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 LOCOA in humans (See Pharmacology: Toxicology: Preclinical safety data under Actions.)
LOCOA should be used in pregnant women (other than those in late pregnancy) or potentially pregnant women, only if therapeutic benefits are deemed to outweigh risks. [Safety has not been established in pregnant women.]
The use of 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 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.