A ground-breaking study from Oxford University has suggested a clear link between the pregnancy test drug Primodos and malformations in babies born to mothers who used the drug.
Sky News can also reveal that a former employee at the drug manufacturers was advised not to use Primodos by a doctor working at the company, while it was still being offered to the general public.
Bayer, which took over the manufacturer Schering, told Sky News: "Bayer is aware of the ongoing Independent Medicines and Medical Devices Safety Review.
“This follows a review by an independent Expert Working Group on Hormone Pregnancy Tests of the Commission on Human Medicines that has already found, consistent with Bayer's view and based on all available data, that the scientific evidence does not support a causal association between the use of hormone pregnancy tests, such as Primodos, and birth defects or miscarriage."
An Medicines and Healthcare Products Regulatory Agency spokesperson responded to the Oxford University study saying: "This publication, which is currently awaiting peer review, does not contain new data.
“It is a different approach to the analysis of existing historic observational data which was reviewed by the Commission on Human Medicines' Expert Working Group on Hormone Pregnancy Tests.”
Sky’s Jason Farrell has this exclusive report to his follow up documentary - Primodos: The Secret Scandal.
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