FDA Orders Labeling Changes For Certain Cough And Cold Medicines

FDA Releases New Requirements For Prescription Opioid Cough And Cold Medicines

FDA Orders Labeling Changes For Certain Cough And Cold Medicines

On Thursday, the FDA announced it is requiring the changes in order to limit the number of children using prescription opioid cough medicines and cold medicines containing codeine and hydrocodone.

In addition to limiting use in children following a comprehensive assessment of the risks and benefits of these products, labelling for adult-only use of prescription opioid cough and cold medicines that contain codeine or hydrocodone will also now include updated safety information.

FDA is taking this action after conducting an extensive review and convening a panel of outside experts. It's become clear that the use of prescription, opioid-containing medicines to treat a cough and cold in children comes with serious risks that don't justify their use in this vulnerable population", said FDA Commissioner Dr Scott Gottlieb, "It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone. They must now indicate that the products no longer can be used to treat children because the risks outweigh the potential benefits. Some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children. Labeling for the drugs is also being updated with additional safety information for adult use, including an expanded boxed warning, warning of the risks of misuse, abuse, addiction, overdose and death, and slowed or hard breathing that can result from exposure to codeine or hydrocodone.

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"Experts indicated that although some pediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment", the agency said.

Parents whose children are now prescribed cold or cough medication containing codeine or hydrocodone are encouraged to talk with their doctors about other treatment options. "We know that some children and teens may, in fact, develop a predilection for the "high" the prescription cough syrups deliver, and subsequently attempt to deceive parents and health care providers regarding the severity of their symptoms to obtain such a prescription". For those children in whom cough treatment is necessary, alternative medicines are available.

"There's no reason for any primary care doctor to prescribe opioids" to children, she said. Caregivers should also read labels on non-prescription cough and cold products.

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Katie McPeak, medical director for primary care with St. Christopher's Hospital for Children, called Thursday's announcement a positive step because it will raise even more awareness about the opioid epidemic.

In 2015, the FDA also announced an investigation into the possible risks of using codeine-containing medicines to treat coughs and colds in children under 18.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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