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.
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