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 The opioid drug, manufactured by Zogenix Inc,
contains a potent amount of an active ingredient that could be
lethal to new patients and children and is not safer than other
current pain drugs, the groups told the Food and Drug
Administration.
"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," they wrote in a petition to FDA Commissioner
Margaret Hamburg, dated Wednesday.
In December, attorneys general from 28 states also urged the FDA to
reconsider its approval of the drug.
Zogenix, in a statement, said it was confident in the FDA's approval
of the drug, which will be "subject to stricter prescribing and
dispensing rules." The company has said it plans to start selling
the drug in early March.
The latest petition comes as the United States grapples with an
epidemic of prescription drug abuse, especially involving powerful
opioid pain medications. Opioids are a class of drugs that includes
morphine, codeine and oxycodone as well as hydrocodone.
Nearly 5 million people in the United States ages 12 and older abuse
pain drugs, outpacing sedatives, stimulants and other abused
medications, according to a 2012 U.S. government survey.
The FDA, which has launched its own efforts aimed at curbing abuse
of pain-killing medications, approved Zohydro last year despite
earlier concerns from a panel of FDA outside advisers worried about
addiction risks.
The FDA advisers echoed the concerns of public health experts, law
enforcement and others, who pointed to the drug's delivery system
and say they are worried about the potential for Zohydro to be
crushed or injected.
Zohydro can contain as much as 10 times the amount of the narcotic
hydrocodone as other painkillers such as AbbVie Inc's Vicodin or UCB
Inc's Lortab, advocates said in their petition.
"Zohydro is not safer," they wrote.
Both Vicodin and Lortab also contain the pain-killing ingredient
acetaminophen. Zohydro does not.
FDA officials have
said they are working to balance public health worries about opioid
addiction with access to the drugs for patients seeking pain relief.
The FDA has said Zohydro's benefits outweigh its risks.
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FDA spokeswoman Morgan Liscinsky said the agency would review the
group's letter.
The petition was signed by 42 supporters, including representatives
of advocacy groups such as Public Citizen as well as physicians and
community addiction treatment providers.
In October the FDA recommended tighter restrictions on products that
contain hydrocodone, and on Thursday the Drug Enforcement
Administration proposed a rule that would reclassify hydrocodone-containing
products.
Until now, Vicodin and other products that contain less than 15
milligrams of hydrocodone have been classified as Schedule III
controlled substances. The DEA proposes reclassifying them more
restrictively, as Schedule II products, in line with opioids such as
morphine and oxycodone.
Reclassifying the products would make them harder to obtain, both by
addicts and by legitimate pain patients. Physicians are not allowed
to call in a prescription for a Schedule II product to a pharmacy.
Instead, patients must present a written prescription.
Last year an advisory committee to the FDA voted in favor of
rescheduling the products. In December the Department of Health and
Human Services sent the recommendation to the DEA.
Shares of San Diego-based Zogenix closed down about 2.6 percent at
$4.56 on the Nasdaq.
(Reporting by Susan Heavey; Editing by
Jeffrey Benkoe and David Gregorio)
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