WASHINGTON – The Food and Drug Administration Friday approved a new form of severe pain & # 39; opioid & # 39; to manage severe pain in adults, a week after the board reviewed the proposal asked Hold & # 39; agency to refuse due to the looga likely to be abused.
Drugs, Dsuvia, is a form of tablet sufentanil, a synthetic opioid used roots and epidurals since the 1980s. It is 10 times stronger than fentanyl, which is a drug used mainly for hospitals, but also illegally produced in the form of tens of thousands of deaths in recent years.
Although F.D.A. The Advisory Committee charged with evaluating the new system finally recommended that the 10-3 vote last month to hold & # 39; addu approval, the board chairman, Dr. Raeford Brown, wrote to F.D.A. officials after revealing deep concerns.
The letter, written by the Citizens' Citizens Advocacy Team, Dr. Brown, an astrophysicist at Kentucky University, describes Dsuvia, made by AcrRx Pharmaceuticals, "very diverse drug," predicts that we will experience triage, abuse and death in the early months of the marketing market. "
Following the adoption of Friday's final decision, Dr. Scott Gottlieb, F.D.A. chairman, released for a long time Deformation Statement Going & # 39; He emphasized that Dsuvia is being "pre-filled, one-on-one," and said the only acceptable use would be in hospitals, surgical centers and other health facilities. It is suited to specific circumstances, he said, especially the injured soldiers who flipped on the battlefield that may not be able to get the pain relief.
Dr. Gottlieb writes that Dsuvia will not be given patients who are used to their home or are available at retail stores, and that they should only administer health care providers with one-on-one vaccinations. It is likely to hit the market early next year.
"Measures to limit the use of only one item at a supervised medical care, and I used to use at home, are important steps in looga prevent misuse and abuse," he wrote.
He also pointed out that the new capacities in the field need to be studied in the later market after evaluating the effectiveness of opioids in F.D.A. he may have other thoughts on it, and consider the risk of rape as a matter of concern about the issue after the drug, as well as before, in the market. Last year, F.D.A. asked abukaataha Opana ER, a bold and strong opioid, to make looga market because of concern about the violation.
Vince Angotti, executive director of AceRx, said the company will carefully follow a program of safety, known as the risk assessment and reduction strategy, that F.D.A. was allowed to Dsuvia, including drug distribution and exercise information; evaluation if hospitals and other health care providers use proper medications; and monitoring any defamation or abuse.
Components against approval of a new drug comes back compared to opioid Overcrowded deaths have risen more than 40,000 last year, including more than 30,000 from fentanyl and opioids. Governments and governments have cracked down on opioids, and many patients with chronic diseases have resorted to losing or losing access to opioids completely.
Dr. Brown, chair of the consultative committee for natural remedies and anesthetics, was not present at the electoral commission last month. But after a letter, he stressed that the attempts to restore the doctors, health students and other healthcare providers – "a lot of success" – were more than the function of the IV clinic where he worked
"It's very, very serious, that violates the system's tightly-contaminated system, often dying when they first injected it," wrote.
Dr. Brown also came from F.D.A. it would have been successful in enforcing laws once dangerous drugs hit the market.
"It indhahaygeyga when he approved the construction of opioid F.D.A.," he wrote, "there is no protection of the public out, after marketing analysis of the nature of recruitment, or the analysis of the dangers of drugs to the general public."
Tribal problems include four members of the Democratic Party – Edward Markey from Massachusetts, Richard Blumenthal of Connecticut, Missouri in Missouri and Joe Manchin in West Virginia.
Letter to Dr. Gottlieb on Tuesday, asked why the Draft Committee Brown opposed and approved the treaty on October 12 without him. They also asked why F.D.A. the advisory group, the Safety and Security Advisory Committee and the Risk Security, were not involved.
An F.D.A. The spokesperson said that despite the fact that the matter was not formally introduced to the subcommittee on drug security, "there were experts and risk experts in the committee whose expert advice was taken seriously during this process."