The tiny pill, “Dsuvia,” will be restricted to use only in health care settings such as hospitals. Critics worry it will fuel an already grim opioid epidemic.
A new opioid tablet that is 1,000 times more potent than morphine and 10 times stronger than fentanyl was approved by the Food and Drug Administration Friday as a fast-acting alternative to IV painkillers used in hospitals.
The painkiller Dsuvia will be restricted to limited use only in health care settings, such as hospitals, surgery centers and emergency rooms, but critics worry the opioid will fuel an already grim opioid epidemic.
Also on Friday, the Drug Enforcement Administration released a report showing that prescription drugs were responsible for the most overdose deaths of any illicit drugs since 2001.
Democratic Senator Ed Markey of Massachusetts urged the FDA not to approve Dsuvia last month, saying “an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill.”
To that, FDA Commissioner Scott Gottlieb said in a statement that “very tight restrictions” will be placed on Dsuvia.
Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said. The medication, which comes in a single-use package, also should not be used for more than 72 hours. The medicine comes in a tablet that can dissolve under the tongue. Side effects of the potent drug include extreme tiredness, breathing problems, coma and death.
Gottlieb said military use of the drug was “carefully considered in this case” as the FDA wants to “make sure our soldiers have access to treatments that meet the unique needs of the battlefield.”
The Associated Press contributed to this article. Follow Ashley May on Twitter: @AshleyMayTweets
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