A Kentucky doctor with expertise in the field is objecting to the Food and Drug Administration's plan to approve for sale a painkiller stronger than fentanyl, an opioid that is deadly even in very small doses.
Dr. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, is the longtime chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee. The panel voted 10-3 on Oct. 12 to support approval of a form of sufentanil branded as Dsuvia. Brown said he was unable to attend that meeting, but sent the panel a statement saying why sufentanil "represents a danger to the general public health and will make our job of protecting Americans more difficult." He explained the reasons for his opinion:
"Once the FDA approves an opioid compound, there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population relative to its benefit to the public health. Briefly stated, for all of the opioids that have been marketed in the last 10 years, there has not been sufficient demonstration of safety, nor has there been post-marketing assessment of who is taking the drug, how often prescribing is inappropriate, and whether there was ever a reason to risk the health of the general population by having one more opioid on the market."
Because sufentanil is so potent, it is given in "quite small" doses and easy to divert to illegal use, Brown warned. "I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market." Sufentanil is 500 times stronger than morphine.
The FDA says it can require the drug to be used only in "closely controlled settings," Brown wrote, but "In order to have this happen, the education of all prescribers would need to be guaranteed. This has not been demonstrated with any other opioid, and, given the lack of teeth in the current risk evaluation and mitigation strategies for opioids, there is currently no educational nor regulatory scheme that will guarantee that this drug will be used only as described in the label."
Brown's statement was part of a letter from the nonprofit public-interest group Public Citizen that criticized the FDA for not having its full Drug Safety and Risk Management Advisory Committee participate in the meeting of his committee, "predictably increasing the odds of a vote favoring FDA approval." The letter also said the FDA made "an unrealistic and dangerous decision . . . that the two major safety problems causing the agency to reject sublingual sufentanil tablets in 2017 were no longer a barrier to its approval and that the benefits thereby outweigh the risks."
Dsuvia’s manufacturer, AcelRx Pharmaceuticals Inc., says its 30-microgram tablets are no stronger than any other opioid already available in the U.S. It says the design makes it easier for use on a battlefield, "and could help elderly or obese patients, for whom an intravenous opioid can be difficult and oral opioids take some time to start working," Emma Court of Marketwatch reports.
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| Dr. Raeford Brown |
"Once the FDA approves an opioid compound, there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population relative to its benefit to the public health. Briefly stated, for all of the opioids that have been marketed in the last 10 years, there has not been sufficient demonstration of safety, nor has there been post-marketing assessment of who is taking the drug, how often prescribing is inappropriate, and whether there was ever a reason to risk the health of the general population by having one more opioid on the market."
Because sufentanil is so potent, it is given in "quite small" doses and easy to divert to illegal use, Brown warned. "I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market." Sufentanil is 500 times stronger than morphine.
The FDA says it can require the drug to be used only in "closely controlled settings," Brown wrote, but "In order to have this happen, the education of all prescribers would need to be guaranteed. This has not been demonstrated with any other opioid, and, given the lack of teeth in the current risk evaluation and mitigation strategies for opioids, there is currently no educational nor regulatory scheme that will guarantee that this drug will be used only as described in the label."
Brown's statement was part of a letter from the nonprofit public-interest group Public Citizen that criticized the FDA for not having its full Drug Safety and Risk Management Advisory Committee participate in the meeting of his committee, "predictably increasing the odds of a vote favoring FDA approval." The letter also said the FDA made "an unrealistic and dangerous decision . . . that the two major safety problems causing the agency to reject sublingual sufentanil tablets in 2017 were no longer a barrier to its approval and that the benefits thereby outweigh the risks."
Dsuvia’s manufacturer, AcelRx Pharmaceuticals Inc., says its 30-microgram tablets are no stronger than any other opioid already available in the U.S. It says the design makes it easier for use on a battlefield, "and could help elderly or obese patients, for whom an intravenous opioid can be difficult and oral opioids take some time to start working," Emma Court of Marketwatch reports.
from Kentucky Health News https://ift.tt/2CxVynf
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