Claim 849cb6e2Checked 21 Jul 2026
TrueOn the truth scale
Patients were not informed about those risks.
Sarah GreenLiberal DemocratLD / Chesham and Amersham·Engagements·03 Jun 2026Factual · historical current chronological
Reasoning & Evidence21 Jul 2026
The claim that patients were not informed about the risks of taking sodium valproate during pregnancy is strongly supported by multiple official and reputable sources: **The Cumberlege Report ("First Do No Harm", July 2020)** — the official Independent Medicines and Medical Devices Safety Review — explicitly documented this failure. The report stated: "We heard from women who were never told of the effect their [epilepsy medication] could have on their unborn children or, if they had been alerted to the risk, they were reassured that those risks were low and could be scanned for and fixed." The report dedicated an entire theme to this: "Theme 3: 'I was never told' – the failure of informed consent." It further noted that the system did not know "how many women over four decades took sodium valproate… who then went on to become pregnant because they had not been properly informed as to the risk they were taking." **The Guardian (February 2024)** reported that papers from the early 1970s revealed the Committee on Safety of Medicines (CSM) concluded the risk was low and "that patients should not be informed, in order to avoid 'fruitless anxiety'" — a deliberate decision to withhold information. **Evidence submitted to the IMMDS Review** by patient groups documented that no direct-to-patient information about teratogenic risks appeared in Patient Information Leaflets until 1997, and that until 2003 PILs were "positively misleading." A 2017 survey found that 28% of women taking sodium valproate said they had not been informed of the risks in pregnancy. **BBC News** reported that "Many parents have claimed they were not made aware of the risks from taking the treatment while pregnant, even after new safety warnings were introduced in 2016." The claim accurately reflects a well-documented systemic failure over decades, confirmed by official government-commissioned reviews. While not every single patient may have been uninformed (some may have been told by individual clinicians), the core assertion — that patients were systemically not informed about the risks — is accurate and well-established. Sources: The Independent Medicines and Medical Devices Safety Review ("First Do No Harm"), https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf ; IMMDS Review evidence from patient groups on sodium valproate, https://www.immdsreview.org.uk/downloads/Evidence/FOR%20PUBLICATION%20-%20Patient%20Groups%20-%20Sodium%20Valproate.pdf ; The Guardian, "The mothers fighting a scandal bigger than thalidomide" (Feb 2024), https://www.theguardian.com/society/2024/feb/22/the-mothers-fighting-a-scandal-bigger-than-thalidomide-we-were-told-the-medication-was-safe ; BBC News, "Mums demand answers over sodium valproate drug that harmed babies," https://www.bbc.co.uk/news/articles/c3v3rwg2490o ; BBC News, "Disabilities caused in babies by epilepsy drug a 'scandal'," https://www.bbc.co.uk/news/uk-england-london-42717083
From speech
Q8. Yesterday, at an event here in Parliament, I spoke to women whose children suffered avoidable harm after they continued taking the epilepsy drug sodium valproate during pregnancy. Doctors knew the risks and patients were not informed, and that has had devastating consequences. I am sure that the Prime Minister would agree that the fact that a Government Department commissioned a report looking at how to provide a redress scheme raised an expectation that one was on the horizon. To then not introduce such a scheme would be unbelievably cruel. When will this Government respond to the Hughes report and finally establish a redress scheme for the families?
Sources opened
[1]bbc.co.uk
https://www.bbc.co.uk/news/articles/c3v3rwg2490o
[2]immdsreview.org.uk
https://www.immdsreview.org.uk/downloads/Evidence/FOR%20PUBLICATION%20-%20Patient%20Groups%20-%20Sodium%20Valproate.pdf
[3]theguardian.com
https://www.theguardian.com/society/2024/feb/22/the-mothers-fighting-a-scandal-bigger-than-thalidomide-we-were-told-the-medication-was-safe
[4]bbc.co.uk
https://www.bbc.co.uk/programmes/m001nvs4
[5]bbc.co.uk
https://www.bbc.co.uk/news/uk-england-london-42717083
[6]patientsafetycommissioner.org.uk
https://www.patientsafetycommissioner.org.uk/wp-content/uploads/2024/02/Redress-Report_.pdf
[7]patientsafetycommissioner.org.uk
https://www.patientsafetycommissioner.org.uk/our-work/redress/
[8]patientsafetycommissioner.org.uk
https://www.patientsafetycommissioner.org.uk/wp-content/uploads/2024/02/14.385_DHSC_OPSSC-Redress-Report.pdf
[9]commonslibrary.parliament.uk
https://commonslibrary.parliament.uk/research-briefings/cbp-10487/
[10]pharmaceutical-journal.com
https://pharmaceutical-journal.com/article/news/patient-safety-commissioner-to-approach-pm-over-disappointing-delay-to-valproate-compensation
[11]immdsreview.org.uk
https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
[12]immdsreview.org.uk
https://www.immdsreview.org.uk/Report.html
[13]epilepsy.ie
https://www.epilepsy.ie/sites/www.epilepsy.ie/files/IMMDS%20INQUIRY%20REPORT.pdf
[14]bjgp.org
https://bjgp.org/content/70/699/477
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