Did a banned drug 'Perinorm' kill 10 year old Ahmed? :: Maldives News :: Dhivehi Observer

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Ahmed was playing in the morning like any other 10 year old, few hours later he was dead after receiving medication from the hospital

Did a banned drug 'Perinorm' kill 10 year old Ahmed?

12 September 2006

Male' - According to sources within the family of Ahmed Jazleen who died suddenly after receiving medication for vomiting from IGMH, government hospital in capital Male', he was given a number of injections after he was diagnosed by Dr. Sushma (ID: 26200). According to the ER service record sheet, Ahmed was given 3 injections, Buscopan, Perinorm and Renitidine, in addition to Paracetamol and IV. The most controversial of these is Perinorm, which is supposedly a banned drug for under 20 year olds globally, according to experts (please refer to the article below).

"Like in India, Perinorm is commonly prescribed here in the Maldives but we do keep the patient for observation for a few hours, just in case there is a side effect," said a medical officer working at IGHM. When told that Ahmed had been sent home immediately after the injections, the officer said "That should not have happened, but here there is no one to take responsibility, the management and the ministry does not taken this kind of professional misconduct seriously."

There were reports that some family members of Ahmed went to the hospital yesterday and confronted Dr. Sushma and even physically assaulted her due to which some doctors in the hospital are now on strike. However, the medical officer that we spoke to in IGMH denied this news.

Delhi Newsline
Perinorm: Banned drug finds place on shelves
by Toufiq Rashid, June 2, 2003 (source)

New Delhi, June 1: Even as the Nimesulide debate refuses to die, the recent case of a death of a two-year-old boy after being given a Perinorm injection, has once again brought into focus the use of banned drugs, unethical medical practices and lax drug control system in the country.

Metoclopramide - sold under the brand names Perinorm and Reglan - is prohibited for use in people below 20 years globally. Ironically, its use is permitted for newborns in India.

Experts say the manner of administration doesn't matter, both its oral and injection forms are banned.

Tragedy struck two-year-old Akash's family while they were in the Capital to attend a wedding in Sarita Vihar. Akash fell ill and began vomiting. The parents took him to a nearby doctor where he died within hours of being given the drug. Akash reportedly died of acute dystonic reaction - when various muscles in the body start contracting on their own - a side-effect of metoclopramide, known to occur predominantly in children and adolescent.

Introduced in 1980, metoclopramide, as per annual estimates, does a business of about Rs 40 crore in the country. However, in 1995 it was contradicted, and its use was globally prohibited not only in children but in all below the age of 20.

"On the basis of side effects encountered during post-marketing analysis, the use of metoclopramide was severely restricted in the US, UK Australia and rest of the world in 1995. Its use as an anti-emetic in patients below 20 years is permitted only during cancer therapy," says Dr Chandra M. Gulati, Editor, Monthly Index of Medical Specialities, India, and former drug expert with WHO.

Dr Gulati says the drug literature provided with Perinorm allows its use for nausea and vomiting for all, right from a low-weight newborn to a person at the fag end of life. Another brand, Reglan is less forthcoming, it does not supply information regarding side-effects with the product.

"When we quizzed pharmaceutical companies on the obvious error in recommending the use of Perinorm in infants and toddlers, the company admitted that their package insert had not been amended since early 80s and that they ‘may' change the prescribing information when the package insert is revised," said Dr Gulati.

The doctors, however, admit that the drug is not listed in the restricted category. "It is used everywhere including government dispensaries. The doctors prescribe as it is not banned in the country," says Dr Anil Bansal, president, Delhi Medical Association.

Another interesting fact about perinorm is that while the literature suggests "there are no adequate and well controlled studies in pregnant women, hence Perinorm should be avoided in the first trimester of pregnancy", a promotional leaflet distributed to doctor calls it the "first choice anti-nauseant, anti-emetic" in the first trimester "without any risks".