Labeling rules gets strict by FDA to save children

FDA revises labelling in prescription cough and cold products to protect children from opioids

Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Parents of children now prescribed a cough and cold medicine containing codeine or hydrocodone should talk to their child's health care professional about other treatment options, according to the FDA.

In September, the FDA met with the Pediatric Advisory Committee to determine the dangers associated with using opioids in children's cough medicine.

The safety labeling changes will require that the medicines have labels that no longer indicate that such drugs are appropriate for anyone under the age of 18.

Labeling for these medications will also be updated with additional safety information for adults, including an expanded boxed warning.

The new warnings are consistent with the labels on other drug products with opioids, including painkillers.

"Given the epidemic of opioid addiction, we're concerned about unnecessary exposure to opioids, especially in young children", says FDA Commissioner Scott Gottlieb.

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Parents and caregivers should be aware that prescription opioid cough and cold medicines that include codeine or hydrocodone should not be used in children.

The move follows efforts a year ago to restrict the use of codeine- or tramadol-containing OTC medicines in children and breastfeeding mothers. "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".

The required safety labeling changes announced today are based on an extensive review of available data and expert advice shared at meetings to explore the pediatric use of opioid-containing cough and cold products.

A new Warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.

According to the agency, outside experts said that while some children's coughs require treatment, many get better on their own - including ones that are the result of respiratory infections. Common side effects of opioids include headache, dizziness and vomiting.

It's always important to read medicine labeling, too - even if it's not obtained by prescription. They believe the risks outweigh the benefits.

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