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Men prescribed sodium valproate are advised to employ contraception while undergoing treatment due to a potential slight increase in the risk of autism and other neurodevelopmental concerns for offspring conceived during this period.
They are urged to continue this practice and refrain from sperm donation until three months post-treatment termination.
Sodium valproate, available under various brand names including Epilim, Belvo, Convulex, and Depakote, is recognized for its efficacy in managing epilepsy and bipolar disorder.
The issuance of this warning by the Medicines and Healthcare products Regulatory Agency (MHRA) emphasizes the importance of consulting with healthcare providers prior to making any adjustments to medication.
‘Safety issue’
This directive follows a comparable caution from the European Medicines Agency, based on data from national registries in Norway, Denmark, and Sweden indicating harm to 5% of children born to men using the drug.
While the study did not conclusively attribute the harm to sodium valproate or compare risks in children whose fathers were not medicated, the MHRA stressed the need for precautionary measures in addressing this critical safety concern.
Though it was previously known to impede fertility, the MHRA indicates that this effect is typically reversible following cessation of the drug.
The support group OACS, dedicated to assisting families impacted by Valproate medications, has censured the MHRA for its delayed scrutiny of safety concerns pertaining to fathers.
Karen Buck, a spokesperson who used the drug during pregnancy for epilepsy, recounts the devastating impact on her daughter Bridget, now 26, afflicted with Fetal Valproate Syndrome requiring round-the-clock care due to severe brain damage.
Karen’s efforts to address this issue as early as 2016 were met with resistance from the regulator, underscoring the need for comprehensive awareness campaigns targeting both men and women.
In January, the MHRA cautioned against the use of sodium valproate in individuals under 55 unless all other treatment options have been exhausted and approved by two independent specialists. However, an estimated 65,000 individuals in this age group continue to utilize the drug.
Dr. Alison Cave, Chief Safety Officer at the MHRA, stresses the importance of not discontinuing medication without medical advice and urges patients to discuss their treatment plan at their next appointment.
Vocabulary List:
- Prescription /prɪˈskrɪp.ʃən/ (noun): A written order from a doctor for a specific medicine.
- Efficacy /ˈɛfɪkəsi/ (noun): The ability to produce a desired or intended result.
- Neurodevelopmental /ˌnjʊə.rəʊ.dɪˈvɛl.əp.mənt.əl/ (adjective): Relating to the development of the nervous system.
- Precautionary /prɪˈkɔː.ʃən.er.i/ (adjective): Taken in advance to protect against possible danger.
- Cessation /səˈseɪ.ʃən/ (noun): The fact or process of ending or being brought to an end.
- Afflicted /əˈflɪk.tɪd/ (adjective): Having or suffering from a disease or injury.
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