FDA criticized for approving new painkiller 1,000 times stronger than morphine: 'You have blood on your hands'
The Food and Drug Administration (FDA) is getting the side-eye after approving a painkiller that’s said to be 1,000 times stronger than morphine. Critics point out that this comes amid an opioid epidemic in the United States — which led to more than 72,000 deaths in 2017 alone.
The drug is called Dsuvia, and FDA commissioner Scott Gottlieb, MD, addressed the timing in a statement released late last week. “The crisis of opioid addiction is an issue of great concern for our nation,” he said. “Addressing it is a public health priority for the FDA. The agency is taking new steps to more actively confront this crisis while also paying careful attention to the needs of patients and physicians managing pain.”
Gottlieb also made the case for Dsuvia’s approval on Twitter, and reactions weren’t positive:
You have blood on your hands
— TheResistance Report (@AntiTrumpReport) November 2, 2018
You should resign.
— Charles Harris (@ChuckVapes) November 2, 2018
When there’s some healthcare provider out there who OD’s on this stuff for the first time, you can unequivocally tell yourself you killed them personally. Crazy how OD’s work. One bad dose is all it takes for that person to never have an opportunity at sobriety again.
— Patrick (@patrick2278t) November 3, 2018
Why would you do this?
— Renee Rocks (@bluerockrz) November 4, 2018
Dsuvia is a sublingual (meaning it is taken under the tongue) form of sufentanil (a synthetic opioid) that’s delivered through a disposable, pre-filled, single-dose applicator, the FDA says. It is restricted to being used in certified medically supervised health care settings like hospitals, surgical centers, and emergency departments.
Gottlieb also points out in his statement that it can help in special circumstances in which a patient may not be able to swallow, adding that there could be potential uses on the battlefield. There are also “very tight restrictions being placed on the distribution and use of this product,” Gottlieb says.
The medication won’t be available at pharmacies and shouldn’t be used for more than 72 hours.
“This has actually been on the market as an injectable for quite some time,” Jamie Alan, PhD, an assistant professor of pharmacology and toxicology at Michigan State University, tells Yahoo Lifestyle. “It’s not a new drug; It’s a new dosage.” Alan says the concern around the drug is “valid given the potential for abuse.” However, she adds, the safeguards that the FDA has put in place should help.
Dsuvia “works exactly the same as morphine and other opioids do,” Alan says. Meaning, it binds to opioid receptors in your body to help reduce or block pain. “This drug just will work a lot more than morphine — it’s 1,000 times stronger,” she says.
The serious potential side effects are the same as with morphine, Alan says, including decreased respiration, trouble breathing, coma, and death. “It doesn’t tend to cause itching or blood pressure issues like morphine, but the concerning side effects are still there,” she says.
Dsuvia isn’t designed to be taken by people who haven’t taken morphine in the past, Alan says. Rather, it’s for patients who have “used opioids before and probably have some sort of tolerance to opioids,” she says. It’s also designed to be used in “really specialized situations” including end-of-life care and pain that isn’t helped by other opioids, Alan says. “This is certainly not first- or second-line pain medication,” she says. “It shouldn’t be given to Joe Shmoe coming in with a broken arm.”
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