A new painkiller drug called “Zohydro,” dubbed by critics and consumer watchdog groups as “frightening,” is set to hit pharmacies in March. Dozens of concerned health care agencies have now partnered in their fight against this highly addictive, opiate drug.
According to CNN on Feb. 26, over 40 consumer health experts have sent a letter this week urging the U.S. Food and Drug Administration to revoke its approval of the supercharged painkiller. The FDA rolled out the highly potent painkiller despite the fact the FDA’s very own advisory committee voted 11 to 2 against the drug.
Public Citizen, a public health group that has the mantra “Protecting Health, Safety and Democracy,” says Zohydro is “so powerful that a single dose could kill a child.”
“I’m amazed that the FDA would approve a dangerous new [medicine] over the strong objection of its advisory panel,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in the group’s news release. “In the midst of a severe epidemic of opioid addiction and overdose deaths, this is the last thing we need.”
An excerpt from Public Citizen’s Feb. 26 press release:
Earlier this month, three U.S. senators raised concerns about the drug and asked the FDA to explain how it will prevent misuse. Writing on behalf of “groups on the front-line of the nation’s opioid addiction epidemic,” the organizations said there is no need for another high-dose opioid.
“Too many people have already become addicted to similar opioid medications and too many lives have been lost,” said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. “The FDA should exercise its responsibility to protect the public’s health by reversing its approval of Zohydro.”
The opioid (prescription narcotic) painkiller will be made by pharmaceutical companies Zogenix and Alkermes.
Medicine.net explains why the drug is so potentially dangerous, and addictive: “Unlike other prescription painkillers such as Vicodin, which combine hydrocodone and acetaminophen, Zohydro is the first single-ingredient hydrocodone drug ever approved.”
The United States has an alarming use of prescription hydrocodone. Narcotic prescriptions have soared; addiction rates have followed suit. The U.S. comprises only five percent of the globe’s population, yet we consume over 90 percent of the world’s supply of hydrocodone.
“Shocking, outrageous and genuinely frightening,” said Kolodny of the Physicians for Responsible Opioid Prescribing.
A Change.org petition has been started by the Fed Up Coalition, asking the FDA to reconsider their approval of the drug. “This drug is the first form of pure hydrocodone on the U.S. market and does not contain any abuse-deterrent qualities, thus it may be easily tampered with. This could be the next OxyContin,” the introduction to the petition reads.
However, not all groups are rebuking the FDA over Zohydro. Proponents say the drug is needed for those with severe pain issues.
“We know that a person with pain is not a person who abuses medications,” says Paul Gileno, founder and president of the U.S. Pain Foundation. “A person with pain is a person suffering to get pain relief in order to live a fulfilling life.”
Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, one of the companies that are manufacturing Zohydro, said: “We do not expect the introduction of Zohydro to increase the overall use of opioids. In fact, prescription data from the last five years shows that total use of ER opioids is constant and independent of new entrants to the market.”