FDA approves pure hydrocodone painkiller Zohydro ER against advice of expert panel

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by Eric Pearson

As we reported in a previous article, the Food and Drug Administration made front page headlines in October by announcing that it would recommend moving drugs like Vicodin, which combine hydrocodone with over-the-counter painkillers, to the restrictive Schedule II class of drugs. The purpose of such a move is to make it harder for people to access the drugs involved. However, at basically the same time the FDA was deciding to impose new restrictions on those drugs, the FDA surprisingly also approved a new opioid analgesic called Zohydro ER, despite a recommendation against the drug’s approval by the FDA’s own advisory committee.

Hydrocodone, when combined with ingredients like acetaminophen or aspirin, is the most commonly prescribed painkiller in the country. It also is a highly addictive opioid and can be extremely dangerous. From 1999 to 2010, the number of deaths involving opioid analgesics including hydrocodone more than quadrupled, to nearly seventeen thousand.

Opioids have been shown to help with certain kinds of pain such as, short-term pain from an operation or from cancer. However, there continue to be questions about whether the drugs are appropriate for chronic, long-term conditions.

The recently-approved drug, Zohydro ER is an extended-release painkiller that, unlike Vicodin and similar drugs, does not include acetaminophen or aspirin. Instead, Zohydro ER is made of pure hydrocodone and uses a higher dosage scale than hydrocodone-combination drugs like Vicodin. Zohydro ER is every bit as potent and addictive as other opioids and will come in capsules, a form particularly prone to abuse. Furthermore, there is no abuse-deterrent version of the drug. In other words, there is no version of Zohydro ER meant to keep people from crushing or chewing the drug.

The FDA’s advisory board, an appointed group of medical experts who evaluate drugs used in anesthesiology and surgery, voted against Zohydro 11-2 last December. As several board members noted, most opioid painkillers on the market also include acetaminophen, the main ingredient in Tylenol, a combination that is less likely to lead to addiction. On the other hand, Zohydro ER, like OxyContin, a drug the DEA has blamed for hundreds of deaths per year, includes a high dose of its main opioid ingredient undiluted by acetaminophen. The FDA advisory committee recommended the agency refuse to approve Zohydro ER’s new drug application because of concerns about the risk of misuse and abuse and the resulting potential impact on public health.

Deciding to approve Zohydro ER despite its advisory committee’s recommendation, the FDA said “that the benefits of this product outweigh the risks” and that hydrocodone has “abuse liability similar to other drugs [in] its class.” This conclusion ignores the fact that Zohydro has 5 to 10 times more of the heroin-like opioid hydrocodone than, for example, Vicodin. The Centers for Disease Control and Prevention has released data showing that painkillers are essentially the worst drug epidemic in US history, killing 16,000 people in 2010 alone.

Heygood, Orr & Pearson fights for painkiller overdose victims

If you or a loved one has been the victim of complications from an opioid overdose, the doctor or hospital who prescribed these drugs may be to blame. Many doctors who prescribe strong painkillers to their patients have little experience with pain management, causing them to prescribe drugs that are too powerful or in doses that exceed what a patient requires. Sadly, many of these mistakes end in addictions, overdoses, or deaths that could have been prevented.

The lawyers at Heygood, Orr & Pearson are among the nation’s leaders in handling cases involving potent opioids, and our law firm has the experience to prosecute medical malpractice cases involving a wide array of serious opioid painkillers, including Vicodin, hydrocodone, OxyContin, oxycodone, methadone, hydromorphone, fentanyl, and others.

For more information about opioid painkiller lawsuits and to find out if you are eligible to file a case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001, or by filling out the free case evaluation form located at the top of this page.