IMA issues advisory on the use of Sodium Valproate in pregnant women
Considering the multiple adverse effects of using Sodium valproate in pregnant women, IMA issues advisory to its 2.8-lakh members across the nation
New Delhi, Jan 02, 2017: Sodium valproate or valproic acid is a prescription drug indicated in cases of Epilepsy to control seizures, bipolar disorder and migraine headaches. Clinical research has shown that sodium valproate can cause serious complications in a developing baby and may lead to multiple congenital disorders.
According to the Medicines and Healthcare Products Regulatory Agency (MHRA) taking sodium valproate during pregnancy can cause birth defects (10% of cases) or problems in development and learning as the baby grows up (40% of the cases). WHO has already issued an advisory against the use of the drug in women who are pregnant or who have attained childbearing age.
Padma Shri Awardee Dr. K.K Aggarwal, President Heart Care Foundation of India (HCFI) and National President Indian Medical Association (IMA), stated that, “In India, sodium valproate is most commonly used to treat seizures associated with epilepsy. In a minority of cases, it is also prescribed for Bipolar disorders. However, taking sodium valproate during pregnancy can increase the likelihood of developing major and minor birth defects including spina bifida and cleft palate. It can also cause neurodevelopmental defects and learning associated disabilities later in life including memory problems, speech impairment and cognitive decline. Moreover, the drug also carries a high-risk in women who are not pregnant but are of childbearing age.”
The IMA-PvPI (Pharmacovigilance program of India) nodal center monitors adverse drug events and spurious drug use throughout the country. It’s database reveals that the drug is still being prescribed in India amongst high- risk patients.
“Up to 40% of women who take valproic acid during the course of their pregnancy experience adverse effects. This calls for stringent measures in halting the wrongful prescription of this drug. Moreover, this also calls for stronger warnings on the drug’s information leaflets. IMA’s guidelines for Sodium valproate clearly state that doctors must explain the drugs potential risks to an unborn child while prescribing it to women living with epilepsy”, added Dr. Aggarwal.
While prescribing sodium valproate to pregnant women with epilepsy, it is imperative to weigh the benefits and risks of the drug properly before taking clinical decisions. The drug should only be used as a last resort where no alternative is available. Doctors should also talk to their patients about avoiding conception while on the drug
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About IMA: Indian Medical Association is the only representative, national voluntary organization of Doctors of Modern Scientific System of Medicine, which looks after the interest of doctors as well as the well being of the community at large. It has its Headquarter in Delhi and State / Terr. Branches in 29 States and Union Territories. It has over 2, 53,000 doctors as its members through more than 1650 active local branches spread across the country.
