The January death of Hollywood legend Philip Seymour Hoffman sparked renewed focus on what's been called a "heroin epidemic": A recent increase in how popular the drug is, and how dangerous it's become. Considering this was partially brought on by a sharp spike in prescription-drug abuse in the last decade, it's pretty surprising that the FDA has just approved a new, high-dose painkiller: Zohydro, a hydrocodone-based opiod analgesic.
Sure, the FDA approves painkillers all the time, but this one contains ten times the hydrocodone of Vicodin. If all goes ahead as planned, it'll be available in March. Now, dozens of groups of doctors, experts, attorneys general, and consumer advocates are pleading with the FDA to reverse the approval.
Zohydro is so potent that one capsule contains enough hydrocodone to kill a child, and an adult whose body isn't used to opiates could overdose on just two capsules. It's intended to be an extended-release drug, but the capsules could easily be crushed so that the patient can receive the full dose in one go. This makes Zohydo an easy drug for addicts to snort or inject.
More than 40 healthcare, consumer and addiction groups have written an open letter to the FDA's Commissioner Dr. Margaret Hamburg, begging her to reconsider the approval.
"We ask you to put the public's health ahead of industry interests. In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid," the letter read.
Their plea was joined by 29 state Attorneys General, who also sent an open letter to Hamburg.
We believe your approval of Zohydro ER has the potential to exacerbate our nation’s prescription drug abuse epidemic because this drug will be the first hydrocodone-only opioid narcotic that is reportedly five to ten times more potent than traditional hydrocodone products, and it has no abuse-deterrent properties. State 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. This created an environment whereby our nation witnessed a vicious cycle of overzealous pharmaceutical sales, doctors over-prescribing the narcotics, and patients tampering with these drugs, ultimately resulting in a nationwide prescription drug epidemic claiming thousands of lives.
Last October, the FDA gave final approval to the drug. By doing so, it acted explicitly against the advice of the advisory committee it had appointed to review Zohydro, which voted 11-2 against the drug's approval in 2012. D
Despite this, the FDA and Zohydro's maker, Zogenix, insist that the drug's benefits outweigh any potential risks. Zogenix vice-president Dr. Brad Galer has said he didn't expect the availability of Zohydro to increase the use of opiods generally.
If put on the market in March, Zohydro will be classified as a Schedule II drug, which means it's a highly controlled substance unavailable without prescription and not approved for refills. The FDA says that it's confident this classification will prevent the drug from contributing to further prescription-drug abuse.
So far, it's not clear whether the various letters and petitions will have any effect on the FDA's decision to permit this drug. And the FDA already has a lot on its hands this week: The administration is currently holding hearings to decide whether to approve budding research that would, theoretically, create babies using three different people's DNA, with the goal of minimizing the risk of genetic disorders.
If the Zohydro release goes ahead, some doctors say there's a good chance we'll see a spike in overdose rates. "It will kill people as soon as it's released," Dr. Andrew Kolodny, president of advocacy group Physicians for Responsible Opioid Prescribing, told CNN.
Yikes. We'd give Zohydro a wide berth.