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Coming soon to the U.S market is a highly potent prescription painkiller that is designed to treat people with moderate to severe chronic pain. Zohydro, is an extended release form of hydrocodone, the same ingredient in Vicodin.

Zohydro releases small doses of hydrocodone around the clock. In October, the FDA went against the recommendation of its own advisory committee and approved the highly addictive painkiller, making Zohydro the first hydrocodone-only drug that doesn’t contain some form of Acetaminophen, Ibuprofen, or codeine. Make no mistake about its name, Zohydro is just powerful as it sounds. In fact, Zohydro is up to 5 times as strong as its predecessor, Oxycontin, and is 10 times more potent than Vicodin. Zohydro retains its potency when crushed and can be snorted or injected, making it an easy target for abuse. The question is, can a drug this powerful and concentrated be used as approved?

How Did the Drug Get Approved?

The logistics of this question remain a mystery. Especially because early in 2013, an FDA panel voted 11 to 2 against the approval of the powerful new painkiller. In a petition to the U.S. Food and Drug Administration, anti-addiction groups call the drug “the next Oxycontin” and they are warning if it is released to pharmacies as scheduled, it will lead to more addiction and drug-related deaths. The experts of these anti-addiction groups also plea “In the midst of a severe drug addiction epidemic fueled by over prescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid.” In defense of the backlash, FDA commissioner Margaret A Hamburg pleaded her case by saying “So many patients need it and the product benefits outweigh the risk when used as approved.”

However, doctors say that this drug is so powerful that it’s fatal even if taken as prescribed. Dr. Andrew Kolodny, the Chief Medical Officer at Phoenix House believes that people will die as soon as it’s released. He says “Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child.” Statistics show that The U.S, with just 5 percent of the world’s population, now account for 84 percent of global oxycodone consumption and more than 99 percent of hydrocodone (Vicodin, Lortab) consumption. So the question remains, if abuse of these types of drugs are now the number one cause of preventable death in America, then why and more importantly how did the FDA approve a more lethal drug with more Oxycodone?

Zogenix, the maker of the drug wrote in their release statement “Zohydro is a new treatment option that is essential for patients who suffer from non-stop pain like cancer, back pain, and arthritis.” They went on to say Zohydro would be safer than hydrocodone/acetaminophen pills because acetaminophen is “known to cause significant liver toxicity when taken in large doses over time.” These statements carry no validity because Zohydro “in large doses over time” will kill people rather than leave them with liver problems.

Also there are plenty of other opiate painkillers already on the market that don’t contain acetaminophen and are very deadly. The point is, the risk of releasing this drug heavily outweighs the reward. Why the FDA and Zogenix ignore the facts is simply ludicrous.

Is there anything that can be done?

The drug will be released very soon, thus there isn’t anything that can be done to stop it from flooding the streets. Fortunately, the drug can be banned once it’s released. As farfetched as this may sound, the company that manufactures Zohydro also manufactures a drug called Vivitrol that is used to treat opiate addiction. Hopefully the FDA is able to quickly ban the drug or at the very least put stringent protocols in place regarding the dispensing of this medication reducing the amount of harm it will inevitably cause to those who obtain it either legally or illegally.

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