Following a recent review of Tussionex^® (hydrocodone polistirex and chlorpheniramine polistirex) – a cough syrup containing hydrocodone and chlorpheniramine– we determined the benefit-risk balance for the use of Tussionex^® to treat cough associated with cold or allergy in children was no longer favorable. Because of this, UCB proactively approached the U.S. Food and Drug Administration (FDA) to request that Tussionex^® be limited to use in adults.

At UCB, we are committed to delivering patient value and reaching the right patients at the right time with our products. With this goal in mind, our specialized teams review the benefit-risk of all UCB products on a regular basis, including older products that may have been approved in different regulatory eras. Each product’s team presents to the UCB-wide global Benefit Risk Board (BRB), which has overall responsibility to regularly assess each product, encourage healthy debate, and take courageous decisions to create value for patients.

A recent assessment, by the BRB, of Tussionex® – a cough syrup containing hydrocodone and chlorpheniramine approved by the U.S. Food and Drug Administration (FDA) in 1987— determined the benefit-risk balance for the use of Tussionex to treat cough associated with cold or allergy in children was no longer favorable. This conclusion was based on careful review using modern pharmacovigilance methods including consideration of the changes in clinical practice and a review of literature considering up to date standards.

Accordingly, UCB proactively requested, in a supplement submitted in January 2017, for Tussionex® to be limited in use to patients age 18 or older. Before changing the product label, the FDA decided to bring this topic to their Pediatric Advisory Committee for review. UCB was invited to present, highlight our commitment to patient value, and proactively discuss with the committee regarding the removal of pediatric indication for Tussionex®, based on updated pharmacovigilance standards regarding the use of codeine or hydrocodone-containing syrup for cough in children.  In their introduction, the FDA singled out UCB for proactively addressing the benefit risk in children.

The Advisory Committee was clear in their opinion that these products should not be used to treat cough associated with cold or allergy in children. UCB is pleased the FDA has approved changes to the label for Tussionex® (hydrocodone polistirex and chlorpheniramine polistirex), restricting use to patients age 18 and older.  In addition, the FDA went further, imposing class labeling on all cough medications containing opioids limiting their use in children under 18, and in adults to only those patients in whom the suppression of the cough clearly outweighs the risk.  We strongly believe this is the right decision for patients.