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FDA Urged To Ban Over-the-Counter Codeine Products

The Food and Drug Administration has recently been advised by medical professionals that children should not be treated with prescription drugs that contain codeine. Currently, teens and youth can be prescribed a codeine infused product that can help them to address their cough. Last Thursday, medical advisors overwhelmingly voted to ban the sale of over the counter codeine cough syrups for children due to the dangers. Currently, there are 28 states in the U.S. that allow codeine cough syrups to be sold without a prescription.

This vote came after a daylong joint meeting between the Drug Safety and Risk Management Advisory Committee and the FDA's Pulmonary-Allergy Drugs Advisory Committee in Silver Spring, MD. While the FDA is not required to meet or follow the suggestions regarding codeine cough syrup or any other medical recommendations, they usually do.

This decision came because several of the committee members expressed concern about whether codeine is an effective antidote for a child's cough. They suggested that there may be safer alternatives to offer. Maria Pruchnicki from the Ohio State University College of Pharmacy stated that she would be uncomfortable prescribing codeine products to children for coughs because she would be worried about killing them with too high of a dosage.

These types of worries for child safety has led to a dramatic decrease in the sales of codeine-related products for children, but doctors can still prescribe it and parents are able to buy cough remedies that have codeine in them without a prescription across the US. The FDA has become increasingly worried about codeine being used by children as it has been found to cause life-threatening breathing issues in some children. While it is a great option for children who are recovering from surgery, some agencies are certain that it should be regulated for only surgical use for children even though life-threatening complications are very rare.

The FDA had convened a panel of experts outside their agency to advise them on a course of action. During this hearing, scientists showed evidence of dozens of cases in which small children and teens stopped breathing after receiving medication with codeine in it. Some of these cases were from the last decade, leading a variety of advocacy groups to follow the lead of codeine regulations in Australia, Europe, and Canada. These countries have sharply regulated the use of codeine products. In short, the recommendations state that codeine should not be used in a cough related treatment of children, or for pain. They pediatricians' group recommended that the FDA ban the sale of any codeine products without a prescription as well. The Consumer Healthcare Products Association which was representing companies that manufacture and sell over the counter codeine products urged the FDA to consider their decision carefully. They reminded the agency that codeine has long been considered to be a safe and effective choice for a variety of illnesses and that making the choice to remove codeine products from over the counter sales should be a longer process instead of quickly done.


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