The Epilepsy Society in the U.K. reported that the Academic of Medical Royal Colleges (AMRC) is advising doctors not to prescribe sodium valproate to women with epilepsy who are of childbearing age or pregnant, unless other treatments are ineffective or not tolerated.
Even then, the AMRC said, sodium valproate treatment must be started and supervised by a doctor experienced in managing epilepsy, and women using the drug must be informed of its risks and benefits to them and to an unborn child.
Similar warnings have been issued by the U.S. Food and Drug Administration.
According to the AMRC, sodium valproate, an anti-convulsive drug (brand names include Depacon in the U.S., and Epilim, Episenta or Epival in the U.K.), is one of 40 common medications used for a range of disorders, including epilepsy, migraine, and bipolar disorder, that should not be routinely prescribed.
Evidence from studies has shown that 10 percent babies born to women who take the sodium valproate during their pregnancy are at risk of a congenital malformations, and between 30 percent and 40 percent of these infants are at high risk of developmental disorders.
According to Ley Sander, professor neurology at UCL Institute of Neurology in London and medical director at the Epilepsy Society, the new AMRC recommendation is in line with the guidelines for sodium valproate from the U.K.’s Medical and Healthcare products Regulatory Agency. That agency also warns that children exposed to sodium valproate in utero are at risk of developmental disorders and congenital malformations, and that women must be informed to the drug’s potential risks.
“For some women sodium valproate may be the only drug that will control their seizures and this is one of the biggest challenges for both doctors and patients. Seizures are not benign events,” Sander said in a news release. But, he added, “In some circumstances tonic clonic seizures can cause miscarriage, traumas related to falls or blood conditions that may harm the developing baby.
“It is very important to discuss the risks of sodium valproate against the risks of seizures for both mother and the developing child. Sodium valproate should only be prescribed if no other epilepsy drug will work.”
The AMRC recorded 40 treatments that may bring ‘little or no benefit to patients’, with the advice that ‘more doesn’t always mean better’. As part of its Choosing Wisely UK campaign, the AMRC urges patients to ask their doctors the following five questions about their treatment.
- Do I really need this test, treatment or procedure?
- What are the risks or downsides?
- What are the possible side effects?
- Are there simpler, safer options?
- What will happen if I do nothing?
“Under no circumstances should a woman stop taking her drugs without consulting her GP or neurologist,” Sanders said. “This is why preconception counselling is so important.”
The AMRC represents 21 medical colleges in the U.K.