The government has said it will “reconsider” its stance on the epilepsy drug sodium valproate, after an investigation by the Sunday Times revealed it is still being given to pregnant women despite the known risks.
The drug is an effective anti-epileptic, however, it is known to cause neurological issues and physical disabilities in developing babies when given to pregnant women.
The risks associated with sodium valproate have been known since the 1970s, but this information wasn’t made widely available until years later.
In 2020, a review led by by Baroness Julia Cumberlege revealed that an estimated 20,000 babies in the UK had been affected by exposure to sodium valproate.
Of these unborn children, the review states one in 10 “are likely to suffer physical birth defects such as spina bifida, hare lip and cleft palate, heart problems and limb defects, and 40% will have a developmental delay or autism.”
Following the publication of the report, the Medicines and Healthcare products Regulatory Agency (MHRA) said that the drug must not be prescribed to those who could become pregnant unless they are strictly taking birth control.
At the time of the report’s publication, Epilepsy Action’s deputy chief executive, Simon Wigglesworth, said: “Nothing can undo the avoidable harm and distress that has been caused by the decades of government silence and inaction. However, with the publication of the report and these recommendations, we can now start to move forward.”
In spite of these findings, the MHRA says that sodium valproate is still being given to pregnant mothers, and between April 2018 and September 2021, 247 women were prescribed the drug in a month in which they were pregnant.
When investigated further, the Sunday Times found the drug is being handed out to women “in plain packets with information leaflets missing, or with stickers over the warning.”
The former health secretary Jeremy Hunt says doctors should now be banned from prescribing the drug to pregnant women, and that families affected should be properly compensated.
In a tweet, he said that Ministers must now order an “immediate fix” to prevent any more avoidable harm, and today in parliament, he asked the Health Secretary Sajid Javid if it was time for the government to reconsider its stance on the drug.
In response, Javid said “it is right” that the government “reconsiders” prescribing the drug to pregnant women. He added: “We [must] make sure that, whether its sodium valproate or any other medicines, that they are only given in the clinically appropriate settings”.
