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    Friday, 27 April 2018 12:12
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A pregnant lady imageApril 27 2018

Women and girls of childbearing potential must no longer take valproate medicines unless the conditions of the Pregnancy Prevention Programme are being met.

In addition, “use of valproate in pregnancy is contraindicated for bipolar disorder and must only be considered for epilepsy if there is no suitable alternative treatment.”

The medicines regulator the MHRA is calling on health professionals to ensure that “all women and girls (and their parent, caregiver, or responsible person, if necessary) are fully informed of the risks and the need to avoid exposure to valproate medicines in pregnancy.”

In a Drug Safety Update published on April 24, the MHRA says that valproate should only be considered in such circumstances if other treatments are ineffective or not tolerated, as judged by an experienced specialist.

GPs are being asked to contact all female patients who may be of childbearing potential to 

  • provide the Patient Guide;
  • check they have been reviewed by a specialist in the last year; and
  • check they are on highly effective contraception.

In addition to male and/or female sterilisation, methods of contraception considered “highly effective” are long-acting reversible contraceptives (LARC) with a less than 1% failure rate: 

  • copper intrauterine device (Cu-IUD);
  • levonorgestrel intrauterine system (LNG-IUS);
  • progestogen-only implant (IMP).

“If a user-independent form is not used, two complementary forms of contraception including a barrier method should be used and regular pregnancy testing considered,” says the MHRA.

It will be sending information to health professionals regarding the Valproate Pregnancy Prevention Programme and has updated online materials to reflect the updated status around valproates. 

Computer systems suppliers have updated pharmacy IT systems to include an alert when valproates are dispensed, and GP systems are being upgraded with a search and audit function to allow GPs to identify women on valproates.

Simon Wigglesworth, deputy chief executive of the charity Epilepsy Action, said: “We welcome the revised measures which reflect the seriousness of the risks to the unborn children of women with epilepsy during pregnancy. It is vitally important that healthcare professionals ensure that all women with epilepsy taking sodium valproate are reviewed in line with the new guidelines.”

Link:
MHRA DSU on valproate           
Epilepsy Action statement        

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