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FDA wants stronger warning labels for long-acting opioids

Published on Apr 18, 2014 2:05 AM
 

(REUTERS) - The US Food and Drug Administration is requiring labels of all long-acting opioids to say they should be used strictly for patients in severe pain, a response to surging overdoses and deaths each year from the widely used pain medicines.

The health regulator in September proposed the label changes, saying they were needed to highlight dangers of abuse and possible death, as well as risks to newborns of mothers taking the medicines.

The FDA, in a notice on its website on Wednesday, said it had approved the proposed changes, which will indicate that such drugs should only be used for severe pain. Currently, the labels indicate they are appropriate for patients with moderate and severe pain.

Opioids include formulations of morphine, oxycodone, fentanyl and Oxycontin, a long-acting form of oxycodone. They currently are widely prescribed, including for patients that have had dental or surgical procedures, or those complaining of back pain or headaches. Extended-release opioids will also fall under the proposed FDA guidelines.

 
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