The buprenorphine-naloxone combination product (Suboxone) in sublingual tablet form will soon be pulled from the U.S. market because its child-resistant packaging isn't effective enough, its manufacturer said.
Citing "increasing concerns with pediatric exposure" to the tablet form, Reckitt Benckiser Pharmaceuticals announced that it would be discontinued in the United States over the next 6 months, or "possibly sooner depending on discussions with the FDA."
A sublingual film formulation with the same dosage of buprenorphine and naloxone, already approved and available in the U.S., will take the tablets' place, the company said.
Analysis of data from the U.S. Poison Control Center recently indicated that children had eaten tablets at "significantly higher rates" than the film formulation, according to Reckitt Benckiser.
"The rates for Suboxone Tablets were 7.8 to 8.5 times greater depending on the study period," the firm said.
Tablets are packaged in a 30-dose bottle with a child-resistant cap. The packaging does not appear to be defective, the company indicated; rather, patients may be leaving the cap off.
The sublingual film comes in individual packets that may be less tempting to an unsupervised child.
Patients currently taking the tablet form should talk to their physicians about transitioning to the film, Reckitt Benckiser said.
John Gever
Senior Editor
John Gever, Senior Editor, has covered biomedicine and medical technology for 30 years. He holds a B.S. from the University of Michigan and an M.S. from Boston University. Now based in Pittsburgh, he is the daily assignment editor for MedPage Today as well as general factotum on the reporting side. Go Pirates/Penguins/Steelers!
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