In controversial terms, the United States Food and Drug Administration (FDA) is facing the completion of the approval of a…
In controversial terms, the United States Food and Drug Administration (FDA) is facing the completion of the approval of a highly addictive opioid. The decision was taken by the FDA Advisory Committee on October 12, where a 10-3 voice occurred in favor of the drug that hit the market.
“We are pleased with the recommendation of the advisory committee to approve DSUVIA as a treatment in medically supervised adult settings that experience moderate to severe acute pain,” said Dr. Pamela Palmer, founder and head teacher of AcelRx in a press release. “We are looking forward to Against continued cooperation with the FDA on the application because we consider DSUVIA to represent an important non-invasive emergency management option with the potential to significantly improve the current health standard. “
DSUVIA, the current drug, is a form of sufentanil-which is more potent than fentanyl and morphine, it would be sold as a subdental tablet. While it may treat pain, it is associated with a high risk of abuse and is addicted to it. Side effects include but are not limited to restlessness, muscle spasms, chest pain and fast heartbeat, according to PubMed Health.
Anaesthesiologist Raeford Brown at the University of Kentucky, who is also a committee chairman, wrote a letter on Thursday against the FDA’s approval. The letter was also signed by Sidney M. Wolfe, Meena M. Aladdin and Michael A. Carome of the Public Citizens Health Research Group.
“The agency believes there is a capacity so far not demonstrated to regulate this medicine so that it is used only in close collaboration controlled settings “, reads the letter.” In order for this to happen, training of all prescribers would need to be guaranteed. “ The letter continued: “This has not been demonstrated with any other opioid and given the lack of teeth in the current risk assessment and mitigation strategies for opioids, there is currently no training or regulation system that ensures that this drug will only be used as described on label. “
America is in the midst of an opioid crisis. According to the National Institute of Drug Abuse (NIDA), 21-29 percent of individuals who have an opioid prescription, misuse the drug. Of the 21 to 29 percent of people who abuse the drug,
President Donald Trump and his administration have noted the country’s opioid crisis, so he has declared that the problem is a public health problem.
“It’s time to free our communities from this drug abuse”, said Trump, 72, in October 2017 under a speech at the White House. “I control all agencies to use all appropriate emergency agencies to fight the opioid crisis.”