The review will look into how safety and side-effects concerns from people are handled by the NHS and medicine regulators. They will focus around the way three scandals were handled. One of these is around the safety concerns regarding sodium valproate.
Sodium valproate is used to treat epilepsy in some people. In some women, sodium valproate is a very effective epilepsy medicine, and may be the only one that works.
However, it has been associated with an increased risk of developmental problems and birth defects in babies if taken during pregnancy.
Reports have said that the risks have been known since the 1970s. But this information was not made widely available until many years later. This has affected many families and has been called a “scandal” in parliament.
The review will be led by Baroness Julia Cumberlege. As part of this, two other treatment “scandals” will be looked into. One is the pregnancy test drug Primodos, which it is claimed has led to birth defects and miscarriages in women. The other is the vaginal mesh implant, which has been linked to severe and “life-changing” side-effects for women.
Prime Minister Theresa May said during Prime Minister’s Questions that these issues have shown a problem with the regulatory and healthcare system.
Health and Social Care Secretary Jeremy Hunt has said that “the response to these issues from those in positions of authority has not always been good enough”.
The Health Secretary said the review will also look into the NHS and regulatory body processes taken after concerns are reported.
Epilepsy Action deputy chief executive Simon Wigglesworth said: “Today’s announcement marks a major breakthrough for the thousands of women with epilepsy who’ve campaigned for change around sodium valproate.
“We urge Baroness Cumberlege to fully consider the decades of evidence provided by campaigning groups, including Epilepsy Action. This will help those families who’ve suffered can get some closure. It will also help women with epilepsy make fully-informed decisions about their treatment and planning a family.
“We welcome Jeremy Hunt’s commitment to implementing the European Medicines Agency’s recommendations around sodium valproate. For many women with epilepsy, sodium valproate is the only drug that works. However, we know for most others, there are equally effective epilepsy medicines which are safe to use in pregnancy.
“We also recommend that sodium valproate should not be prescribed as a first treatment option without a full discussion with a specialist.
“It remains to be seen how and when these recommendations will be implemented and we are working with UK decision-makers to see how they will work in practice. Until things change, women and children will continue to be affected by something that can be potentially prevented.”
Epilepsy Action advises that women taking this medicine continue to do so as prescribed, unless advised otherwise by their doctor. Women should speak to their doctor if they have concerns about their medicine. Stopping epilepsy medicine could result in breakthrough or worsened seizures, which could harm the mother and baby.
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