NEWS:NDA clears questioned cold syrups

NDA clears questioned cold syrups

Monday, March 23, 2009 from MONITOR ONLINE

The National Drug Authority yesterday gave a clean bill of health to the 12 cough and cold syrups for children that the regulatory body was investigating, saying they are neither poisonous nor dangerous if taken as recommended by a healthcare provider.

And while the NDA described the syrups as being of “good quality, safe and efficacious”, the regulator indicated that they are not a cure, saying they can only relieve symptoms.

“Cough and colds occur frequently in children and will usually get better by themselves, however, cough and cold medicines provide symptomatic relief,” read a statement signed by Mr Gabriel Kaddu on behalf of the NDA’s Executive Secretary/Registrar.

The NDA last week announced an investigation into the medicines 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.

The syrups that have been under investigation include Actifed Wet (Cough and Cold) Syrup 100ml, Actifed Compound Linctus (Dry and Cold Cough), Ascoril syrup 100ml, Benylin Expectorant Syrup 100ml, Benylin Paediatric Syrup 100ml and Benylin with Codiene Syrup, some of the most popular on the Ugandan market.

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.

Mr Kaddu said yesterday: “There is no cause of alarm and panic among parents and guardians since the syrups are neither poisonous nor dangerous when taken as recommended by healthcare provider.”

“[The] NDA wishes to state that these medicines are neither being recalled, withdrawn nor banned from the market because there is no sufficient evidence to do so,” the statement added.

The agency none-the-less called upon all health workers and the public to report any suspected Adverse Drug Reaction and any quality issues related to drugs to the regulatory body.

The NDA also gave hospitals and other health facilities the green light to amend their lists of essential medicines, but the amendments are limited to the respective institutions.

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.

But Uganda’s statutory body insisted that they have in place adequate quality assurance mechanism to ensure that only good quality, safe and efficacious medicines are available to our population.