The crisis of opiate addiction in the United States did not prevent the country 's authorities from approving a new drug market called Dsuvia, 10 times stronger 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.
According to data from the Centers for Disease Control and Prevention (CDC of English), excessive use of opiates has caused a serious crisis in North American countries and over 115 people die every day from overdose. These include synthetic opiates such as analgesics, heroin, and fentanyl.
Opioid abuse not only brought about a health crisis, but also caused an economic crisis, according to the CDC, which caused $ 78.5 billion in annual medical costs, lost 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 mentioned why the FDA allows commercialization.
According to Gottlieb, Dsuvia is "the highest priority drug of the Department of Defense."
The US military was interested in this medicine because of its efficacy as well as its 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.
Professor Gottlieb said: "It is ideal for certain situations where the drug's unique character of being administered in a stable manner does not allow the patient to swallow oral medications and can not use intravenous analgesics.
"This includes possible uses on the battlefield," the commissioner explained, "the product will meet" unmet medical needs "and that the Department of Defense is working closely with Dsuvia's developers.
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 predict that in a few months after entering the market, they will find "use (use), abuse and death" in small format.
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.