zohydro

saw this this morning and thought i'd pass it along. sorry so long...p.m. ET Saturday and 7:30 a.m. ET Sunday.
(CNN) -- A potent little painkiller is causing a big stir.
A coalition of more than 40 health care, consumer and addiction treatment groups is urging the Food and Drug Administration to revoke approval of the prescription drug Zohydro.
The hydrocodone-based drug is the latest in a long line of painkillers called opioid analgesics. The FDA approved the medication last fall to treat chronic pain, and it is set to become available to patients in March.
"In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid," the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg.
"Too many people have already become addicted to similar opioid medications, and too many lives have been lost."
FDA approves 'frightening' pain pill Bill Clinton: U.S. popping too many pills Georgia's 'pill mill' problem grows Acetaminophen safe for pregnant women?
One addiction expert who signed the letter was more forthright.
"It's a whopping dose of hydrocodone packed in an easy-to-crush capsule," said Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. "It will kill people as soon as it's released."
The letter is the latest in a series of entreaties to the FDA related to Zohydro.
In December, 29 state attorneys general sent a similar letter to the FDA. The month before, members of Congress asked the agency to review its decision to approve the drug.
The concerns echoed by all groups are broadly about the drug's potency and abuse potential. They say they fear that Zohydro -- especially at higher doses -- will amplify already-rising overdose numbers.
"This could be the next OxyContin," says a petition on Change.org asking the FDA to reconsider.
Report: States failing to curb prescription abuse
According to the Centers for Disease Control and Prevention, prescription opioid deaths more than quadrupled since 1999 -- there were 4,030 deaths involving the drugs in 1999, compared with 16,651 in 2010.
"You're talking about a drug that's somewhere in the neighborhood of five times more potent than what we're dealing with now," said Dr. Stephen Anderson, a Washington emergency room physician who is not part of the most recent petition to the FDA about the drug. "I'm five times more concerned, solely based on potency."
Both Zohydro's maker, Zogenix, and the FDA assert the drug's benefits outweigh its risks.
"We do not expect the introduction of Zohydro ER (extended release) to increase the overall use of opioids," said Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, in an e-mail. "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."
Galer said the company will focus its commercial efforts on a small group of doctors with good experience prescribing opioids, so that only appropriate chronic pain patients would receive the drug.
Advocates for pain patients say that concerns about abuse, while valid for some, are not necessarily an issue for those patients.
"We know that a person with pain is not a person who abuses medications," said Paul Gileno, founder and president of the U.S. Pain Foundation, a group that receives some funding in unrestricted grants from the pharmaceutical industry. "A person with pain is a person suffering to get pain relief in order to live a fulfilling life."
Opinion: How safe are your prescription drugs?
In their petition to the FDA for approval, Zogenix representatives cited examples of patients who might benefit from Zohydro: a 46-year-old male with chronic back and leg pain who had two failed back surgeries; a 52-year-old female with metastatic breast cancer experiencing diffuse pain; a 32-year-old woman with multiple orthopedic fractures.
If Zohydro follows in the footsteps of its opioid-containing predecessors, such a narrow, focused patient group may expand -- to patients with low back pain, fibromyalgia, arthritis or countless other chronic conditions.
"The problem is, it costs a lot of money bringing a drug through clinical trials and then bringing it to market," said Anderson, past president of the Washington chapter of the American College of Emergency Physicians. "You have to anticipate (the drug company) being able to market and get its money back.
"I see this as a marketing ploy where eventually it's 'I've got bigger, I've got stronger, why don't you prescribe this,' and I'm terrified of that."
Dr. Sanjay Gupta: Let's end the prescription drug death epidemic
Bigger, stronger opioids -- especially those containing hydrocodone -- are a concern. Hydrocodone (Zohydro's sole ingredient) is one of the most frequently prescribed -- and abused -- opioids.
For that reason, in October, the FDA said it intended to shift hydrocodone-containing drugs from Schedule III to Schedule II. That rescheduling (still pending approval by the Drug Enforcement Administration) would mean much stricter dispensing and prescribing rules for hydrocodone-containing products.
At the time of that recommendation, the FDA posted a statement on its website that it "... has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States."
A day after announcing the proposed drug schedule change for hydrocodone, the FDA announced Zohydro's approval. It was a confusing juxtaposition, some say.
"Shocking, outrageous and genuinely frightening," said Kolodny of the Physicians for Responsible Opioid Prescribing.
FDA spokeswoman Morgan Liscinsky said that Zohydro's approval was separate and distinct from the agency's recommendation about rescheduling hydrocodone-containing products.
"I find great difficulty (with) the wisdom of the FDA's approval in terms of protecting the public's health," said Dr. Alex Cahana, professor of pain medicine at the University of Washington in Seattle, who was not among those who signed the letter to the FDA. "Risk-benefit thinking suggests that not everything we can do, we should do."
Zohydro will enter the market already classified as a Schedule II -- one reason both the FDA and the drug's maker are confident it will not contribute to the broader overdose problem.
Zohydro's labeling will feature warnings about abuse, addiction and misuse, and Galer said Zogenix is working on an abuse-deterrent version of Zohydro that should become available in three years.
None of those precautions has assuaged concerns. Anderson said that while a small subset of patients may benefit from Zohydro, unleashing such a potent drug in the current environment is unsafe.
"Put more of this kind of drug out on the street and, I'll see more overdoses related to this, no question," Anderson said.
Prescription drugs 'orphan' children in eastern Kentucky

