When Zohydro is released for sale in March, it will be one of the most powerful prescription painkillers on the market today. In its highest dosage, it will contain 5 to 10 times as much hydrocodone as Vicodin, a widely prescribed pain medication.
More than 42 health groups, including physicians, university researchers and drug rehabilitation specialists, are putting pressure on the Food and Drug Administration (FDA) to revoke approval of the prescription pain medication, Zohydro, given last year.
The drug is similar to Oxycontin, only more powerful, and was approved by the FDA last year, despite its own advisory council voting against approval in December 2012. At that time, the advisory panel cited the increased possibility of the drug being abused.
In a letter to FDA Commissioner Dr. Margaret Hamburg. the coalition of groups wrote, "In the midst of a severe drug epidemic fueled by over prescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid." The group cited the number of people in the U.S. who have become addicted to opioids, as well as the number of deaths.
This is not the first letter against the FDA's allowing Zohydro to be released next month. In December, 29 state attorney's general sent a similar letter to the FDA. And in October of 2013, members of Congress were urged to ask the FDA to review its decision on Zohydro. All the groups opposing the release of the painkiller share the same fears.
Concerns voiced by many include the potency of the pain medication, its abuse potential, especially in higher doses, and the danger it poses to the uninformed. According to officials at Zogenix, two of the higher strength pills could kill an adult, and one pill would kill a child who mistakenly ate one.
In 2012, prescription hydrocodone products generated $3.5 billion in sales on almost 131 million prescriptions and are the most commonly prescribed pharmaceutical products in the United States (Source® PHAST Prescription January 2012 - December 2012).
According to the CDC, deaths from overdose by prescription opioids have more than quadrupled since 1999, from 4,030 deaths involving the drugs in 1999, to16,651 in 2010. Overdose is a sign of the misuse of opioids, but the FDA and Zogenix both asserts the drug's benefits far outweigh the risks.
The company responsible for the manufacture of Zohydro, Zogenix, had been under scrutiny for a year, ignoring FDA recommendations about injecting a gel-like substance into the pills, making it more difficult for them to be crushed and snorted, upping the potential for abuse. While this requirement was only a suggestion, Zogenix chose to ignore it.
Another problem that bothered the advisory panel was the lack of scientific studies done on the particular patients the drug was intended for. Zogenix officials had told the FDA the painkiller was formulated for use in cancer patients in severe pain, yet it was never tested on this focus group.