FDA to Look at Risks of Treating Children with Codeine
WASHINGTON, July 2 (UPI) — Two years after issuing a strong warning against giving children codeine following surgery, the Food and Drug Administration will investigate the risks of using cough and cold medicines that include the drug to treat children in any situation.
The drug, which is prescribed to to approximately 870,000 children in the U.S. each year according to a recent study, helps suppress coughs during a bad cold or sinus infection but can cause breathing difficulties.
The FDA announced in a press release it would consult experts and form an advisory council to investigate safety issues associated with giving codeine to children, suggesting in the meantime parents pay extra attention to their children’s breathing.
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“Parents and caregivers who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness in their child should stop giving their child codeine and seek medical attention immediately by taking their child to the emergency room or calling 911,” the agency advised.
Codeine affects the way the brain processes pain, in the case of coughing by decreasing activity in the part of the brain which causes it. Once taken, the body converts codeine into the opioid morphine. Since people’s bodies convert codeine at different speeds, the potential for overdose is high because either the drug can be converted too quickly or more could be taken by the patient due to a lack of effect from the first dose. This can lead to high levels of morphine in the blood, which can be dangerous.
The move by the FDA follows the European Medicines Agency announcement in April that codeine must not be used with children under the age of 12 and is not recommended for children between the ages of 12 and 18 who have chronic breathing problems such as asthma.
In 2013, the FDA warned against giving codeine to children following surgeries to remove tonsils or adenoids.
More than 870,000 prescriptions are written each year in the U.S. for children for drugs that include codeine, with children between the ages of 8 and 12 receiving a large proportion of those prescriptions.
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