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HEALTHLINE NEWS

FDA on the Verge of Banning Codeine in Cough Syrup for Children

A Food and Drug Administration advisory panel nearly unanimously deemed the medication risky for people under the age of 18.

Cough Syrup for Children

The practice of prescribing children’s cough syrup that contains codeine may soon be a thing of the past.

This week an advisory panel for the Food and Drug Administration (FDA) voted nearly unanimously against giving children cough syrup with opiates, including codeine.

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The panel of 24 experts debated and voted on a variety of recommendations around children’s cough syrup.

The 24 experts voted unanimously that the risks of giving adolescents under age 18 cough syrup with codeine outweigh the benefits of getting that cough suppressant, if the adolescents have symptoms due to allergies or the common cold.

They also voted 23 to 1 that the risks outweigh the benefits of giving children cough medicine with the opiate hydrocodone.

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They also voted 21 to 2 (with one panel member abstaining) that the risks outweigh the benefits of prescribing general opioid cough suppressants for treatment of cough in pediatric patients.

The vote comes months after the FDA restricted doctors from prescribing medication with codeine to children under the age of 12.

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There is not yet an indication of when or if the FDA will expand that restriction to children and adolescents between the ages of 12 and 18.

In a statement to Healthline, FDA press officer Michael Felberbaum said the agency “will continue to share updates with the public on the steps the agency is taking to address this important issue.”

“The FDA’s advisory committees provide independent, expert advice to the agency on a range of complex scientific, technical, and policy issues,” he wrote in an email to Healthline. “Although advisory committees provide recommendations to the agency, the FDA makes the final decisions.”

Decision is praised

For experts in the field, the news was welcomed as a way to protect children and young adults from dangerous complications associated with the drugs.

Dr. Donna Seger, the medical director and executive director of the Tennessee Poison Center, said codeine cough syrup, in particular, has been associated in rare cases with children developing respiratory depression from the medication.

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“There are people called fast metabolizers and slow metabolizers,” she told Healthline. “The kids who metabolize it fast can get respiratory depression.”

In rare cases, respiratory depression from cough syrup has resulted in hospitalization and even death. The FDA has found that medications containing codeine have resulted in at least 26 deaths since 1969.

Seger said she was less concerned that children would abuse cough syrup for an opiate high, especially if they’re only exposed to the medication for a few days.

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She instead said she had more concerns about teenagers abusing cough syrup with Dextromethorphan (DXM), which can result in euphoria.

“It was and still is abused as a hallucinogen,” she explained.

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Cough medication effectiveness

Dr. Sophia Jan, director of general pediatrics at Cohen Children’s Medical Center in New York, said children should not be given cough syrup with opiates, especially since she said there isn’t good evidence that any cough syrup works well in general.

“First, cough syrup, with or without codeine, is not effective in children,” Jan said in an email statement to Healthline. “Yet cough medicines are some of the most common reasons for overdose and calls to poison control centers. The over-the counter components of these medications have multiple side effects, while the narcotic portion of these medicines can cause kids to stop breathing.”

At the meeting on Monday, some of the experts on the panel reportedly expressed concern there’s little evidence this medication would suppress cough effectively and that it can cause dangerous reactions.

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“I haven’t… ever been taught that morphine is an appropriate anticough medicine,” Dr. Kelly Wade, a neonatologist at the Children’s Hospital of Philadelphia was quoted as saying by STAT News.

She added, “This is really historic and antiquated cough medicine.”

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The opioid crisis

While older children may be at less risk for respiratory depression associated with codeine cough syrup, Jan pointed out that teens and young adults could abuse cold medicine in an attempt to get high.

“The brains of children, adolescents, and young adults are not fully formed, and consequently have immature judgment,” she said. “Exposure to opiates only impairs judgment even more, and placing children at higher risk for unintentional injury.”

She also said that with the ongoing opioid crisis in the United States, doctors should not expose children unnecessarily to opiates, even if it’s just for a few days via cough syrup.

“There are clearly children and adults who are more prone to addition to opiates based on genetics, which we do not fully understand yet,” she said. “We should not be contributing to our country’s opiate addiction problem by exposing children and adolescents to narcotics at such a young age.”

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