A drug that has caused physical deformities and neurological problems in tens of thousands of babies is still prescribed to pregnant women.
The drug for epilepsy sodium valproate has been given to women in the United Kingdom for years without proper warnings, according to The Sunday Times.
Jeremy Hunt, a former health minister, called for an “immediate solution” to prevent the “harm” reportedly caused by the drug.
According to a review published in 2020, 20,000 Britons were affected after being exposed to the drug as developing babies.
At the time, the review said that “hundreds” of babies were still born each year to foster mothers who were unaware of the risks.
According to the latest data, 222 pregnant women were exposed to sodium valproate in the period 2020-2021, according to the Agency for Regulation of Medicines and Health Products (MHRA).
They said exposure levels have been declining since the introduction of the Pregnancy Prevention Program, and levels in 2020-2021 are “significantly lower”.
Mr Hunt said sodium valproate was a “high risk to patient safety” as he called for a ban on it being given to pregnant women.
A spokesman for NHS England said it had set up an expert group to help reduce valproate use by 50% next year by women who could become pregnant.
Janet Stockley-Pollard, one of the mothers who claims that the drug sodium valproate, also known as Epilim, caused a number of birth defects at a press conference in London in 2011.
(PA)
Mr Hunt told the Sunday Times: “It is time for the British state to face its responsibilities. Just like we ended up with the victims of the thalidomide scandal.
“It is unbelievable that after so many warnings, this is still not in order. This is a serious risk to patient safety and ministers must order immediate adjustments to prevent more avoidable damage. “
He said it was time for the National Health Service “to stop procrastinating on this issue”, saying that “it cannot be right to risk disability for so many babies when the effects of the drug are so well known”. .
Dr Alison Cave, MHRA’s chief safety officer, said that the use of valproate during pregnancy carries “significant risks of harm to the baby” and should not be taken by anyone with childbearing potential unless there is a program. for the prevention of pregnancy, which includes the use of effective contraception ”.
Every year, every woman on the drug must sign an annual risk confirmation form with her healthcare professional, as circumstances regarding the risk of pregnancy may change, Dr. Cave added.
She said work was continuing on the use of the drug in humans, “where there are no other options available.”
She added: “Our work on the safety of sodium valproate continues and we will continue to review, adapt and implement regulatory measures, where appropriate, that will allow the continued safe use of this drug in persons who may become pregnant when there are no other viable opportunities ”
Mr Hunt launched a review in 2018 on how the health service has responded to concerns about sodium valproate.
This review also looks at the pelvic network – which is linked to crippling, life-changing complications, including chronic pain, infections and loss of sex life – and hormonal pregnancy tests such as Primodos, which are thought to be linked to birth defects and spontaneous abortion.
Back row, left to right: Susan Cole, Janet Williams, Samantha Scott. First row, left to right: Janet Stockley-Pollard and Emma Friedman, all mothers who claim that sodium valproate has caused a number of birth defects
(PA)
The review, chaired by Baroness Cumberlege, made a series of recommendations.
These include the appointment of an independent Commissioner for Patient Safety who is outside the health system; calls on the government to issue an “full apology” immediately on behalf of the health system of the families concerned; reform of the regulatory body for medicines and medical devices; and a register of all “financial and non-property interests of all doctors”.
The Sunday Times reported a package of the drug without a leaflet with patient safety information inside.
The MHRA said it would investigate all cases where important safety information on pregnancy risks was not provided.
Responding to a Sunday Times story, a spokesman for the Ministry of Health (DH) said: “Patient safety is a priority and we take all reports and inquiries on this issue very seriously.
“As stated in our reply, we have accepted most of the recommendations in Baroness Cumberlege’s report. We want to improve the future safety of medicines and medical devices – by ensuring that they are used in accordance with the latest evidence of best practice – and there are wider forms of compensation for those who need it.
An NHS England spokesman said: “The NHS has set up an expert group to help reduce the use of valproate by women who could become 50% pregnant next year.
“Last year, the NHS wrote to all women and girls aged 12-55 in England about the drug to remind them of the risks of the drug during pregnancy and to work with partners on a number of initiatives to reduce the risk of valproate.
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