The Hindu : Perinorm: A wrong prescription for children?

Online edition of India's National Newspaper
Thursday, May 22, 2003

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Perinorm: A wrong prescription for children?

By Bindu Shajan Perappadan

NEW DELHI MAY 21. Early this month a two-and-a-half-year-old boy in Delhi's Sarita Vihar area died hours after he was brought to the hospital with nausea and excessive vomiting. The boy had been prescribed Metoclopramide Hydrochloride (Perinorm), a drug widely used in India for treating children with nausea and vomiting. Actually the drug is banned for use by children below 18 years for nausea and vomiting caused by gastroenteritis.

Sadly, misuse of the drug is so prevalent and information about it so meagre that caution has been thrown to the winds. The drug is easily available at almost every chemist's shop everywhere in tablets, syrup and injection and does a Rs.40- crore business annually, 50 per cent of which is shared by Perinorm.

Metoclopramide Hydrochloride was introduced in the early 1980's and after over a decade it was found that persons below 18 years using the drug were at risk. By 1995 it was contra- indicated all over the world. India, which should have followed the guideline issued on the adverse reaction of the drug, chose to ignore the same and continued to provide the "selective- fraud'' as treatment.

According to doctors in India, the drug is widely prescribed for children who come with complaints of nausea and vomiting. "The drug is widely prescribed for children and is used to treat nausea and vomiting. We, however, ensure that the use of the drug is justified and that the child will benefit from the same,'' they claim.

This even as the U.S. Federal Drug Administration in America does not permit the use of the drug for people below 18 years for controlling nausea and vomiting, according to the Medicine Control Agency. For Indian children, however, these rules don't hold much significance.

In India, the drug is recommended for relieving nausea and vomiting induced by gastroduodenal disorders like flatulent dyspepsia, gastritis, gastroenteritis, duodenal ulcer, hiatus hernia, biliary disorders, uremia, cardiac disease, radiation therapy and migraine -- and for drugs like Digitalis, Metronidazole, Pethidine and Morphine including cancer chemotherapy. The rules clearly tilt in favour of the drug manufactures and have little regards for the user.

Our country permits the use of the drug in infants weighing 2 kg and over. And as if the harm done to the children is not enough, the company has been promoting yet another dubious campaign. While the literature provided by the company (Perinorm) says "since there is no adequate and well controlled studies in pregnant women, Metoclopramide should be avoided in the first trimester of pregnancy and could be used in second and third trimester of pregnancy only if clearly indicated.''

Another set of literature claims that (Perinorm) "is the first choice anti- nauseant antiemetic for pregnancy induced nausea and vomiting.'' Justifying the two sets of literature the company (Perinorm) says that their literature has not been updated since 1980's and same shall be done as soon as possible.

The horror does not end here. Metoclopramide Hydrochloride in combination is not permitted according to a notification GSR- 603 (E), the rule came into effect by September 1, 2002. Combination of the drug continues to be manufactured by a Kolkata-based company is available in the market.

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