Thanks Mark.I'm definitely curious about Zohydro.about it's effectiveness as an extended release pain med.

I'm also a little curious as to how Doctors will react to it's approval.How long will it be before they treat patients with it.

All will be revealed later I suppose.

Rick

Post Edited (tidalmouse) : 2/27/2014 7:16:28 AM (GMT-7)

This drug isn't tamper resistant. I guess they aren't thinking about the cost of the drug. Maybe they're thinking about addicts stealing it from patients who get it for legit pain. I have learned that common sense isn't common with these folks, meaning the ones doing the petition. Personally, I think that the REMS Advisory Committee and others are mad because the FDA didn't go by it's recommendation to now approve this drug.

That's technically one of the dumbest statements I've ever seen!! An addict never sits around thinking "oh this might mess with my liver " Every time they do the drugs they do in the amount they do them they're risking their liver!! Addicts don't go on transplant lists just as their alcoholic counterparts dont!!

The only difference in tylenol containing drugs versus not is the ability to safely inject the drug.

If you look at the stats on OD's due to rx pain meds, they make no sense. I don't believe the numbers, I don't believe the ones that have died were legimate pain patients who had their pain managed and/or did not die from other causes. I don't believe the COD was prescription meds alone, ie drinking, illegal drugs. The specifics just aren't anywhere to be read because no one knows what the specifics were. Someone having pain meds in their system doesn't mean that was the COD.

Merrida, Well said. You know if patients that were concerned about not being adequately treated were listened to instead of being dismissed as drug seekers. . and they banded together they may be able to yell loud enough. There seems to be countless people who speak up for the junkies who abuse these meds, but no one is interested in speaking up for those who need if for pain management.

But, for those who are Not receiving adequate pain management, and can't do the most basic things like take a shower or prepare a meal, they don't have the ability to go out and take this fight up. For those who are receiving adequate pain management and can do the things the want to do like grocery shopping, take vacations, go to movies, church, etc, they can't imagine they will ever be left without adequate pain management.

DianeB, I believe the powers that be and those such as pharmacist, drs, etc have been lied to when it comes to how many people have died that are chronic pain patients. When someone has a Cause and the energy, money, time and influence, they can get almost anything done. Those that have lost loved ones due to addictions, it is much easier to blame the drug and/or dr than it is to look at why they may have been a addict or why they didn't turn to family/friends for help. You also need to remember that in an election , things like how someone running for an office has tried to slow down the access to drugs. . that is good PR and it also wins elections. The picture painted is not correct or true, but most people aren't interested in that. All they want is to feel good about voting for and supporting a politician who is against the illegal use of drugs.

It also seems that those with the best insurance aren't feeling these restrictions, yet. And often those with higher income, better insurance are also the ones with the best political connections and who donate to campaigns. These laws aren't affecting them or their families.

What the reports and statistics don't say is the majority of deaths by legitimate patients or abusers are not always the sheer amount of drug in their systems it's the "accidental " part thats important yet not reported.

The method of delivery they used, snort, inject, etc.
The lack of understanding how a med is metabolized, ex: methadone's half-life, they ingest, no high, they ingest more, still no high, more and finally fall asleep, only to die 8-10 hrs later! Yet they died on a dose far lower then pts take daily?
opening fentenyl ingesting the gel, thats not anymore mcgs wise folks take every day but not all at once and 7days worth!

A few years back here, 2 teens were getting the "empty " methadone bottles out of the dumpster from one of the clinics and "rinsing " the bottles to get whatever was left?? They both died and their parents became the biggest opposition to methadone clinics, protesting, picketing, stirring up stuff with the media, how evil and dangerous this med is. The boys broke the law, trespassing, They had to have had previous knowledge of methadone to know that was going to work and get them high but all you ever hear is the evil of the med in conjunction with the story! The judge that awarded the parents money in wrongful death did nothing to ensure that its not a medication fault when ppl "accidentally Od "

It's the same theory that "guns don't kill people, people kill people "

If the truth was revealed how many Oxycontin overdoses were actually caused by breaking the release mechanism and getting too much med too fast? Thats not the medication fault its the person who did it is guilty.

