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Primodos potentially linked to birth defects

An increase in birth defects led to the drug Primodos being withdrawn in 1977 as doctors were worried there could be a connection.

As a result of a recent safety review, the Government has now issued an apology relating to the use of the drug Primodos.

Between 1958 to 1978, GPs used Primodos as a pregnancy test. It was a hormonal medicine that contained two of the ingredients later used in the “Morning After Pill”. Tablets were taken for 3 days and if a period followed soon after, the pregnancy test was negative. Women were instructed that any existing pregnancy would not be affected.

Primodos was withdrawn in 1977 as doctors were worried by an increase in birth defects seen in babies whose mothers had used the medicine. These included spina bifida, brain and heart problems and deformed limbs.

These claims were disputed for decades. In 2019, a large systematic review concluded that the use of oral hormone pregnancy tests in pregnancy is associated with increased risks of congenital malformations.

In July 2020, the Independent Medicines and Medical Devices Safety Review, led by Baroness Cumberlege, published a report saying: “In our view Primodos continued to be given as a pregnancy test for years longer than it should. In the face of growing concerns it should have ceased to be available from 1967. A non-invasive alternative was available by then, and the concerns that were being expressed should have led to action by the regulator. It continued to be given to women for years longer.

“While there is disagreement between experts about whether Primodos caused birth defects, the fact remains that thousands of women and unborn children were exposed to a risk that was acknowledged at the time. That should not have happened. This is not a case of us judging the actions of the past by the standards of today. This was discussed at the time, but not acted upon. The system failed.”

The Health Secretary Matt Hancock in an interview with Sky News, stated:  “I want to issue on behalf of the NHS and the whole healthcare system a full apology to those who’ve suffered and their families, for their frustration, for the time it’s taken to get their voices heard.”

If your mother was prescribed a Primodos test and you were born in the late 1950s up until 1978, it is possible that you have been affected. You may be able to seek compensation. As experts in medical negligence, we are able to offer advice. If you would like further information call 01302 320621 or email info@athertongodfrey.co.uk

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