Massachusetts Declares Health Emergency, Bans Zohydro

Massachusetts Declares Health Emergency, Bans Zohydro

Massachusetts Gov. Deval Patrick has declared a public health emergency in his state over the “growing opioid addiction epidemic” and ordered state health officials to take several steps to combat overdoses, help drug addicts and find a long-term solution to opiate abuse in Massachusetts.

One of his first steps is an unprecedented ban on Zohydro, the first pure hydrocodone painkiller sold in the U.S. Some addiction treatment experts have claimed that Zohydro – which came on the market just a few weeks ago – will fuel a new wave of narcotic abuse and overdoses.

bigstock-American-Drugs-43798741-300x225“The introduction of this new painkiller into the market poses a significant risk to individuals already addicted to opiates and to the public at large,” the Governor’s office said in a statement.

Patrick’s order prohibits the prescribing and dispensing of any hydrocodone-only formulation until adequate safety measures are in place to safeguard against the potential for diversion, overdose and misuse. Zohydro was introduced without a tamper resistant formula to discourage addicts from snorting or injecting the drug.

San Diego-based Zogenix (NASDAQ:ZGNX), which makes Zohydro, said it was “extremely concerned” by the governor’s decision to ban a prescription medication that was approved by the Food and Drug Administration.

“We are disappointed that today legitimate severe chronic pain patients in Massachusetts received a serious blow in their efforts to find relief for the suffering that affects their – and their families’— daily lives,” Zogenix said in a statement. “Ultimately, the ban on the prescription medication will add to patient suffering in the state.”

Zogenix claims Zohydro is actually safer than other hydrocodone combination products, such as Vicodin, because it does not contain acetaminophen – which can cause liver damage at high doses.

Addiction treatment experts have claimed Zohydro is 5 to 10 times more potent than Vicodin and have warned it is more likely to be abused by drug addicts because it does not come in a tamper resistant formula.

Zogenix says Zohydro is being unfairly singled out.

“Over the last 12 months, more than 360,000 prescriptions for extended-release opioids were dispensed in Massachusetts, and a significant majority did not have FDA-approved abuse deterrent claims,” Zogenix said.

“We fail to see how banning the sale of a single new product will achieve the governor’s policy objectives when all of the products that are currently part of the epidemic remain available for sale in the state.”

Massachusetts is the first state to ban Zohydro.  The FDA is under growing political pressure to reverse its decision to approve Zohydro over the objections of its own staff and advisory committee, which warned Zohydro could be abused even more than currently available hydrocodone products.

Senator Joe Manchin, a West Virginia Democrat has introduced a bill in Congress to force the FDA to withdraw its approval of Zohydro.

The increased use of hydrocodone, oxycodone and other narcotic painkillers is often blamed for a nationwide surge in heroin addiction. At least 140 people have died from suspected heroin overdoses in Massachusetts in the last several months. From 2000 to 2012, the number of accidental opiate overdoses in the state increased by 90 percent.

“We have an epidemic of opiate abuse in Massachusetts, so we will treat it like the public health crisis it is,” said Gov. Patrick.

In addition to the ban on Zohydro, Patrick ordered state health officials to allow paramedics and other first responders to carry Naloxone, a medication that can reverse the deadly effects of an opioid overdose.

Massachusetts will also require physicians and pharmacists to use the state’s prescription drug monitoring program to keep better track of the drugs that patients are using. This was previously a voluntary program.

The Governor’s office will also dedicate an additional $20 million to addiction treatment programs.

“We truly are in a state of emergency when it comes to opiate addiction, and the Commonwealth has had to do a lot with limited resources,” said Congresswoman Liz Malia. “Expanding services will fill some of the existing gaps in the system and allow those in need to access treatment in real time – when they need it and in the most appropriate setting.”

“Those of us who have spent our careers working in the addiction treatment field have never experienced anything that approaches the current opiate abuse epidemic,” said Chuck Faris, CEO of Spectrum Health Systems. “The pain inflicted on families, the increase in crime and the loss of lives is unprecedented.”

Authored by: Pat Anson, Editor

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I hear ya………. Bad when ya have to beg for help to live a half way normal life…:(

trudy myers

I am sick of hearing how drug addicts are going to get our medication-what the dumbasses cant seem to figure out is drug addicts are not buying from patients-they buy them on black market in larger scale. Pain patients get 30 days of pills and they check our pee to see if the drug is being taken and they do random pill counts. I also am sick of being in grueling pain yet my md’s are afraid to treat me with narcotics now. I am hurting everyday!! all day and night-I am exhausted from fighting it

dave

Annie- I agree with you regarding the rights of people in pain. That is why i created the American Pain Rights Act Petition to empower people in pain to have a greater voice and more power in decisions that affect pain research, regulations and treatments. 6 people have signed on this week. I hope to send the petition to Obama by September- i need ore signatures. I hope you will take a look at it and it is easy to sign, Let us stop Governors, doctors, the DEA, medical boards, pharmacists from telling us what we can and cant have without our advice and consent.
http://www.petitiononline.com/petitions/painra/signatures?page=4

I too have had severe pain.. 3 failed surgeries..and massive scar tissue pressing on my leg nerves… I have such bad pain I can only go from my bed to my chair. I think ( Actually I know)if a patient has a legit pain situation and can prove it…. they should be given meds to help deal with everyday life…and live a half way pain free life. I have exrays showing my surrgeries.. papers stating my probs. and I still get ripped trying to get relief from a pain DR that has been with me for many yrs prior to my surgeries NOW When I am at my worse….he wants to stop my life by taking me off the ony thing tha helps and it is a very low dose of Vicoden.. 5 mg….I am 66 yrs old.. I am not looking to get a BUZZ whatever that means , I Just want to live out the rest of my life and be able to go shopping.. on a vacation maybe since I cant even take a 20 min car ride right now from the pain.. why do ppl get pain meds and then sell them when ppl like myself needs them?? I Just dont understand

Monk

The Governor’s word is not a substitute for legislation. As such, this is little more than political posturing. Additionally, follow the money. Odds are, this Governor is tied a rival pharmaceutical company much like Joe Manchin and his daughter.

