Sodium Valproate & Birth Defects

Research suggests that sodium valproate may interfere with the development of a baby before birth. Mothers that took the drug while pregnant have a 10% risk of developing congenital disabilities. Up to 40% may have learning problems as they grow. According to the Medicines and Healthcare Products Regulatory Agency (MHRA), it should not be prescribed to pregnant women or those who intend to get pregnant in the near future. It is unsafe unless one is on a pregnancy prevention program.

Valproate – Use in Ireland

A valproate brand is licensed in Ireland. However, it may exist in different brand names in other countries. The European Medicines Agency recommended restrictions on the use of the drug in February 2018.

It can no longer be used on women or girls who have the potential to bear children unless they meet the terms of the Valproate Pregnancy Prevention Program. The program covers measures to make sure that women taking the drug are aware of the risks it presents and realise the need to avoid getting pregnant while on it.

The program states that a branded Valproate should not be used in female children or women with the potential to have children unless all other treatment options fail. The manufacturer has come up with educational material to ensure that patients understand the risks of the drug.

European Medicine Agencies

In March 2018, the CMDh endorsed a few guidelines that can help protect babies from exposure to valproate medicines. The CMDh is a regulatory body that represents members of the EU, Norway, Iceland, and Liechtenstein.

Even though the EU has approved the use of the drug in treating bipolar disorder and epilepsy, new measures have banned its use during pregnancy and for girls who can have children. According to the program, patients have to get a visual and text warning on the medicines packaging. The patient cards must also include warnings.

Companies that market branded Sodium Valproate are required to carry out more studies regarding the nature of the drug, the risks, it presents, and the extent of risks on different women. They have to monitor its use and long-term effects on expectant mothers. The position of CMDh was presented to the EU, which issued a legally binding decision that applies across the European Union.

What Is the Drug Sodium Valporate Used for?

The primary purpose of the drug is to treat epilepsy in both children and adults. It belongs to a group of drugs known as anticonvulsants. It controls brain chemicals that send signals to nerves to prevent seizures. It is also great for dealing with mania. Doctors may prescribe it alone or in combination with other medications. You may only get the medicine upon prescription.

What are the side effects of Sodium Valporate?

The drug has a few side effects. They may range from mild to severe, and you won’t necessarily experience all of them. They include the following:

  • Appetite changes
  • Diarrhoea
  • Enlarged or bleeding gums
  • Depression
  • Nausea/vomiting
  • Confusion or hallucinations
  • Uncontrolled eye movements
  • Increased agitation or aggression
  • Hair loss

DISCLAIMER

Please be advised that the above-mentioned material is intended as an overview and as a broad out-line of the topic discussed. It should not be considered as complete and comprehensive legal advice, nor act as an appropriate substitute.
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