Voltaren/Voltaren SR Use In Pregnancy & Lactation

Voltaren EC tablet/suppository: Pregnancy: The use of diclofenac in pregnant women has not been studied. Therefore, Voltaren should not be used during the first two trimesters of pregnancy unless the potential benefit to the mother outweighs the risk to the foetus. As with other NSAIDs, use of diclofenac during the third trimester of pregnancy is contraindicated owing to the possibility of uterine inertia and/or premature closure of the ductus arteriosus (see Contraindications). Animal studies have not shown any directly or indirectly harmful effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Lactation: Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, Voltaren should not be administered during breast-feeding in order to avoid undesirable effects in the infant.
Fertility: As with other NSAIDs, the use of Voltaren may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Voltaren should be considered.
Voltaren SR-FC tablet: Pregnancy: Inhibition of prostaglandin synthesis may have a negative impact on pregnancy and/or embryofetal development. Data from epidemiological studies suggest an elevated risk of miscarriage and of cardiac malformation and gastroschisis following administration of a prostaglandin synthetase inhibitor during early pregnancy. The risk is assumed to rise with the dose and the duration of therapy.
In animals, administration of a prostaglandin synthetase inhibitor has been shown to result in increased pre-implantation and post-implantation loss and embryofetal lethality. In addition, increased incidences of various malformations, including cardiovascular malformations, have been reported in animals given a prostaglandin synthetase inhibitor during organogenesis (see Pharmacology: Toxicology: Preclinical safety data under Actions).
First/second trimester: During the first and second trimesters of pregnancy, diclofenac should not be given unless absolutely necessary. If diclofenac is used by a woman attempting to conceive, or during the first or second trimesters of pregnancy, the dose should be kept as low - and the duration of treatment as short - as possible.
Oligohydramnios/neonatal renal impairment: Use of NSAIDs in the 20^th week of pregnancy or later may lead to fetal renal impairment, which may cause oligohydramnios and, in some cases, neonatal renal impairment. These adverse effects occur, on average, after days to weeks of treatment, although in rare cases oligohydramnios has been reported as early as 48 hours after initiation of NSAID treatment. Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some post-marketing cases of neonatal renal impairment invasive procedures such as exchange transfusion or dialysis were required. Consider ultrasound monitoring of the amniotic fluid if Voltaren treatment lasts longer than 48 hours. Discontinue Voltaren if oligohydramnios occurs and follow up according to clinical practice.
Third trimester: Diclofenac is contraindicated during the third trimester of pregnancy.
All prostaglandin synthetase inhibitors may expose the fetus to the following risks: cardiopulmonary toxicity (with premature closure of the ductus arteriosus, and pulmonary hypertension, also see Pharmacology: Toxicology: Preclinical safety data under Actions); renal dysfunction, which may progress to renal failure with oligohydramnios.
All prostaglandin synthetase inhibitors may expose the mother and child to the following risks: possible prolongation of bleeding time, an effect of inhibition of platelet aggregation even at very low doses; inhibition of uterine contractions, resulting in delayed or prolonged labour.
Breast-feeding: As with other NSAIDs, small amounts of diclofenac pass into the breast milk. As a precaution, diclofenac should therefore not be used by women who are breast-feeding. If treatment is essential, the infant should be switched to bottle feeding.
Fertility: Diclofenac may impair female fertility and is therefore not recommended in women attempting to conceive. Consideration should be given to stopping diclofenac in women who are having difficulty conceiving, or in those being tested for infertility.
In animals, based on relevant data, impairment of male fertility cannot be ruled out (see Pharmacology: Toxicology: Preclinical safety data under Actions). The relevance of this finding for humans is unclear.