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The opiate addiction crisis in the United States is not it has prevented the authorities of this country from authorizing the entry of a new drug from this market. a type called Dsuvia ten times more powerful than fentanyl and a thousand times more powerful than morphine.
The Food and Drug Administration (FDA) gave its green light to Dsuvia last Friday, despite the fact that some Democratic senators and the chairman of the FDA's anesthetic and badgesic advisory committee Raeford Brown had asked him not to do it. [19659005] The excessive use of opiates has caused a serious crisis in this country of North America, where more than 115 people die each day from overdose according to data from Disease Control and Prevention (CDC). These include painkillers, heroin and synthetic opiates such as fentanyl.
The opioid abuse has not only caused a health crisis, but also an economic crisis, as they generate a "burden" of […] of US $ 78,500 million a year. on medical care, loss of productivity, drug treatment and court proceedings, according to the CDC.
FDA Commissioner Scott Gottlieb admitted in a statement Friday that opioid addiction is a priority for your institution. But he also indicated the reasons why the FDA authorized its marketing, being the main one among them its military application .
"Priority to the Pentagon"
Dsuvia is a "priority drug for the Pentagon", according to Gottlieb
The US military was interested in this drug, not only for its effectiveness, but also for its form of application .
It is composed of sufentanil, a substance that was previously administered intravenously or epidurally. But the novelty of Dsuvia is that it consists of a small pill that is placed under the tongue with a single-dose applicator.
"These unique features in which the drug is stably administered make it perfectly suited to certain special circumstances patients are not able to swallow oral medications and for which Access to intravenous badgesics is impossible "said Gottlieb.
"This includes possible uses in the battlefield", where this product will meet an "unmet medical need", allowing the Department of Defense to "work closely together" with the developers of Dsuvia, explained the commissioner.
Gottlieb admitted that in this case, "the military application of this new drug has been carefully considered" and that the needs of the military sector and the involvement of the defense in the creation They were part of the debate held by the FDA Advisory Committee, which decided on October 12 to approve the approval of this drug by 10 votes to 3.
Deviating Use
Raeford Brown, who is a professor of anesthesiology at the University of Kentucky and believes that sufentanil is an "extremely divertable" drug.
This was explained in a letter signed with experts from the Public Citizen lobby group in which she urged the FDA not to give Dsuvia the green light.
"It is a powerful opioid with significant risks of respiratory depression, deviation (in relation to use), abuse and death."
"It is so powerful that abusive users of its version intravenous often die by injecting the first dose, "a situation he claims to have witnessed.
The expert predicts that even in small formats, in the months following his entry into the market, "one will find detour (of its use), abuse and death ."
Gottlieb however recalled in his In addition, he stated that access to Dsuvia would be limited to "health environments under certified medical supervision", such as hospitals or centers.
He also said that the European Medicines Agency had also approved the same drug in July, although he called Dzuveo. It can only be administered by health professionals and never more than 72 hours.
Brown, however, baderted that the FDA "traditionally lacks the ability" to "apply controls" and that sublingual sufentanil "is a danger to public health in general."
"This will make our protection work Americans more difficult. "
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