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Call For Evidence On Previously Licensed Oral Hormonal Pregnancy Tests

MHRA Decision Backed By Specialist Lawyers


Specialist Product Liability lawyers at Irwin Mitchell have welcomed today’s move by the Medicines and Healthcare products Regulatory Agency (MHRA) to launch a public call for evidence relating to the use of oral hormonal pregnancy tests and associated adverse effects relating to pregnancy.

Hormonal pregnancy tests (HPTs) were widely used in the UK between 1953 and 1978 to diagnose pregnancy. Patients who took the HPT were given two tablets, the first dose of which contained a large dose of progesterone. It was thought that if the woman was pregnant this large dose of progesterone would be simply absorbed into the body and if the patient wasn’t pregnant it would trigger menstruation. 

The first suggestion of a link between HPTs and congenital malformations was published in 1967. In 1975 the Committee on Safety of Medicines (now the MHRA) issued a warning that HPTs should not be given to pregnant women. HPTs were later removed from the UK market in 1978.

Today’s call from the MHRA follows the Government’s promise in October 2014 to complete an independent review of the evidence relating to HPTs and the possible risk of birth defects

The MHRA are currently convening a ground of medical experts who hope to complete their review of HPTs by early 2016. To assist the review the MHRA have asked that any individual or organisation with information related to HPTs, including individuals who believe they or their children have been injured as a result of HPTs, to send this information to the MHRA by June 2015.
David Body, a partner of Irwin Mitchell’s product liability team who has represented previous large group actions in medical negligence and product liability cases, welcomes today’s announcement from the MHRA.

If you or a loved one has been injured or fallen ill due to a faulty medical device or medicine, our medical negligence claims team could help you claim compensation. View our Defective Medical Device & Medicines Claims page for more information.

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