April 26, 2019
“As part of our work to explore innovative approaches to reduce exposure to opioids, we’re seeking public input on the safe prescribing of higher-strength opioids and the serious safety concerns associated with higher strengths and higher daily doses of opioid analgesics, both in patients and in others who may have access to these drugs. These products may be more harmful than other opioids in cases of accidental exposure and overdose and may also be more sought out for misuse and abuse,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “However, we also regularly hear from patients and health care professionals that higher-dose opioid analgesics are a crucial and necessary part of effective pain management for some patients. Through this public dialogue, our goal is to better understand what necessary steps we may need to take to ensure that only patients who truly need these medications gain access to them.”
The U.S. Food and Drug Administration announced today that the agency will be holding a public advisory committee meeting on June 11 and 12 to discuss safety concerns that have been raised concerning the safe prescribing and use of the higher-range doses of opioids. This is a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The agency is interested in learning more about how health care professionals are using these drugs in clinical practice and situations that may warrant the use of higher doses of opioid analgesics. The meeting will also discuss the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses – for example, a greater risk of overdose associated with a higher daily opioid dose – as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients.
The FDA meeting will include a discussion about:
- the specific clinical use of higher product strengths and daily doses and medical situations that may warrant pain management with these medications as well as factors influencing prescribing practices;
- identifying specific patient populations for whom there may be clear benefits in prescribing these medications at higher doses;
- the magnitude and frequency of harms associated with opioid analgesics at higher product strengths and daily doses, relative to lower strengths and daily doses, including the role of opioid dose in adverse health outcomes in both patients and in others who may access the drugs – such as those at risk of developing addiction or experiencing a fatal overdose;
- potential FDA actions that may address these issues, as well as the expected impact any such actions may have on patients and public health more broadly.
The FDA intends to make background material available to the public no later than two business days before the meeting.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.