Type:Notice
Citation:89 FR 105613
Reading Time:about 22 minutes
The Food and Drug Administration (FDA) is recommending changes to how buprenorphine-containing products for opioid dependence are labeled. Currently, labels might be misunderstood as having maximum dosage limits, such as 16 mg or 24 mg per day, which isn't the case. These changes aim to clarify that higher doses can be prescribed if needed. Additionally, the FDA suggests adjusting labels to show that pregnant patients may require increased doses to ensure effective treatment.
Simple Explanation
The FDA wants to change the labels on some medicine that helps people with opioid problems because the current labels might make doctors think there's a strict limit on how much can be given, even though they can give more if needed, especially to pregnant women.