Annie Saka

Patients in Pain need to stand up for your rights. If you don’t then you have Senators and Governors and others trying to play doctor. We don’t need the political figures of this country telling us which medicines we can have. ZohydroER is a niche product which the FDA has APPROVED and the company Zogenix is a RESPONSIBLE company who actually cares about the 100 Million Plus Americans in Pain across this country…they are the ones who broke their backs building this country, and now when they are in need of relief Politicians are trying to stop them from getting any amount of relief to continue living the best life possible?? Yes there are other products available…but None are Acetaminophen free…If your in need of a pain medication for the long term use of Chronic Pain then please take a look at ZohydroER and visit their website Zogenix.com all the information is on their site. Including doages that ZohydroER is available in, 10mg and up. Your Doctor will decide which dose is correct for you. Don’t buy into the FEAR that these Political figures have created..in my personal opinion we need to PROTECT the rights of the patients in need first. No medication that is FDA approved should be kept from the Chronic Pain Sufferers in AMERICA. Also you can call Zogenix yourself and they will be happy to talk with you and answer any questions you might have. The number is on their website also.
1-866-ZOGENIX (1-866-964-3649)

Marty

Unless the Gov has a license to practice medicine who the hell does he think he is to determine what pain meds people in chronic should be taking. Shame on him for causing more pain to some people. Lets hope his life doesn’t change in 24 hours like mine did and that he doesn’t get the pain meds he needs to be able just barely function around home. You are so wrong!!! He has no right to do this to peoples lives. He needs to be stopped.

Dennis Kinch

OMG! Just more fear mongering with the legal user in the crossfire. If a state governor believes this crap what chance is there for truth? They can’t stop the illegal users so watch what they do to the patients. There will be some insidious rules coming down and it will be really tough to get scripts filled.
They keep doing this. Notice the complete lack of numbers to cite their case? That tells you this was a political move. Someone pressured someone. And it’s tied to the US Congress. Using fear to make political moves.
How many overdoses were from legitimate patients? Why mention heroin in the article? How many patients become heroin addicts? Isn’t there rules for banning things? If it’s approved by the FDA, can a state just ban it because they feel like it? More questions for the NPF survey.
If this is a state of emergency and an epidemic, what would they call the state of chronic pain patients? Armegeddon?

Christina

This ignorance right here are why pain patients are suffering. Were are the pain patients rights? thats right we don’t have any because we have addictive behaviors. We are profiled and a pharmacist gets to play power trip with our treatments. They can’t figure out in five minutes wether or not a patient needs pain medication or not. Pain patients needs rights too. Pain patients need other options if something is not working and this medication allows someone to start on the lower end of line of pain medications. Maybe be the only ONE they need. Politics needs to stay out of the circle or pain treatment period.

Michael Schubert

Ban hydrocodone, the weakest opiate on the market, while leaving oxymorphone, fentanyl, morphine and methadone available?? None of those meds have tamper-resistance and are many times MORE POTENT, MUCH cheaper and readily available than Zohydro. Makes zero sense. Absolutely none whatsoever. What does this guy want, pain patients to take STRONGER medicines so they can’t work or function in life? There is no alternative to Zohydro for many patients. I have a ruptured C4-5 & C5-6 discs. Fusion=disability, and I cannot function on strong medicines like OxyContin, Opana or others. Are you really trying to protect criminal addicts from themselves over legitimate patients such as myself, who had no choice to be like this?? Absolutely shameful. If these are finding their way to the streets, penalizing people that need them is definitely not the answer

Drug addicts don’t care about acetaminophen/paracetamol content, pain patients do.

Zohydro would have been great for people who need around the clock relief, but don’t need OxyContin. Now, they’ll just get OxyContin, MSContin, Opana ER (generic not abuse deterrent), or Duragesic.

Anyone can bypass abuse deterrents if they want to abuse the drug. Pain patients can’t always absorb abuse deterrent formulas. I went into withdrawal when I went from 40mg/8hr OxyContin to 80mg/8hr abuse deterrent OxyContin. Abuse deterrent drugs are tested on HEALTHY people, with healthy intestines. Brand Opana ER had no effect on me. When I switched to non-abuse deterrent oxymorphone ER, I overdosed

The question has to be asked .. is Gov Patrick technically practicing medicine without a license ?

and

Is Gov Patrick interfering with chronic pain pts receiving appropriate therapy?

Maybe they need to change the name of the state to
Nannychusetts ?

here are some additional thoughts
http://www.pharmaciststeve.com/?p=5369

Bill

Yup, screw people in chronic pain and make
The drg dealers richer!