Zohydro, a new, super potent opiate pain killer, received FDA approval on Oct. 25, 2014, in spite of significant concerns regarding its potential for abuse. Its maker, Zogenix (NASDAQ: ZGNX), a San Diego-based company, claims its new drug is a safer formulation of hydrocodone because it does not contain acetaminophen. Acetoaminophen is a common cause of overdoses and the leading cause of liver failure in the US. It is often included in hydrocodone-containing products. Nearly two out of every three acetaminophen overdoses are attributed to hydrocodone-acetaminophen products (Attorneys General Want FDA to Reconsider Zohydro).

Not only is acetaminophen, the active ingredient in Tylenol, the deadliest over-the-counter pain reliever on the U.S. market, but its dangers are being overlooked by members of the public and health officials, according to a new joint report by ProPublica and public radio program "This American Life."

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Acetaminophen overdose sends as many as 78,000 Americans to the emergency room annually and results in 33,000 hospitalizations a year, federal data shows. Acetaminophen is also the nation’s leading cause of acute liver failure, according to data from an ongoing study funded by the National Institutes for Health (Tylenol Overdose Risk Is Staggering; Acetaminophen Safeguards Remain Insufficient: Report).

Vicodin, which contains hydrocodone bitartrate and acetaminophen, is the most prescribed drug in the US. An opiate pain killer without acetaminophen could theoretically reduce the risks of overdose and death. But there's a darker side to Zehydro. The absence of acetominophen plus Zehydro's strength and formulation, which is not "abuse-deterrent," could lead to greater risks for abuse and death (Attorneys General Want FDA to Reconsider Zohydro). The presence of acetominophen in Vicodin presumably keeps at least some users from taking too much, although these users are not likely ones that crush or liquify the pills to snort or inject. 

An “abuse-deterrent” formulation means that additives are added such as naloxone or niacin to cause unwanted side effects when the drug is snorted or injected (Is The Super Potent New Opiate Painkiller Zohydro Just Too Dangerous?)

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

By Melanie Haiken

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.

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.” “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.

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.

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

Facts:

1. Opioid painkiller deaths quadrupled between 1999 to 2010. The number of U.S. drug poisoning deaths involving an opioid analgesic went from 4,030 to almost 17,000.

2. Prescriptions for painkillers have nearly tripled over the past 20 years.

3. Nearly 60% of drug overdoses are from FDA-approved prescription medications, not illegal drugs.

4. Three in four drug overdose deaths are due to opioid pain killers.

5. The US, with 5% of the world’s population, accounts for 84% of global oxycodone (Oxycontin) consumption and more than 99% of hydrocodone (Vicodin, Lortab) consumption. 

Read also: Attorneys General Want FDA to Reconsider Zohydro