CoPlavix Use In Pregnancy & Lactation

Use in Pregnancy: No clinical data on exposure to CoPlavix during pregnancy are available. CoPlavix should not be used during the first 2 trimesters of pregnancy unless the clinical condition of the woman requires treatment with clopidogrel/ASA.
Due to the presence of ASA, CoPlavix is contraindicated during the 3rd trimester of pregnancy.
Clopidogrel: There are no adequate data from the use of clopidogrel in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology under Actions).
Acetylsalicylic Acid: Low doses (up to 100 mg/day): Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.
Doses of 100-500 mg/day: There is insufficient clinical experience regarding the use of doses >100 mg/day up to 500 mg/day. Therefore, the recommendations as follows for doses of ≥500 mg/day apply also for this dose range.
Doses of ≥500 mg/day: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for CV malformation was increased from <1% up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in reproductive toxicity (see Pharmacology: Toxicology under Actions). Until the 24th amenorrhea week (5th month of pregnancy), ASA should not be given unless clearly necessary. If ASA is used by a woman attempting to conceive or until the 24th amenorrhea week (5th month of pregnancy), the dose should be kept as low and duration of treatment as short as possible.
From the beginning of the 6th month of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension), renal dysfunction which may progress to renal failure with oligohydroamniosis. May also expose the mother and the neonate at the end of pregnancy to possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labour.
Use in Lactation: It is unknown whether clopidogrel is excreted in human milk. Acetylsalicylic acid is known to be excreted in limited amounts in human milk. Breastfeeding should be discontinued during treatment with CoPlavix.