A letter signed by more than 20 Democratic lawmakers, calling for black box labels to be put on immediate-release (IR) opioids, has been sent to acting FDA commissioner Stephen Ostroff.
Black box warnings indicate whether or not a drug carries a high risk of abuse.
Information from the Centers for Disease Control indicates that overdoses and deaths resulting from opioid abuse have increased significantly over the past decade.
Presently, the FDA mandates black box warnings on all extended release and long-acting opioid analgesics.
In their letter, the legislators pointed out that a recent review by the Agency for Health Research and Quality found no substantial proof that IR opioids presented less risk of abuse or misuse than long-acting opioids.
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