Drugs containing codeine should not be prescribed to children younger than 12 and breastfeeding women unless there is no alternative, the Food and Drug Administration (FDA) announced on Wednesday.
Several cases have been reported abroad of children developing breathing problems after taking drugs containing codeine.
FDA official Chi Jo-feng (祁若鳳) said that codeine treats pain and coughing, but people’s metabolic rates can vary and breathing problems have occurred in some cases.
Although in Taiwan there has been no reported case of serious respiratory malfunction caused by codeine in children or teenagers younger than 18, the agency’s drug safety evaluation and consultation group decided to modify its usage guidelines, as there are alternative drugs, she said.
Chi said drugs containing codeine are not allowed to be prescribed to children younger than 12 and breastfeeding women unless there is no alternative drug option or the clinical benefits are greater than the risk.
If doctors are to prescribe such drugs to children, they should carefully evaluate the clinical benefits and risks and inform the patient and their caregiver to look out for signs of breathing problems, such as slower or weaker breathing, difficulty breathing, noises when breathing, confusion, sleepiness or weakness, she said.
The FDA has sent letters to pharmacies saying they should inform people about the possible side effects from consuming pain relief or cough medicine containing codeine, Chi said, adding that parents should also stop giving children cough syrup or pain killers that contain the ingredient.
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