- Medicines and Healthcare products Regulatory Agency
- Part of:
- Patient safety
- 25 March 2015
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We are asking the public for evidence about the use of hormonal pregnancy tests and possible adverse effects in pregnancy including birth defects.
This consultation ran from
Following concerns felt by those who believe they or their children have been affected by the use of hormonal pregnancy tests (HPTs), the government committed to carrying out a review of HPTs and possible adverse effects in pregnancy including birth defects. All evidence submitted will be reviewed by independent experts in relevant scientific disciplines. The review is expected to be completed by the beginning of 2016.
As part of this process, we are asking for individuals, organisations and companies to send us information that they feel is relevant to be considered by the experts. 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.
All information should be sent to the MHRA by 30 June 2015. To respond to the call for evidence you can use the email address or postal address below.
You can report suspected adverse effects relating to HPTs through a Yellow Card report.
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 and in 1975 the Committee on Safety of Medicines recommended that doctors should not use HPTs. These products were withdrawn from the market in the late 1970s.
Hormonal pregnancy tests (including Primodos) and possible association with birth defects: call for evidence
PDF, 94.1KB, 7 pages
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Published: 25 March 2015