Health Alert: FDA warns of opioids in cold medicines

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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.

These prescription medicines involve any that include codeine or oxycodone, the FDA said.

FDA Commissioner Scott Gottlieb, who has made battling the opioid epidemic a top priority, said in a statement Thursday that it is critical "to protect children from unnecessary exposure" to prescription cough medicines containing codeine or hydrocodone.

As a result, FDA is requiring several changes to the labels of all prescription medicines containing these drugs. They must now indicate that the products no longer can be used to treat children because the risks outweigh the potential benefits. FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.

Common side effects of opioid use include headache, vomiting, dizziness, breathing difficulties and even death.

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The FDA also said it is requiring manufacturers to add new safety warnings for adult use - including an expanded box warning, the most prominent kind - spelling out the risks of using medications with codeine and hydrocodone.

Though the FDA's warning substantially decreased codeine prescriptions among children after tonsillectomies or adenoidectomies, about one in 20 kids undergoing those surgeries still was prescribed codeine in December 2015, despite safety concerns and efficacy issues, according to a study published in the journal Pediatrics in November. The FDA also held an expert roundtable and convened a meeting of its Pediatric Advisory Committee to look at all the risks associated with the use of codeine- or hydrocodone-containing cough and cold products in children and adolescents younger than 18-years-old.

The new rules announced Thursday were "based on an extensive review of available data and expert advice", the agency said.

The agency also noted that some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children, so it's important to check the labels. If a cough medicine is prescribed, ask your child's health care professional or a pharmacist if it contains an opioid such as codeine or hydrocodone.

The FDA will remind parents that most coughs and colds don't need any treatment at all. Always read the labels on prescription bottles. "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.