The Hindu : Karnataka News : Study on anti-epileptic drug for pregnant women

Online edition of India's National Newspaper
Monday, May 31, 2004

Karnataka

Karnataka

Study on anti-epileptic drug for pregnant women

By Sahana Charan

BANGALORE, MAY 30. Are you an expectant mother with epilepsy worried about how the drugs that you are taking may affect your child?

The Department of Pharmacology at St. John's Medical College and Hospital has news for you.

It has initiated work on a registry of "anti-epileptic drugs and pregnancy" to study whether anti-epileptic drugs consumed by expectant mothers with epilepsy have adverse effects on the foetus or not.

Epilepsy is a disorder of the nervous system in which abnormal electrical activity in the brain causes convulsions. Drugs that control the occurrence of such seizures are called anti-epileptic drugs.

Chanda Kulkarni, Professor and Head of the Department of Pharmacology at the hospital, said the number of anti-epileptic drugs used in the treatment of epilepsy had been increasing and many new drugs had been introduced in the market recently.

Studies were conducted in the Seventies in other countries to assess the effect of anti-epileptic drugs on the foetus and to check for foetal malformations. But no data was available in India to prove whether or not certain anti-epileptic drugs were safe than others during pregnancy.

"It should be understood that treatment for epilepsy, especially during pregnancy, is a must as the disorder can adversely influence the growth of the foetus. At the same time, we have to find out how safe the drugs used in the treatment are. The study is only an observational one and no treatment modifications will be made. All information will be confidential," she said.

Other departments in the hospital will be involved in the study. Apart from Dr. Kulkarni, the investigators are Sujata Sowmyanarayan and Daniel Pais, both from the Department of Pharmocology; Arun Maskar, Obstetrics and Gynaecology Department; A.K. Roy and Sharma, both from Neurology Department; Swarnarekha, Paediatrics Department, and Babu Philip, Radiology Department.

The Pharmacology Department, which is the Bangalore centre for the Indian Registry of Epilepsy and Pregnancy (IREP), will forward the data collected by it to the national registry, the first such registry being prepared in India.

It will in turn pass it on to EURAP (central registry). EURAP, based in Milan, Italy, is a consortium of independent research groups for assessment of pregnancy outcome after prenatal exposure to anti-epileptic drugs and for establishing a registry of anti-epileptic drugs and pregnancy.

Dr. Kulkarni told The Hindu that similar studies are being conducted in Visakhapatnam, Ludhiana, and Thiruvananthapuram.

She said a pilot study of 30 patients had been conducted in the last one year and it would now be extended to a larger number.

The centre planned to maintain a record of and monitor at least 2,000 patients over a two-year period. Pregnant women on epileptic drugs might register directly with the centre or through their doctors, she said.

The study would help in identifying drugs that were safe for consumption for epileptic women at childbearing age.

"The data collected will help in counselling for pregnant women with epilepsy. We propose to formulate specific treatment guidelines based on the information gathered," she said.

The centre planned to approach the State Government for funding so that pregnant women with epilepsy would be motivated by an honorarium to participate in the study. Interested persons can call 22065045.

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