The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a public call for evidence relating to the use of oral hormonal pregnancy tests (HPTs, which are no longer prescribed in the UK) and adverse effects relating to pregnancy including possible birth defects.
HPTs such as Primodos were available in the 1960s and 1970s and were widely used to diagnose pregnancy. In 1967, a study raised initial concern that use of HPTs may be associated with birth defects. The then Committee on Safety of Medicines (CSM) kept this issue under review and in 1975 recommended that in view of the possible concern, and the availability of alternative methods, doctors should not use HPTs. These products were withdrawn from the market in the late 1970s.
In October 2014, the government committed to an independent review of the evidence relating to HPTs and the possible risk of birth defects. The review is not a political inquiry intended to demonstrate liability, but to examine the evidence to assess whether there are grounds for accepting a link between the use of HPTs and the conditions experienced by some patients.
A group of experts in relevant scientific disciplines is currently being convened to conduct the review, which is expected to be completed by the beginning of 2016.
To ensure all the available evidence is reviewed, the MHRA is currently in the process of obtaining all relevant documents. As part of this process, the MHRA is asking any individual or organisation with information they feel is relevant to submit it for consideration by the experts during the review. All evidence submitted will be included in the review and a report (including a public summary) will be made publicly available once the review is complete.
Dr June Raine, the MHRA’s Director of Vigilance and Risk Management of Medicines, said:
“We encourage people to send us any information they consider is relevant to previously used hormonal pregnancy tests and potential adverse effects that they think may have been associated with these drugs.
“It is important that we hear from people who feel they or their child have been affected adversely by hormonal pregnancy tests. We encourage anyone who wants to provide information about a suspected adverse effect from use of a HPT to submit it to us via a Yellow Card report.
“We would also welcome any other published or unpublished evidence you consider relevant and wish to submit for the review and ask that you send this to us by the end of June 2015.
Information on how to submit information to the review.
The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are as safe as is reasonably possible. Underpinning all our work lies strong and evidence-based judgements to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health.
All evidence reviewed will be made publicly available (subject to considerations of the Freedom of Information Act and Data Protection Act).