JAKARTA, NETRALNEWS.COM - The United States Food and Drug Administration (FDA) has reminded that children under the age of 12 years or breastfeeding mothers should not be prescribed drugs containing codeine, tramadol because it is harmful to them.
The FDA study found that 21 codein-related deaths occurred in children under 12 and there were more than 60 cases of severe respiratory problems over the past five decades.
Codeine is an opioid drug often contained in cough syrup that is sold freely and as a painkiller, especially after surgery. But the report notes that the old genetic variations cause some people to digest them too quickly resulting in excessive sleepiness and difficulty breathing.
As quoted from npr.org on Friday (4/21), there are some prescription drugs containing codeine or tramadol. For example, Tylenol 3 painkillers contain acetaminophen and codeine.
Codeine is often prescribed to relieve pain after a surgical removal of the tonsils. However, the FDA has banned from using it. Surgical removal of tonsils is sometimes recommended to treat enlargement of the tonsils that cause sleep apnea, a common condition to stop breathing during sleep.
According to the FDA, this condition has been linked to obesity and children who have sleep apnea during sleep are particularly susceptible to breathing difficulties caused by codeine. So the FDA prohibits patients aged 12-18 years who are obese or lung disease as well as sleep apnea not to use codeine.
"Codeine is an effective drug when used properly, (but) they can cause a lot of harm when its use is incorrectly," said Deputy Director of the Regulatory Program at the FDA's Center for Drug Evaluation and Research.
The FDA also recommends that parents talk to a doctor before they prescribe drugs for the child. The FDA also notes that cough colds in children are generally mild and can disappear within a few days.
"So maybe the kids do not need to take any medication if cough and runny nose," FDA explained.
The FDA announcement on Thursday (20/4/2017) is a follow-up of the 2015 recommendation issued by the Independent Advisory Committee which recommends that the FDA limit the prescription of drugs containing codeine for children.
Regulators in Europe, Canada and Australia prohibit the use of drugs containing codeine for children. According to the FDA's public label database, more than 100 drugs containing codeine are approved for sale without a prescription in the US.