Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation


Pregnancy
Studies in animals (rats and rabbits) have shown reproductive toxicity, including malformations (see sections 4.3 and 5.3). Inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. The potential for human risk in pregnancy is unknown but cannot be excluded. Celecoxib, as with other medicinal products inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester.

During the second or third trimester of pregnancy, NSAIDs including celecoxib may cause fetal renal dysfunction which may result in reduction of amniotic fluid volume or oligohydramnios in severe 
cases. Such effects may occur shortly after treatment initiation and are usually reversible upon discontinuation.

Celecoxib is contraindicated in pregnancy and in women who can become pregnant (see sections 4.3 and 4.4). If a woman becomes pregnant during treatment, celecoxib should be discontinued.

Breast-feeding

Celecoxib is excreted in the milk of lactating rats at concentrations similar to those in plasma.
Administration of celecoxib to a limited number of lactating women has shown a very low transfer of celecoxib into breast milk. Women who take Celcox should not breastfeed.

Fertility

Based on the mechanism of action, the use of NSAIDs, including celecoxib, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.