FDA approves powerful new pain pill despite fears of abuse

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The US Food and Drug Administration (FDA) is facing protests from several ends over a newly approved long-acting painkiller Zohydro. The health care advocates argue it is too dangerous to be available in the market as it has the capacity of 10 times more potent than Vicodin.

However, FDA contradicts saying it is a potentially important tool to help comforting those patients who are in chronic pain, usually at the end of life.

Mayhaven CEO Paul Coleman said there is nothing good about this drug and it will also complicate problems for the low enforcement, for providers of behavioral health care and for physicians too.

Zohydro contains hydrocodone that is found in Vicodin too, but it is a bit different as it is a potent extended-release formula and is not equipped with any acetaminophen, which is an active ingredient in Tylenol that is capable of causing liver damage and even death to a person taking high doses.

“There’s nothing more or less concerning about this than any of the other opioids we have to use. They all can be used for good when prescribed appropriately, and the opioids can be diverted and abused,” Dispatch.com quoted Charles von Gunten, who is OhioHealth’s vice president of medical affairs for hospice and palliative medicine.

However, the extended-release formula has taken the lead role in the controversy as protesters say the drug can be crushed and snorted. Earlier such extended-release painkillers too were abused like OxyContin, but now it is available in a crush-resistant formula.

Several addiction treatment groups are putting pressure on FDA to reverse the approval of Zohydro arguing the release of it this month could invite for addiction and deadly overdoses.

FDA approved Zohydro in 2013 even after the anti-vote of the advisory panel. Members of Congress, state attorneys general and others have asked the agency to rethink over the approval decision.

Source: http://www.thealmagest.com


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