Locoa Use In Pregnancy & Lactation

LOCOA cannot be used in women in the third trimester of 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 LOCOA in humans (see Contraindications and Pharmacology: Toxicology: Preclinical safety data under Actions).
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 for amniotic fluid and suspected findings of ductus arteriosus constriction as necessary, considering gestational weeks (around 20 weeks gestation or later in pregnancy) and administration periods. Renal impairment and decreased urine output in foetuses as well as accompanying oligohydramnios have been reported following use of cyclooxygenase inhibitors in pregnant women. In addition, ductus arteriosus constriction has been reported following use of cyclooxygenase inhibitors (products with expected systemic effects) in women in the second trimester.
When LOCOA is used to lactating women, continuation or discontinuation of lactating should be determined based on consideration of the potential therapeutic benefits and the benefits of 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 LOCOA in humans (see Pharmacology: Toxicology: Preclinical safety data under Actions)].
Constriction of the fetal ductus arteriosus has been reported in women in the third trimester of pregnancy using other topical nonsteroidal anti-inflammatory analgesics.
Temporary infertility has been reported in women after long term use of nonsteroidal anti-inflammatory analgesics.