofen (LOCOA) should be avoided in lactating women. If such use is deemed necessary, they should use it after the patient has stopped lactating. [An animal study (rats) showed excretion of esflurbiprofen into the milk and restricted increase in body weight in offspring of dams with approximately 3 times the plasma level (AUC) yielded by the use of 2 patches of Esflurbiprofen (LOCOA) in humans (see Pharmacology: Toxicology: Preclinical safety data under Actions)].
Constriction of the fetal ductus arteriosus has been reported in women in late pregnancy using other topical nonsteroidal anti-inflammatory analgesics.
Temporary infertility has been reported in women after long term use of nonsteroidal anti-inflammatory analgesics.