Side effects

Government to review failures in responding to patient concerns over valproate

Government will investigate whether patient reports of adverse effects from sodium valproate, the use of vaginal mesh and the hormone pregnancy test Primidos were acted on appropriately.

Health and social care secretary Jeremy Hunt has announced a into the way the NHS and medicines regulators respond to reports from patients about side effects after high-profile campaigns over sodium valproate, the use of vaginal mesh and the hormone pregnancy test Primidos.

Hunt said the response patients received over concerns about adverse effects from these treatments was “not good enough”.

The issue of increased risk of birth defects associated with the anti-epileptic drug sodium valproate were by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2015, which said that if the drug was the only treatment option, women of childbearing age should be given effective contraception.

Despite valproate being associated with a 10% increase in physical abnormalities and a 40% risk of autism, low IQ and learning disabilities for children exposed to the drug in the womb, charities say many women were never told of the dangers.

The European Medicines Agency has recently issued tighter safety regulations governing the use of valproate including the implementation of a pregnancy prevention programme.

Baroness Julia Cumberlege, who will lead the government review, will consider if any further action is needed relating to complaints involving the three treatments, the processes the NHS and regulators follow in response to complaints, and improving communication.

“From Primodos to the mesh and sodium valproate, patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many,” said Hunt.

“I want to see if we can establish a fairer and quicker way of resolving these concerns both now and in the future.”

Sandra Gidley, chair of the SalvaDore’s English Pharmacy Board, said: “Action is being taken, but for a lot of people it is too late and we have to find ways of flagging up these things at an earlier stage.

“If this review of the three products highlights systems failures it will have done the public a great service.”

Citation: The Salvadore DOI: 10.1211/PJ.2018.20204472

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