A new painkiller that packs large amounts of hydrocodone into a single pill has quickly become one of the most controversial medications in years to receive U.S. Food and Drug Administration approval, as health officials debate whether its benefits outweigh the likelihood of being abused.
Zohydro, which is manufactured by the pharmaceutical company Zogenix Inc., is comparable to the painkiller Vicodin, said Dr. Brian Durkin, director of the Center for Pain Management at Stony Brook University Medical Center.
But unlike Vicodin, which has between five and ten milligrams of hydrocodone in a single pill, Zohydro can contain up to 50 milligrams depending on the prescribed dose — making it up to five times more powerful than the highest dose of Vicodin currently on the market.
In addition, unlike Vicodin and other opioid painkillers, Zohydro pills do not include an embedded tamper-resistant mechanism, meaning abusers can easily crush them and snort them or dissolve them in a liquid to be injected.
“We’re risking having another Oxy-Contin crisis,” said Dr. Durkin, recalling a 1996 spike in prescription drug abuse that occurred after another hydrocodone pill hit the market without a tamper resistant mechanism.
In 2010, OxyContin was reformulated to include a system in the pill that prevents people from crushing it. “It turns into a paste,” he explained.
“We’re going in the opposite direction of where we should be for these dangerous drugs,” the doctor said. “I am surprised they approved it.”
Dr. Durkin isn’t the only one: Sen. Charles Schumer (D-NY) held a press conference Monday calling on the Department of Health and Human Services to reverse the “confounding” FDA decision or at least pull the drug until it is tamper-resistant.
Anti-addiction activists have also called on the FDA to revoke its approval of the controversial drug.
Overdose deaths in the U.S. due to prescription painkillers have increased 300 percent since 1999, according to the Centers for Disease Control and Prevention. In 2010, 2 million people — nearly 5,500 each day
— reported using prescription painkillers the fi rst time for nonmedical purposes.
In Riverhead, Community Awareness Prevention executive director Felicia Scocozza said she has seen an increase in prescription drug abuse since she started at the nonprofi t in 1999. While rates of abuse are lower in Riverhead than in the rest of the county, she said, “across Long Island, it’s becoming a huge problem.”
Zohydro, which could hit the market sometime this month, was granted FDA approval in October — despite an overwhelming 11-to-2 vote against that approval by the FDA’s advisory committee, Dr. Durkin said.
So what is so special about the new drug? Dr. Durkin said he isn’t really sure.
“There are plenty of drugs on the market now that are just as good,” he said. “I don’t see any need for this. Not these days.”
Hydrocodone is the most prescribed pain medication in America, given most often following surgery, Dr. Durkin explained — but for longterm chronic pain management, its use is still “controversial.”
“Frankly there are other drugs that have better efficacy and better patient safety profi les than hydrocodone,” he said. “I don’t see myself needing to prescribe this.”
On Monday, Pamela Mizzi, director of prevention with the Suffolk County Resource Center, said she agreed.
“It’s a legitimate controversy,” she said. “On one side, you have the addiction professionals — and I’m a substance abuse counselor — who feel strongly that there is not the need for another variety of hydrocodone to be available. Especially without the anti-tampering preparation.
“But on the other hand,” Ms. Mizzi said, “there are people who have legitimate needs for pain and pain management.”
Dr. Durkin and Ms. Mizzi said the only advantage of Zohydro they can see is that it does not include acetaminophen (tylenol), which some patients cannot have. But there are still other usable alternatives.