Wednesday, 14 November, 2018

FDA attacked for OK'ing a painkiller stronger than morphine

FDA approves new opioid The FDA just approved an opioid painkiller 10 times more powerful than fentanyl
Ben Pena | 07 November, 2018, 22:31

Public Citizen described the drug as "five to 10 times more potent than fentanyl and 1,000 times more potent than morphine".

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.

Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis. However, despite the warnings, the opioid has been approved by the FDA for use in health-care.

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.

Sidney Wolfe of Public Citizen's Health Research Group, a consumer group, called Gottlieb's statement "empty rhetoric" and said the agency missed a big opportunity when it approved the pill. The opioid in question is a highly potent, and unsafe drug that has more risks than benefits in health-care.

Gottlieb has pledged that the FDA would do more to balance efforts to curb the epidemic-which killed a record 49,000 users in 2017, according to preliminary data-with the needs of people who need strong pain relief. It would not be available in retail pharmacies.

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According to the FDA's statement, the drug was designed for military use, and while no one wants soldiers to suffer, some may argue that in the war against opioid-related overdoses, there are plenty of battlefields right here at home-with more than 115 people dying after overdosing on opioids every single day in the United States.

The sublingual administration makes Dsuvia an option for patients with nothing by mouth (NPO) status and patients with hard IV access (obese, elderly, burn or needle-phobic patients), according to the statement.

The statement noted the benefit the drug could have for soldiers injured on the battlefield. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine.

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

In approving the drug, the agency skirted its normal vetting process, these critics say.

Leading the dissent was Raeford Brown, the chairman of an FDA advisory committee that reviewed AcelRx Pharmaceuticals' Dsuvia last month and ultimately recommended its approval in a 10-3 vote. Company executives said they expect to launch Dsuvia in the first quarter of 2019. On October 12-so, not that long ago-AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee.

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