Published: Sat, January 13, 2018
Medical | By Johnnie Horton

FDA putting new limits on cold medicine for children

FDA putting new limits on cold medicine for children

The Food and Drug Administration will now require labeling changes on prescription opioid medicines that contain codeine or hydrocodone.

The FDA wants to warn the public about the risk of misuse, abuse, addiction, overdose, death, and slowed or hard breathing that can happen with codeine and hydrocodone.

Gottlieb also cited the ongoing epidemic of opioid addiction, and stressed the importance of reducing exposure to addictive drugs at a young age. Both are opioids, meaning they're either derived from an opiate or they are synthetic, and are part of a family of narcotic drugs that are highly addictive.

The FDA is putting new limits on the amount of prescription cold and cough medicine that children should be given. "At the same time we're taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products". Labeling changes also address safety information for adults, including an expanded boxed warning indicating the risks of using opioid medications, such as misuse, abuse, addiction, overdose, and death.

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The revised safety warnings on these products will be consistent with the labeling of other opioid-containing drug products, such as immediate-release opioid analgesics and extended-release and long-acting opioid analgesics, according to the FDA. Previous year the restrictions were expanded to include safety labels that carried the contraindication warning, the FDA's most severe warning, to say that it should not be used for patients under the age of 12.

These requirements made on Thursday pertain to medicines containing codeine or hydrocodone in children younger than 18-years-old. Experts indicated that although some paediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment. They must now indicate that the products no longer can be used to treat children because the risks outweigh the potential benefits.

Common side effects of opioid use include headache, vomiting, dizziness, breathing difficulties and even death. "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". Caregivers should also read labels on non-prescription cough and cold products.

Some codeine cough medicines are available OTC in a few states, and FDA is also considering regulatory action for these products. They believe the risks outweigh the benefits.

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