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FDA advisory committee rejects opioids in children’s cough syrup


 

AT AN FDA PEDIATRIC ADVISORY COMMITTEE MEETING

– The majority of a Food and Drug Administration advisory panel agreed the benefit versus risk of prescription opioid cough suppressants for pediatric patients was not favorable.

The voting was broken into multiple votes based on age range of patients and the specific opioid present in the cough syrup. Unlike other advisory committee meetings, this meeting did not focus on a the treatment of a disease state, but rather on the treatment of a symptom.

On Sept. 11, 2017, the FDA’s Pediatric Advisory Committee voted 21 no, 2 yes, with one abstention, that the benefit versus the risk of opioid cough suppressants for pediatric patients was not favorable.

This vote was preceded by two previous votes specifically questioning the use of codeine and hydrocodone in medications for pediatric patients. For codeine, the committee voted unanimously with 24 against that the benefit versus risk was not favorable in pediatric patients aged 12 years to less than 18 years.

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For hydrocodone, the committee asked two questions: 1) Was the benefit versus risk favorable for pediatric patients aged 6 years to less than 12 years? and 2) Was the benefit versus risk favorable for pediatric patients aged 12 years to less than 18 years? On the vote for patients aged 6 years to less than 12 years, the committee voted 23 no, 1 yes with no abstention. For the patients aged 12 years to less than 18, the committee voted 23 no, 1 yes, with no abstention.

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Due to the wide scope of this committee, the voting was based on presentations from pharmaceutical company representatives presenting the results of industry-led studies and independent researchers.

According to Sharon Levy, MD, MPH, adolescents are the most at-risk population for opioid misuse. This susceptibility is due to the developmental neurobiology of adolescent brains. A region of the brain associated with the reward pathway, nucleus accumbens, is developing in adolescents and plays a role in salience. Salience, or the differentiation between important vs. unimportant rewards, varies widely by age group. Young children show little salience with rewards, and treat rewards equivocally. Adults have a proportional response to rewards with accurate salience. Adolescents, on the other hand, are unhappy with small rewards, but receive a massive return with large rewards. This type of neurobiological feedback makes adolescents “vulnerable to develop substance use disorders.”

Dr. Levy also noted a correlation between prescribed opioid use and alcohol, marijuana, and tobacco use as contributing factors to opioid misuse. When opioids are prescribed for pain management, there is an adjusted odds ratio (AOR) of 1.33, indicating a high likelihood of misuse. Similar AORs are seen in adolescents who have used marijuana, cigarettes, and alcohol: 2.44, 1.25, and 1.23, respectively.

Sovereign pharmaceuticals representative Leonard Lawrence presented the findings of a pharmacokinetic study for hydrocodone and guaifenesin in 25-35 pediatric patients evenly divided into groups aged 6 years to less than 12 years, and 12 years to less than 18 years. According to Mr. Lawrence, codeine appears “to be a greater risk in children younger than 12 years, and should not be used” because of difficulty breathing. Mr Lawrence went on to say that these effects were exacerbated in obese children with lung disease or obstructive sleep apnea.

Victor S. Sloan, MD, of UCB in Brussels, presented an internal review of Tussionex, a combination cough medicine (hydrocodone/chlorpheniramine). This review took into account modern pharmacovigilance methods, changes in clinical practice, and a literature review. “Upon annual review, UCB determined that benefit risk balance for use of Tussionex for cough in children was no longer favorable,” said Dr. Sloan. Based on the results of the review, UCB has filed a label supplement to limit use of Tussionex to patients aged 18 years or older.

“Codeine, in particular, is an antiquated drug,” said Kathleen Neville, MD, pediatrics and clinical pharmacology section chief of Arkansas Children’s Hospital, Little Rock. Many of the committee members echoed Dr. Neville’s opinion.

The committee members had no relevant financial disclosures.

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