Dsuvia's FDA approval means that there is now another opioid on the market – an extremely strong one. It is 1,000 times more effective than morphine and 10 times more potent than fentanyl. Many people have expressed concerns that this drug may aggravate the opioid crisis. You ask yourself: "Do we really need that on the market?". As with most medical advances, there are pros and cons.
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The drug is a sublingual (under the tongue) version of sufentanyl, first produced in 1
What are the disadvantages? Well, a drug that is so powerful that it can be taken by mouth can be abused. Synthetic opioids such as fentanyl are for many a "high". Just because the drug is a thousand times more effective does not mean that the "high" is a thousand times stronger: it just means that the dose required to achieve the effect is much lower.
The FDA has taken some steps to reduce the likelihood of abuse: the drug is being delivered in a disposable disposable container and is not available for home or home use retail pharmacies, only in "medically supervised" facilities such as hospitals or military. The FDA has also mandated that Dsuvia be "reserved for patients with alternative pain." Treatment options have not been tolerated or are expected to be tolerated if existing treatment options have not provided adequate analgesia, or if these alternatives are expected to fail to provide adequate analgesia. She will also include a "black box" warning warning the highest possible FDA questions to indicate that there are serious risks associated with the drug. None of these procedures guarantees that the drug will not be abused, the people as they are, but it reduces the likelihood of abuse and distraction.
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Although the US continues to have a serious opioid problem, I do not think Dsuvia's approval is likely to escalate given its precautions. While its applications in the emergency room and operating room are marginal, it is not a thousand or even ten times more dangerous than fentanyl that is synthesized and sold illegally on the street. In certain situations that are worthy of inclusion in the Medical Toolkit, there are unique benefits and, in my opinion, these outweigh the risks in this case.
Dr. Keith W. Roach, FACP, is Associate Professor of Medicine at Weill Cornell