Parents have been warned not to give toddlers over-the-counter cough and cold remedies unless advised to do so by a healthcare professional.
The Medicines Control Council (MCC) has warned parents not to give toddlers over-the-counter cough and cold remedies unless advised to do so by a healthcare professional.
MCC registrar Mandisa Hela said on Friday that the body is investigating the safety of the remedies for children under two years old.
“This is in response to the international and local reports about serious life-threatening adverse events, including unintentional overdoses, when these products have been used in infants and toddlers,” she said in a statement.
“These cases have occurred as a result of incorrect dose or dosing frequency as well as the use of more than one cough and cold preparation at a time.”
Experts at the United States’s Food and Drug Administration (FDA) late last year urged the agency to ban non-prescription cough and cold medicines for children under the age of six.
Their call followed reports of serious side effects, including increased heart rates, convulsions and decreased levels of consciousness, and the deaths of 54 infants.
After the FDA announced it would probe the safety of the remedies, US pharmaceutical manufacturers voluntarily recalled 21 children’s cough and cold medicines.
Hela said the MCC has asked all manufacturers of the remedies to provide information on the safety of their ingredients for children under two years. “Once the MCC has reviewed all available information, regulatory actions will be taken to improve the safe use of cough and cold medicines in South Africa.”
While these investigations are under way, the MCC urges parents and caregivers to avoid giving cough and cold medicines to children under two years unless instructed to do so by a qualified doctor or pharmacist.
“A healthcare professional should be consulted even if the product information in the package insert or patient information leaflet allows the use in children under two years of age,” Hela said.
It is advisable not to give more than one cough and cold product to a child at the same time. Using two with the same or similar active ingredients could result in an overdose. Parents should read the dosing instructions carefully, and use only the measuring spoons or cups that come with the medicine. They should not use these medicines to sedate their children or make them sleepy.
“It is important to understand that cough and cold medicines do not treat the cause of the symptoms and do not shorten the length of time your child is sick,” Hela said. “They only relieve symptoms and make children more comfortable.
“These symptoms can also be managed by rest, sufficient fluid intake and by making the child feel comfortable and comforted.”—Sapa