The US Food and Drug Administration (FDA) is asking manufacturers to update labeling for transmucosal buprenorphine products to allow for higher doses, addressing the growing need for stronger treatment options against high-potency opioids like fentanyl. The current labeling, misinterpreted by some clinicians and payers, restricts dosages, potentially hindering effective treatment.
The US Food and Drug Administration is urging manufacturers to revise labeling of transmucosal buprenorphine products to ease access to higher doses needed due to the rise of high-potency opioids like fentanyl.in the Federal Register in late December. The move comes on the heels of increasing evidence that some clinicians, and many payers, are taking the current labeling too literally, and either not giving patients enough of the medications or denying payment for higher doses.
“This is an important step forward because it’s recognizing that the drug supply has changed,” said Melissa Weimer, MD, associate professor of medicine and public health at Yale School of Medicine, New Haven, Connecticut.
Weimer said the use of higher-dose buprenorphine has evolved quickly. As her practice began seeing more people using fentanyl, starting in 2019, higher doses of buprenorphine were needed to stabilize them “and to reduce their return to opioid use.” Most need 24 mg daily, and “some individuals were needing even higher doses,” Weimer noted.document to help guide clinicians treating individuals who use high-potency opioids like fentanyl.
Many states have restrictions on buprenorphine prescribing, such as mandated counseling and drug testing for recipients, according to Vital Strategies. Some research indicates that mandated counseling may inhibit access to treatment access, but 14 states and the District of Columbia require counseling for some or all buprenorphine patients, the
Buprenorphine Fentanyl Opioid Crisis FDA Labeling
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