Why does the BNF recommend an interval of 3 months between the end of treatment with methotrexate and conception?
The BNF advises avoidance of conception for 3 months following treatment with methotrexate. The advice takes account of the summaries of product characteristics (SPCs) for Maxtrex® tablets 10 mg (date of last revision March 2003), Wyeth’s Methotrexate injection 25mg/mL (date of last revision May 2000), and Wyeth’s Methotrexate tablets 10 mg (date of last revision May 2000). The SPCs for the two strengths of Maxtrex® tablets differ in their recommendations; Maxtrex® 2.5mg SPC1 recommends avoidance of pregnancy for 6 months whereas Maxtrex® 10 mg SPC2 recommends avoidance of pregnancy for 3 months after discontinuation of methotrexate. The manufacturers as well as the Medicines and Healthcare products Regulatory Agency are aware of this discrepancy. The BNF understands that it is intended to standardise the advice to show that pregnancy should be avoided for 3 months after treatment with methotrexate.
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