The crisis of opioid poisoning in the United States did not prevent the country's authorities from approving the market entry of this type of new drug called Dsuvia, 10 times more potent than fentanyl and 1,000 times stronger than drugs. morphine
Republican Senator Raeford Brown, who is chairman of the FDA's Drugs and Analgesics Committee, has been approved by the Democratic Senate and the Food and Drug Administration (FDA) on Friday for Dsuvia. I told him not to do it.
Excessive use of opiates has created a serious crisis in this North American country. Due to overdose, more than 115 people die every day. Among themAccording to data from the Centers for Disease Control and Prevention (CDC), these include synthetic opiates such as analgesics, heroin, and fentanyl.
Opioid abuse has caused not only a health crisis, but also an economic crisis. An annual $ 745 million "contribution" According to the CDC, in terms of medical care, loss of productivity, medication and judicial procedures
FDA Chairman Scott Gottlieb announced on Friday that drug addiction is a top priority for his agency. But he also expressed why the FDA allowed commercialization, Military support.
According to Gottlieb, Dsuvia is "the highest priority drug of the Department of Defense."
The US military is not only interested in this drug, but also because of its efficacy, application.
It is made up of sufentanil, a substance that has been administered intravenously or intramuscularly. But the quintessence of Dsuvia is that it consists of small pills that are placed under the tongue with a single spatula.
"This unique nature of the drug being administered in a stable manner makes it ideal for certain situations. Patients can not swallow. Oral medications and There is no access to intravenous analgesics."Gottlieb said.
"This includes possible uses on the battlefield." This product will meet "unmet medical needs". The Pentagon said it would "cooperate closely" Commissioner with Dsuvia developer explained.
Gottlieb acknowledged that "military application of the New Testament has been carefully considered," recognizing the military's need and defense intervention in the creation of Dsuvia as part of the Advisory Council's discussion. The FDA has decided to recommend that the drug be approved on Oct. 12 with 10 tablets, 3 tablets, and 3 tablets.
Use with Deviation
Raeford Brown, an anesthesiology professor at the University of Kentucky, believes "sufentanil is a" very potent drug. "
This was explained in a letter signed with experts from the Public Citizen pressure group urging the FDA not to disclose green lights to Dsuvia.
"It is a potent opioid with a risk of respiratory depression, drug addiction, abuse and death," he said.
"It is very powerful that people who abuse intravenous infusions often die by injecting their first dose," witnessed.
Experts say that in a few months after entering the market in small format, Deviation (from use), abuse and death"
Gottlieb recalled in his statement, however, that the name of Dzuveo, but the European Medicines Agency, also approved the same medicine in July.
In addition, access to Dsuvia will be limited to "sanitary environment with certified medical supervision" such as hospitals or emergency centers, administered exclusively by healthcare professionals and never exceeding 72 hours.
Dr. Brown said, however, that the FDA "does not have the ability to exercise control" historically, saying that "leprosy is a risk to the health of the general public."
"It will be harder to protect Americans," he said.
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