Dynastat Use In Pregnancy & Lactation

Fertility: Based on the mechanism of action, the use of NSAIDs may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including parecoxib, should be considered.
Pregnancy: Parecoxib is suspected to cause serious birth defects when administered during the last trimester of pregnancy because as with other medicinal products known to inhibit prostaglandin, it may cause premature closure of the ductus arteriosus or uterine inertia (see Contraindications and Pharmacology: Pharmacodynamics under Actions).
Dynastat is contraindicated (see Contraindications) in the last trimester of pregnancy.
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. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Dynastat is not recommended in women attempting to conceive (see Precautions and Pharmacology: Pharmacodynamics under Actions).
There are no adequate data from the use of parecoxib in pregnant women or during labour. Studies in animals have shown reproductive toxicity (see Pharmacology: Pharmacodynamics under Actions). The potential risk for humans is unknown. Dynastat should not be used during the first two trimesters of pregnancy unless clearly necessary (i.e., the potential benefit to the patient outweighs the potential risk to the foetus).
Use of NSAIDs at about 20 weeks gestation or later in pregnancy may cause foetal renal dysfunction leading to oligohydramnios and in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation.
Lactation: Administration of a single dose of parecoxib to lactating women resulted in the transfer of a relatively small amount of parecoxib and its active metabolite into breast milk, and this resulted in a low relative dose for the infant (less than 1% of the weight-adjusted maternal dose). Dynastat must not be administered to women who breast-feed (see Contraindications).