New Pain Rx Sparking Controversy

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Zohydro ER opioid pain medication approval by FDA called dangerous by some

February 27, 2014 / Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

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(dailyRx News) A new pain medication recently became a controversial topic. While some say the medication will offer a new option to people in pain, others are concerned about potential dangers.

The medication, Zohydro ER, has been approved by the US Food and Drug Administration (FDA) to treat chronic pain in certain patients. However, some consumer groups are calling for reconsideration of its approval, citing concerns about addiction and the possibility for potential overdose.

"Discuss new prescriptions thoroughly with your doctor."

On February 26, an organization called the FED UP! Coalition released a letter to the FDA on behalf of over 40 different groups, including healthcare agencies, addiction treatment providers, consumer safety organizations and drug and alcohol prevention programs. The letter called for reconsideration of the FDA's approval of Zohydro ER (hydrocodone bitartrate extended-release capsules).

"The impending launch of Zohydro is causing some apprehension and concern within the medical and law enforcement communities," said E. Lee Carter, RPh, Clinical Pharmacy Specialist at the Department of Veterans Affairs in Prestonsburg, Kentucky.

"In many areas of the country, hydrocodone-containing products have become the largest source of prescription drug diversion and subsequent abuse. Zohydro will contain approximately five times the amount of other hydrocodone-containing products, and will be available as an easily crushed capsule. Unlike other similar pain medications, Zohydro will be available as a single-entity product, i.e., it will not contain any acetaminophen. Concerns have been expressed that if/when these extended-release capsules are diverted and abused, that the relative risk for serious adverse events (including drug overdose deaths) will be significantly increased, adding fuel to an already broadening epidemic of prescription opioid abuse," Carter told dailyRx News.

"Numerous organizations and physician’s groups have petitioned the FDA to revisit the approval and delay the launch of Zohydro pending further study and discussion. Several members of Congress have also expressed concern about the FDA approval, despite the agency’s own subcommittee voting 11-2 against its approval. In December, 29 states attorneys general sent a similar letter to the FDA asking the agency to review the recent approval of Zohydro," Carter said.

According to a statement from Public Citizen, a non-profit consumer watchdog organization and member of the coalition, while other prescription pain medications like Vicodin consist of an opioid called hydrocodone combined with acetaminophen, Zohydro ER is the first single-ingredient hydrocodone medication to be approved by the FDA.

"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 FED UP! Coalition wrote in its letter to the FDA.

Zohydro ER, which is set to become available in March, was approved in October by the FDA. In a statement at the time of this approval, FDA noted the risk of addiction and misuse inherent in opioids and said that the medication "should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain."

In a press release from Zogenix, the manufacturer of Zohydro ER, Zogenix Executive Vice President and Chief Medical Officer Bradley Galer, MD, said the medication will fill an important gap.

"As the first and only extended-release hydrocodone without acetaminophen, we expect Zohydro ER to fill a critical need for people suffering from chronic pain who are currently experiencing pain relief with around-the-clock immediate-release hydrocodone-acetaminophen combination products but are at risk for liver toxicity," said Dr. Galer. "Acetaminophen overdose is a leading cause of acute liver failure in the United States with almost two-thirds of those cases related to the use of these products."

The FED UP! Coalition disagreed, arguing in their letter that the new medication has the potential to be very dangerous.

"The highest available dosage of Zohydro will contain 5 to 10 times more hydrocodone than Vicodin or Lortab," the coalition wrote. "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."

Both the FDA and Zogenix cited Zohydro ER's clinical trials, in which over 1,100 chronic pain patients seemed to tolerate the medication well, and in which the medication showed improved pain management over a placebo.

Public Citizen reported that the FDA's own advisory committee voted 11 to 2 against the approval of Zohydro ER. The group urged the FDA to follow the advisory committee's recommendations and prevent the medication from reaching the market.

"The manufacturer of Zohydro, Zogenix, reports they will target a small and experienced group of providers with experience in treating chronic pain. Concerns have been expressed that in order to recoup research and development costs that the company will expand its marketing efforts, thereby increasing the number of prescriptions in circulation," Carter said. "In October, the FDA reported it intends to shift all hydrocodone-containing drugs from Schedule III to Schedule II status. That rescheduling (still pending approval by the Drug Enforcement Administration) would mean much stricter dispensing and prescribing guidelines for hydrocodone-containing products. Zohydro will be launched in the United States already in Schedule II status."

He added, "Patients with questions or concerns about Zyhydro or other pain medications should discuss them with their healthcare provider or pharmacist."