Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Fertility
Animal research has shown that administration of colchicine may negatively influence spermatogenesis (see section 5.3). Rare cases of reversible oligospermia and azoospermia in men are known from literature.

In case Colchicine is used for treatment of FMF

Since the course of FMF without treatment may also lead to infertility, the use of colchicine should be weighed against the potential risks and may be considered, if clinically needed.

In case colchicine is used for treatment of acute gout or for prophylaxis of agout attack during initiation of urate-lowering therapy
Male patients should not father a child during and for at least 6 months following termination of colchicine therapy (see section 4.4). If, nevertheless,pregnancy occurs during this time period, genetic counselling should be tasked.

Pregnancy
Animal studies denote reproductive toxicity (see section 5.3).

In case colchicine is used for treatment of FMF
A moderate amount of data on pregnant women with FMF indicate no malformative or feto/ neonatal toxicity of colchicine. Since the course of FMF without treatment may also negatively influence pregnancy, the use of colchicine during pregnancy should be weighed against the potential risks andmay be considered, if clinically needed.

In case colchicine is used for treatment of acute gout or for prophylaxis of agout attack during initiation of urate-lowering therapy
There is a limited amount of data from the use of colchicine in pregnant women with gout. As a precautionary measure, use of colchicine in this patient population and in women of childbearing potential not using effective contraception, should be avoided and may only be considered if other treatment options, including NSAIDs and glucocorticoids, are not applicable. Female patients have to use effective contraception during and for at least three months following termination of colchicine therapy (see section 4.4). If, nevertheless, pregnancy occurs during this time period, genetic counselling should be tasked.

Breast-feeding
Colchicine/metabolites is /are found in breastfed newborns/infants of treated women.
There is insufficient information on the effects of colchicine in newborns/infants.
Colchicine should not be used in breast-feeding women with gout. In lactating mothers with FMF, a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Colchicine therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.