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Members of Congress are protesting the FDA’s recent approval of the highly-addictive prescription painkiller Zohydro. Signed by seven other members of Congress, the open letter was sent to Health and Human Services Secretary Kathleen Sebelius on November 22, 2013.

Why all the hype?

Made by the company Zogenix, Zohydro is the first pure hydrocodone prescription drug to ever be approved by the FDA and the concerns for abuse cannot be ignored: Zohydro can be chewed, snorted, or injected by people wanting to abuse the drug such as opiate addicts in order to deliver a powerful dose of hydrocodone and to get a “high” that’s on-par with heroin. Pointing out the FDA advisory panel’s negative recommendation of Zohydro, the letter speaks to a fear of the seemingly certain likelihood for abuse.

Painkillers: A Public Health Risk

The Centers for Disease Control and Prevention (the CDC) reported that there were 38,329 drug overdose deaths nationwide in 2010 and that prescription drugs, such as painnkillers were involved in nearly 60% of those deaths. The report also details that, consistent with previous years, “opioid drugs, which include OxyContin and Vicodin, contributed to 3 out of 4 medication overdose deaths.”

Zohydro ER

From the Zogenix website:

“Zohydro ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.  Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions.

“Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”

What’s Really Going On?

The burning questions surrounding this are: why did the FDA approve such a dangerous narcotic in the first place and why did it ignore the negative recommendation of their own expert advisory panel?

Zohydro is the first hydrocodone-only opioid Zohydro, approved by an FDA panel vote of 11 to 2 in late October, and it is manufactured by the same company, Alkermes, that makes the popular medication Vivitrol, which is used to treat addiction to painkillers (like hydrocodone) and alcohol.

Alkermes also provides financial support to a powerful professional group of substance abuse experts, the American Society of Addiction Medicine.

One day before the approval of Zohydro, the FDA tightened rules on hydrocodone products, requiring the same Schedule II anti-abuse restrictions as oxycodone products. Unlike other narcotic painkiller drugs, Zohydro, will not have to adhere to the same protections, at least not yet; Zohydro received approval as-is, despite a recommendation against it by the FDA advisory panel.

Zogenix has said that an abuse-deterrent recipe for Zohydro is in early development but that it is “several years away from the market.”

How Zohydro Came to Be?

Zogenix started a clinical trial of Zohydro back in 2010 and it was approved using the controversial method known as enriched enrollment, which allows drug companies to basically weed out test patients who might not tolerate the drug from the trials so as not to skew the results.

The approach is cheaper than other methods and is criticized for being a way for drug companies to make a drug seem more effective, helping its chances of FDA approval. Some call it cheating, and that the method does not give an accurate representation of the drug’s effects once on the market for the masses.

If you or a loved one is struggling with narcotic substance abuse or addiction, please call toll-free 1-800-951-6135.



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