When they start holding the people accountable and reporting the truth, these are not accidents they were intentional misuse by the people.

Thank you for opening this dialogue platform.

It's so simple to see how passionate we are, those of us who have proven to be responsible when taking our medications.

It's so complex to see how the media picks and chooses what details to release, and how to present them.

Society has turned into a frenzy where they are rewarded, on a social and legal level, to blame an inanimate object that has been illegally obtained, improperly used, (and my understanding was that to do so was a Federal offense, at least according to the labels on my rx bottles,...sharing the med, giving to another, using in any other manner than prescribed, etc.)...

Whatever happened to the human beings being responsible and accountable for their actions. These awards damage innocent lives and reward families of people who have broken the law. (Since they're the ones bringing lawsuits and news attention to the drug, not to their kid,--or whoever,--mixed drugs that weren't theirs with alcohol and abused them).

Okay, I need to take a deep breath now, because yes, that was a rant. It just irritates me that the stupid choices of some people have become so powerful that they're affecting the legitimate choices of responsible people.

..............................(breath)




M.

I'm right there with you Merrida. Thanks for saying what I've been thinking, and wasn't going to say.

love and hugs
Loretta

Kinda makes you wonder what the "real" motivations are for others. Thanks DianeB. It also makes you wonder what will happen when they have an abuse deterrent formula, if they lose approval now. It appears that the sale of Zohydro has already begun here, so it does seem kinda late in the game for the FDA to withdraw approval. Also Purdue is developing an extended release with abuse deterrent.

Purdue Developing Hydrocodone Drug to Rival Zohydro-
americannewsreport.com/nationalpainreport/purdue-developing-hydrocodone-drug-rival-zohydro-8823321.html

Post Edited (Mercy&Grace) : 3/25/2014 2:04:26 PM (GMT-6)

This is the place in the game our voices need to be heard. Pre-election time is the time when these idiots that we voted into office can realize they can be voted out too!!

Every Congressman,city official,state and even federal officials have websites and campaign websites,email,write letters that allow our voices to be heard.

You never have to leave the house,it costs nothing,and 9 times out of 10 we lose meds because there is no opposition to the bill.

I have absolutely no problems letting them know what I think! ! I may have very well helped put you in that job and since part of their jobs to help me,Then let them know how to help. Look at the sheer numbers of CPers and imagine what the loss of that many votes could do to a political career?

There was a time in my life I thought they dont listen to the people in majority and certainly my voice alones not going to warrant a response. I was proven wrong in 2001 after fighting SS for a year and a half and getting nothing but denial after denial.

I had used up my WC money on surgery and taking care of 5 kids alone,I was reaching my 5 year limits to draw welfare benefits since I had relied on several years of it while going back to college with 4 kids in previous years. I had no idea how we were going to live and on what.

A lady at a disability organization suggested I enlist the help of my Congressman to expedite my ALJ hearing which wasn't yet scheduled but slated for 12 to 18 months away. The backlog in Ky was long due to the rise in coal mine closings and the economy in general and the 5 yr rule placed on welfare payment.

She told me to go to the one of my choice and ask for help expediting due to a hardship? ? There's no way I believed this would get me anywhere but out of fear and desperation I emailed Senator McConnell. Within 2 days I got a response asking for a release of information, a eviction,foreclosure statement, utility cut-offs,unpaid medical on me and kids,anything that proved my statement of hardship. I sent it all and within 10 days I had a ALJ hearing set for 45 days later. The hardship he got carried on into my after approval time as well. The Judge that heard my case congratulated me after the hearing and gave me his decision immediately, no waiting weeks or months to know if I got approved.

Exactly 2 weeks to the day from my hearing my first backpay check was deposited and the 1 st check was issued on the 3 rd of that same month.

Less then 100 days of my first contact with the senator I had my hearing, approval, backpay,first check,and was now covered on Medicare. To me that was and is a result of me demanding he do what he swore to do during election campaigning. Work to make the lives of Kentucky's people the best it could be.

I will always be forever grateful to the Senator and his Aide as Im sure their hardwork helped. I spoke, they listened, and that's the job they were entrusted with.

Our voices are heard but if we all take the attitude that leaves it to others then there is nothing to be heard.

I understand we are not to get into political arenas here at HW but this is our lives, our future and I don't forsee anyone of us disputing that.

Take a few minutes and check to see how your politicians voted and let them know you appreciate their vote in good standing as well as your unhappiness with the votes that hurt us.

Mercy made it easy providing the links for us and thank you for that.