Thursday, March 19, 2009

NEWS: NDA lists syrups in investigation


NDA lists syrups in investigation from DAILY MONITOR ONLINE

The National Drug Authority has named 12 infant syrups whose safety and efficacy it is investigating.

A spokesman for the NDA, however, says parents should not panic and pharmacists should not withdraw the listed syrups from their shelves until the investigation is complete.

The NDA investigation comes after doctors in the United States, Kenya, and the World Health Organisation raised concerns about the efficacy of the syrups, most of which are used to treat coughs and colds in infants.

NDA spokesperson Fred Ssekyana told Daily Monitor that the investigation is focusing on 12 syrups that are registered and on sale in Uganda. He said the NDA would not issue an advisory for or against any of the listed syrups unless investigations conclude that they are harmful or useless to children.

“We are dealing with sensitive issues; we cannot work on hearsay,” Mr Ssekyana said. “The raised concerns have to be scientifically investigated until we get an evidence-based conclusion.”

The NDA spokesman said the investigation is covering the following syrups: Actifed Wet (Cough and Cold) Syrup 100ml, Actifed Compound Linctus (Dry and Cold Cough), Ascoril syrup 100ml, Benylin Expectorant Syrup 100ml, Benylin Pediatric Syrup 100ml and Benylin with Codiene Syrup.

Others are Bisolvon Elixir 100ml, Bro-zedex cough Syrup 100ml, Cadistin Expectorant 100ml, Linctifed forte syrup 100ml, Linctifed Paediatric Syrup 100ml, and Piriton Expectorant 100ml.

The spokesman said the NDA routinely inspects drugs prescribed and sold in the country.
“This is part of the usual work we do only that we do not always announce that we are going to do it,” he said. “We do it randomly and in an intelligent way. The dispensers should not be in the know; otherwise it would defeat the purpose.”

A senior official in the Health Ministry yesterday called for a speedy investigation into the matter to help parents and health practitioners make informed decisions about which medicines to give or not to give.

Dr Jeremiahs Twa-Twa, the acting assistant commissioner for health services in the Child Health Division, said: “The advice that can be given to parents is that the best approach to the situation is to always consult with their health workers on what medications to give their children.”

Syrups are popular among parents and many doctors because they are sweet and therefore easy to administer to children, and can also be bought over-the-counter.

Many parents have, however, been left with a bitter taste in the mouth after the US-based Centers for Disease Control and Prevention in 2007 warned against giving syrups to children after the deaths of three babies were linked to the toxic effects of cough and cold medicines.

A CDC study showed that more than 1,500 toddlers and babies wound up in emergency rooms between 2004 and 2005. Consequently, the CDC warned parents against giving common over-the-counter cold and cough remedies to children under two years without consulting a doctor.

In Kenya, top health facilities, including the Aga Khan University Hospital, are discontinuing the use of such syrups. In a public statement issued this week, the chairperson of the Kenya Pharmacy and Poisons Board said the reported syrups were neither being recalled nor banned.
Dr Francis Kimani, however, added that use of the syrups among children under 6 years “is not recommended but can only be used under prescription”.

Ugandan doctors started weighing in on the debate yesterday with Dr Vincent Ojoome, a senior consultant pediatrician, calling for caution in the administration of syrups to children.

“We are trying as much as we can to discourage the use of cough and cold syrups especially those that have sedative elements because they can be detrimental,” Dr Ojoome, who is also the medical superintendent at Mbale Regional Referral Hospital, said. “They give a false sense of security.”

He, however, emphasised that some syrups – for instance antibiotics – are vital in the management of infection.

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