28 States Ask FDA to Rethink Painkiller Approval
By MATTHEW PERRONE, AP Health Writer
WASHINGTON (AP) — More than two dozen state prosecutors are asking the Food and Drug Administration to reconsider its approval of a powerful new painkiller called Zohydro, saying that the narcotic pill could add to the national epidemic of prescription drug abuse.
The FDA approved Zohydro in October, making it the first single-ingredient hydrocodone drug ever cleared for U.S. patients. The pill uses an extended release formulation that is reportedly five to 10 times more potent than currently available hydrocodone combination pills, such as Vicodin. The approval surprised many doctors, since an FDA advisory panel previously voted overwhelmingly against the drug, citing its potential for abuse.
The letter from 28 states attorneys general asks the FDA to revoke the drug’s approval or require manufacturer Zogenix to quickly reformulate the drug so it is more difficult to abuse. Zogenix has said publicly it is working on a harder-to-abuse version of the drug. In recent years several drugmakers have developed tamper-resistant versions of popular painkillers. Generally these formulations make the tablets difficult to crush, so they cannot be snorted or dissolved for injection.
“States attorneys general do not want a repeat of the recent past when potent prescription painkilling drugs entered the market without abuse-deterrent qualities and without clear guidance on how they were to be prescribed,” states the Dec. 10 letter, which was also signed by the state attorney of Guam.
An FDA spokeswoman said Thursday the agency is reviewing the letter and will respond directly to the attorneys general.
San Diego-based Zogenix Inc. did not immediately return calls and emails requesting comment.
Before Zohydro’s approval, hydrocodone was only available in combinations with other non-addictive pain relievers, including acetaminophen — the other ingredient in Vicodin. The presence of these extra ingredients was thought to make the drugs more difficult to abuse, though many experts now dispute that idea.
In 2011, U.S. doctors wrote more than 131 million prescriptions for drugs containing hydrocodone, making it the most prescribed medicine in the country, according to government figures. Hydrocodone also consistently ranks among the most-abused medicines in the U.S., according to the Drug Enforcement Administration.
The drug belongs to a family of medicines known as opioids because they mimic the active ingredient found in the opium poppy plant. Others opioids include morphine, oxycodone, codeine and methadone.