Dáil debates

Thursday, 19 April 2018

Other Questions

Medicinal Products Regulation

11:30 am

Photo of Bobby AylwardBobby Aylward (Carlow-Kilkenny, Fianna Fail) | Oireachtas source

In a reply to a parliamentary question from my colleague, Deputy Lisa Chambers, in November last year the Minister acknowledged that children exposed to valproate in the womb had an increased risk of congenital malformations and neural development disorders, including autism. He also stated that a warning label for the outer packaging of the Epilim product was introduced in Ireland in early 2017 and that products carrying the new external warning label were being supplied to retail pharmacies. I have different information. I met two mothers from Kilkenny who got a packet of the product in a local chemist in Kilkenny in November and there were no warning signs on it. It is not being implemented. Are the Department and the HSE enforcing this directive well enough?

Is the Minister monitoring the implementation of this warning label on these products, which he previously acknowledged pose an increased risk to pregnant women? I ask this because I met two women who have been affected by this and both of them were still receiving the drug Epilim in a plastic bag with no warning label. They were understandably and genuinely upset, not only because of their own personal situation but because they were all too familiar with the increased risk and danger being posed to other women by the lack of such warning labels. Is the Department and the HSE doing enough in raising awareness and warning vulnerable women of the risks posed by medicines that contain sodium valproate?

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