The U.S. Food and Drug Administration announced on Wednesday that it would re-evaluate the safety of cough syrup use, especially those that contain codeine, for children.
The agency is investigating how safe codeine use is in children below 18 years as it is known to carry potential health risks, including difficulty in breathing.
The decision to review cough syrup use comes after an April 2015 ruling from the European Medicines Agency (EMA), which said such preparations were not appropriate for use in children below 12 years old.
The agency also advised against its use by teenagers with breathing problems. The FDA said it would create an advisory committee to evaluate safety concerns over the use of the drug.
Codeine is an opiate usually prescribed to treat pain, but it is also used in combination preparations such as in cough and cold formulations. Codeine undergoes metabolism in the body and breaks down into morphine. In some people, especially children, the drug does not break down easily, and more doses will be needed to reach the therapeutic effect, leading to an overdose.
At the same time, there are also those who tend to metabolize the drug too quickly, leading to accumulation of morphine levels in the blood, also resulting in an overdose.
"The FDA will continue to evaluate this safety issue and will consider the EMA recommendations. We will convene a public advisory committee meeting to discuss these issues and provide input regarding whether additional action by the FDA is needed," the official announcement from FDA reads.
The American Academy of Pediatrics has warned against prescribing the formulation to children in 1997. But doctors seem to have ignored the warning.
In 2014, a published study revealed that more than 870,000 codeine prescriptions were still written for children of all ages from 2001 to 2010.
Meanwhile, parents are advised not to give codeine-containing cough medicines and seek immediate medical attention if they observe any signs of difficulty in breathing, which include unusual drowsiness, shallow breathing and noisy breathing.
