Primodos

Department of Health written question – answered on 6th April 2017.

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Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

To ask Her Majesty’s Government, further to the Written Answer by Lord O’Shaughnessy on 28 March (HL6261), whether the Expert Working Group on Hormonal Pregnancy Tests will review the reasons why tests on Primodos, which remained on the market until 1978 despite the publication of a study in 1967 indicating a causal relationship between hormonal pregnancy tests and congenital abnormalities, were not ordered by the Committee for the Safety of Medicines under the Medicines Act 1971.

Photo of Lord O'Shaughnessy Lord O'Shaughnessy The Parliamentary Under-Secretary of State for Health, Lord in Waiting (HM Household) (Whip)

The terms of reference of the Expert Working Group on Hormonal Pregnancy Tests are focused on a scientific review of the strength of evidence for a possible association between exposure in pregnancy to hormonal pregnancy tests and adverse outcomes in pregnancy. An important part of the Group’s work is to consider what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy.

Records show that the Committee on Safety of Drugs (subsequently the Committee on Safety of Medicines) carefully considered the results of the 1967 study and considered the methodology to be flawed.

In 1969, the Committee on Safety of Drugs requested the manufacturers of hormonal pregnancy tests to provide all relevant laboratory data and initiated their own long-term study of maternal drug histories in mothers of children with birth defects. In 1970, the Standing Committee on the Classification of Proprietary Medicines (the ‘MacGregor Committee’) asked Schering, the then licence holder, to remove ‘diagnosis of pregnancy’ from the indications for Primodos.

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