AI Article Synopsis
- The European Medicines Agency (EMA) is recommending precautionary measures due to concerns about neurodevelopmental disorders in children of men treated with valproate.
- The UK's Medicines and Healthcare products Regulatory Agency (MHRA) went further, advising against prescribing valproate to anyone under 55.
- Members of ENTIS and OTIS argue that these warnings are premature and that the scientific evidence does not strongly support the risk of paternal transmission of issues from valproate.
Article Abstract
On January 12, 2024 the safety committee of the European Medicines Agency (EMA) recommended precautionary measures over a potential risk of neurodevelopmental disorders in children born to men treated with valproate. These new measures recommend patient supervision by a specialist in the management of epilepsy, bipolar disorder, or migraine. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a far more stringent precaution, warning against prescribing valproate to anyone under 55 years of age. We, members of the European Network of Teratology Information Services (ENTIS) and the Organization of Teratology Information Specialists (OTIS), believe that the EMA and MHRA warnings were premature. We are of the opinion that the underlying scientific data do not convincingly substantiate the inference of a paternally mediated risk from valproate to children, much less to an extent that justifies these far-reaching recommendations.
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| http://dx.doi.org/10.1002/bdr2.2392 | DOI Listing |
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