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What You Need to Know About Zohydro

After much controversy, the powerful painkiller known as Zohydro is scheduled to hit US markets this week.

The drug became the first pure hydrocodone medication to be approved by the US Food and Drug Administration (FDA) last October, but a coalition of 40 health care, consumer and addiction groups have urged for a last minute repeal. Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing, believes “it will kill people as soon as it’s released. It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule.”

Made by drug company Zogenix, Zohydro seeks to provide relief for those suffering from chronic pain conditions such as fibromyalgia and arthritis. It’s intended to only be prescribed to patients who don’t respond well to typical opioid medications. Zohydro will enter the market as a Schedule II drug, meaning it must be prescribed by a doctor for use.

“Concerns of Zohydro addiction were heightened further after it was announced the drug would be released in a crushable version, allowing it to be snorted or injected.”
However, the sole ingredient in Zohydro is hydrocodone, a highly addictive opioid. Concerns of Zohydro addiction were heightened further after it was announced the drug would be released in a crushable version, allowing it to be snorted or injected. Although the manufacturers of Zohydro announced plans to release a non-crushable version of the drug, it will take one to three years for it to hit the market. The FDA also did not require Zohydro to be released with an abuse-deterrent formulation, such as adding in niacin or naloxene, which creates unwanted side effects for those snorting or injecting it.

Many have also raised eyebrows that Zohydro will be manufactured by drug company Alkermes. The Irish company also produces a medication called Vivitrol, which treats people addicted to painkillers and alcohol. Dr. Stephen Anderson, a Washington emergency room physician, said that “[Zohydro is] somewhere in the neighborhood of five times more potent than what we’re dealing with now.”

The recent statistics for prescription pill addiction are truly disturbing. The 2010 National Survey on Drug Use and Health found 2.4 million Americans used prescription drugs non-medically for the first time within the previous 12 months. The Centers for Disease Control and Prevention also reported there were 38,329 drug overdose deaths nationwide in 2010 and that prescription drugs were involved in nearly 60 percent of those deaths. Prescription opioid deaths have also quadrupled since 1999, from 4,030 in 1999 to 16,651 in 2010.

There has also been a great deal of controversy surrounding the FDA’s approval of Zohydro. The drug was approved by the FDA despite the advisory committee they brought together voting against releasing it by 11-2. State Senators David Vitter (Republican, Louisiana) and Joe Manchino (Democrat, West Virginia) have since launched an investigation into an FDA official allegedly accepting thousands of dollars from pharmaceutical companies in order to obtain a seat on an FDA advisory panel meeting.

The senators claim these “pay-to-play” meetings gave drug companies “undue influence over FDA’s approval process for prescription painkillers.” A spokesman for the FDA denied all allegations of bribery and said Zohydro was only approved after careful consideration, believing the benefits didn’t outweigh potential drawbacks if the drug is used properly.

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