Follow guidelines to avoid valproate complaints and claims

Warnings to doctors over the harmful effects of the valproate medications – which, if taken by girls or women of child-bearing potential, can cause birth defects and developmental disorders in children – have been circulating for years.

As a result, many health organisations have introduced guidelines to advocate appropriate prescribing of valproate.

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It is advised that valproate should not be used in girls or women of child-bearing potential, unless appropriate contraception or pregnancy prevention is in place, and patients should be made aware of the significant risks. Evidence is also emerging that there may be a small increased risk of children fathered by men taking valproate being diagnosed with neurodevelopmental disorders. Nevertheless, its use during pregnancy has not been eliminated. In England, between April 2018 and September 2021, 247 pregnant patients received the drug.¹

Inevitably, medicolegal consequences have begun to emerge.

Earlier this year, manufacturer Sanofi was ordered to pay over a quarter of a million euros to a mother in France whose two children were born with disabilities attributed to prenatal exposure to sodium valproate.²

While most legal action is being directed towards manufacturers and healthcare providers, some individual doctors are also being targeted. Medical Protection is currently supporting a number of members who are facing claims.

According to Medical Protection’s Deputy Medical Director Dr Sarah Townley, the best protection against a claim is to make sure you are fully aware of the current guidance on use of sodium valproate.

“Any future claim may consider the guidelines that were in operation at the time of treatment, so being aware of and referencing those guidelines within your clinical care will not only offer the optimal care for your patients, but also decrease your chances of receiving a complaint or claim.”

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And for those members who do find themselves facing litigation, Medical Protection has the experience and legal expertise to help

To get medicolegal advice or request our assistance, call 0800 561 9090 Our lines are open 24/7 in an emergency.

References

1. Mahase E. Sodium valproate continues to be prescribed in hundreds of pregnancies, data show. BMJ. 2022 Apr 21;377:o1013.
2. Casassus B. Valproate: Sanofi ordered to pay €285 000 to mother whose children had birth defects. BMJ. 2024 Sep 17;386:q2034.