Is The Super Potent New Opiate Painkiller Zohydro Just Too Dangerous?

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A new opiate painkiller with 5 to 10 times the power of Vicodin, set to hit the market in March, could trigger a disastrous spike in overdoses and deaths, says a powerful coalition of doctors, lawmakers, and addiction specialists.

In a strongly worded letter that could be titled “Just Say No to Zohydro” 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 potential to add to the growing epidemic of painkiller addiction.

“In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” the experts 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 easy-to-crush capsule. It will kill people as soon as it’s released.”

This isn’t the first group of experts 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 someone new to opioids could die of an overdose from just two pills, the experts say. And a child could die from ingesting just one capsule. According to the FDA’s review, the relief – or the high – of Zohydro can last up to 12 hours per dose.

An ad for Zohydro ER, which experts say is too dangerous and should not have received FDA approval.

The CDC’s data on opioid painkiller deaths speaks for itself, showing that deaths quadrupled in a ten year period. Between 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 those from heroin and cocaine combined. CDC data show that prescriptions for painkillers have nearly tripled over the past two decades, and 5 million Americans are dependent on the painkillers.

There’s no disagreement that we’re in the middle of an epidemic of painkiller abuse. Since 1999, the U.S. has seen deaths from opiate painkillers jump by 415 percent in women and 265 percent in men. And this isn’t just black-market drugs – the biggest victims are middle-aged men and women legitimately prescribed the drugs for chronic pain, the experts say. Nearly 60 percent of all drug overdoses are from FDA-approved prescription medications, not illegal drugs. According to Forbes’ own Robert Pearl, MD, 3 in 4 drug overdose deaths are due to an opioid painkiller such as oxycodone, hydrocodone or methadone.

The question, experts say, is do we need a new opiate painkiller at all, given that we seem unable to prevent the ones we already have from ending up in the wrong hands? A drug this strong has enormous potential for abuse, and the U.S. does not have a good track record in preventing that from happening. The death of Philip Seymore Hoffman put a spotlight on the potential of oxycodone, Vicodin, and other painkillers to set people up for heroin addiction, which has also been on a rapid rise in the U.S. over the past few years.

The U.S., with just 5 percent of the world’s population, now accounts for 84 percent of global oxycodone (Oxycontin) consumption and more than 99 percent of hydrocodone (Vicodin, Lortab) consumption. That’s a lot of painkillers.

Zohydro ER was approved by the FDA on October 25, 2013. Pharmaceutical experts have expressed surprise that  Zohydro was approved without an “abuse-deterrent” formulation, which means a formulation including additives like naloxone or niacin that cause unwanted side effects when the drug is snorted or injected but are tolerable when taken orally as prescribed.

The primary thing that sets Zohydro apart – other than its strength – is that it doesn’t contain acetaminophen, as Vicodin does, and it’s on this basis that its maker, Zogenix, has argued that it’s safer than the alternatives. That’s simply not true, argue its opponents, who point out that there are plenty of other opiate painkillers already on the market that don’t contain acetaminophen. Zohydro is expected to be available as early as March.

In addition to Kolodny, the coalition, which calls itself Fed Up, unites doctors, pharmaceutical industry experts, advocacy groups, and addiction specialists, including G. Caleb Alexander, MD, Co-director of the Johns Hopkins Center for Drug Safety and Effectiveness; Stuart Gitlow, MD, President of the American Society of Addiction Medicine; Daniel Busch, MD, of the Feinberg School of Medicine at Northwestern University.

In response to previously expressed concerns, Zogenix has established a safe-use board of experts outside the company to aid in overseeing “appropriate use” of the drug.

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