FDA attacked for OK'ing a painkiller stronger than morphine

FDA attacked for OK'ing a painkiller stronger than morphine

Despite the ongoing opioid crisis plaguing the nation, the US Food and Drug Administration on Friday approved a new opioid medication five to 10 times more powerful than fentanyl.

Democratic Senator Ed Markey of MA 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". "We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval - the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", he said.

The FDA announced its approval November 2 of a new prescription opioid called Dsuvia, despite public and medical criticism for the drug's approval in the midst of the opioid epidemic, according to STAT. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

FDA Commissioner Scott Gottlieb announced approval of AcelRx Pharmaceuticals' painkiller Dsuvia Friday, an announcement that largely went under the public's radar, except for a swift denouncement by U.S. Sen. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts.

But those restrictions are not sufficient, claims Senator Ed Markey (D-MA), who blasted the FDA for failing to prove that the drug has enough "unique benefits over other available FDA-approved opioid products" to justify the risk of abuse.

The statement noted the benefit the drug could have for soldiers injured on the battlefield. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.

Health experts said the pill isn't needed and will only worsen the opioid epidemic.

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"I am very disappointed with the decision of the agency to approve Dsuvia".

The medication should not be used for more than 72 hours at a time, according to the FDA.

The new, single-dose tablet version of the pain killer, mean to be taken under the tongue, can only be given in hospitals and is meant for those who can't take an IV.

Critics and public officials alike have commented on how the FDA should change its approach when evaluating opioid applications.

More: Drugs kill more Americans than guns, cars and AIDS.

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says.

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