A new opiate painkiller with five to 10 instances the energy of Vicodin, set to hit the marketplace in March, could trigger a disastrous spike in overdoses and deaths, says a effective coalition of doctors, lawmakers, and addiction specialists.
In a strongly worded letter that could be titled “Just Say No to Zohydro” far more than 40 experts urged the Food and Drug Administration (FDA) to reconsider its approval of Zohydro ER, a potent extended release formulation of straight-up hydrocodone, citing its prospective to include to the increasing epidemic of painkiller addiction.
“In the midst of a significant drug addiction epidemic fueled by overprescribing of opioids, the really final thing the nation needs is a new, dangerous, substantial-dose opioid,” the authorities wrote, addressing FDA Commissioner Margaret A. Hamburg, MD.
One member of the letter-writing coalition, Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing, was more blunt: “It’s a whopping dose of hydrocodone packed in an straightforward-to-crush capsule. It will kill men and women as quickly as it is released.”
This isn’t the very first group of professionals to beg the FDA to reconsider. A coalition of Congressional representatives and state Attorney Generals has also urged the FDA to listen to its own advisory panel, which voted 11 to 2 against approving Zohydro.
What’s all the fuss about? Plenty. Zohydro is so strong that an individual new to opioids could die of an overdose from just two pills, the professionals say. And a little one could die from ingesting just 1 capsule. In accordance to the FDA’s evaluation, the relief – or the substantial – of Zohydro can last up to 12 hrs per dose.
An ad for Zohydro ER, which professionals say is as well dangerous and ought to not have obtained FDA approval.
The CDC’s data on opioid painkiller deaths speaks for itself, exhibiting that deaths quadrupled in a 10 12 months period. Among 1999 to 2010, the number of U.S. drug poisoning deaths involving an opioid analgesic went from 4,030 to almost 17,000, now topping people from heroin and cocaine mixed. CDC data display that prescriptions for painkillers have nearly tripled above the previous two decades, and 5 million Americans are dependent on the painkillers.
There is no disagreement that we’re in the middle of an epidemic of painkiller abuse. Given that 1999, the U.S. has seen deaths from opiate painkillers jump by 415 percent in ladies and 265 percent in men. And this isn’t just black-marketplace drugs – the biggest victims are middle-aged men and women legitimately prescribed the medication for persistent pain, the experts say. Nearly 60 percent of all drug overdoses are from FDA-accredited prescription drugs, not illegal drugs. In accordance to Forbes’ personal Robert Pearl, MD, three in four drug overdose deaths are due to an opioid painkiller such as oxycodone, hydrocodone or methadone.
The question, professionals say, is do we want a new opiate painkiller at all, given that we seem to be unable to avoid the ones we already have from ending up in the wrong hands? A drug this sturdy has huge likely for abuse, and the U.S. does not have a good track record in avoiding that from taking place. The death of Philip Seymore Hoffman put a spotlight on the possible of oxycodone, Vicodin, and other painkillers to set folks up for heroin addiction, which has also been on a quick rise in the U.S. above the previous number of many years.
The U.S., with just 5 percent of the world’s population, now accounts for 84 percent of global oxycodone (Oxycontin) consumption and a lot more than 99 % of hydrocodone (Vicodin, Lortab) consumption. That is a great deal of painkillers.
Zohydro ER was authorized by the FDA on October 25, 2013. Pharmaceutical professionals have expressed shock that Zohydro was accredited with no an “abuse-deterrent” formulation, which implies a formulation like additives like naloxone or niacin that cause undesirable side effects when the drug is snorted or injected but are tolerable when taken orally as prescribed.
The primary issue that sets Zohydro apart – other than its strength – is that it doesn’t contain acetaminophen, as Vicodin does, and it is on this basis that its maker, Zogenix, has argued that it is safer than the options. That’s simply not true, argue its opponents, who stage out that there are lots of other opiate painkillers already on the industry that don’t include acetaminophen. Zohydro is anticipated to be accessible as early as March.
In addition to Kolodny, the coalition, which calls itself Fed Up, unites medical professionals, pharmaceutical business professionals, advocacy groups, and addiction professionals, including G. Caleb Alexander, MD, Co-director of the Johns Hopkins Center for Drug Security and Effectiveness Stuart Gitlow, MD, President of the American Society of Addiction Medication Daniel Busch, MD, of the Feinberg College of Medication at Northwestern University.
In response to previously expressed concerns, Zogenix has established a secure-use board of specialists outdoors the company to help in overseeing “appropriate use” of the drug.
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Is Zohydro, The Super Potent New Opiate Painkiller, Just Too Unsafe?
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