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Mycophenolate and Pregnancy New Warning

Spring 2016 Contraceptive Advice

Mycophenolate and pregnancy: new warning 

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its safety advice on the importance of contraception for both women and men who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA).

 MMF and MPA are associated with a high risk of serious birth defects and an increased risk of miscarriage. So the MHRA advises that:

  • MMF or MPA should not be used in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
  • MMF and MPA treatment should only be started in women of childbearing potential after a negative pregnancy test result to rule out unintended use in pregnancy.
  • MMF and MPA should only be given to women of childbearing potential who are using highly effective contraception: i.e. two forms of effective contraception during treatment and for six weeks after stopping treatment.
  • Men (including those who have had a vasectomy) should use condoms during treatment and for at least 90 days after stopping treatment.
  • Female partners of male patients treated with MMF or MPA should also use highly effective contraception during treatment and for 90 days after the last dose.
  • If pregnancy occurs, patients should not stop treatment but should consult their doctor immediately.

This updated advice has been issued after a review of studies of Cellcept, the original brand of MMF. According to the MHRA, product information for other versions of MMF and for mycophenolate sodium (Myfortic) will be updated accordingly in due course. MPA is the active metabolite of MMF: i.e. the active form of the drug after it has been processed by the body.

To find out more, read the Drug Safety Update advice at www.gov.uk/drug-safety-update