10/1/10 Companies that make unapproved versions of the drug colchicine, which is used to treat and prevent gout and familial Mediterranean fever, have been ordered by the U.S. Food and Drug Administration, or FDA, to discontinue manufacturing these pills within 45 days and to stop shipping them within 90 days.
The action means that within a few months, as pharmacies run through their supplies, the only kind of colchicine likely to be available to consumers will be a brand name version approved in 2009 called Colcrys.
So-called unapproved medications like colchicine are drugs that have been used by doctors since before the FDA began reviewing and approving new therapies in the 1960s, and they include medical mainstays like the painkiller morphine.
The FDA contends that these drugs may put patients at risk because they’ve never been reviewed for safety. Since 2006, regulators have been pushing companies that make and sell these older medications to put them through the rigorous approval process, which includes studying medications in clinical trials. In return, the manufacturers are promised market exclusivity for a period of time so they can recoup their supposed investments in the drugs.
The upside for consumers is that this effort will almost certainly help to identify potential dosing issues and drug interactions that were previously unknown to doctors and pharmacists.
The downside is that these unapproved medications, which are typically priced like generic drugs, will become much more expensive. In the case of colchicine, the retail price of the approved version, Colcrys, jumped from $.10 to $5 per pill.
After a chorus of criticism from doctors and patients, the manufacturer of Colcrys has added patient assistance programs that provide substantial price breaks for people hit hard by the increase.
The American College of Rheumatology, or ACR, has been encouraging other pharmaceutical companies to create more market competition for Colcrys; and on Sept. 30, 2010, Stanley Cohen, MD, the president of ACR, announced that a second drug company would apply to the FDA for the right to sell a branded form of the drug.
Read more about the colchicine controversy here.
Just for information purposes, I also found a bulk supplier that sells the raw material to make this medicine for .015 cents per pill.
What a disgrace the FDA is!
cripplled by gout and taking colcrys by the hour i have no relief
500 feet away in my car are my last few colchicine pills that would have had me walking hours ago
i am a stattistic
i didn't take a placebo i took the drug that worked for years and am now crippled by the innefectiveness of the new drug
thanks fda FDAWHORE
will i miss my son's wedding?
will i be able to crawl in time to the toilet?
FDA are........
pass this along-true storey
Used to pay around thirty for generic that did, and quickly.
email me your complaints to:
nothappywithurlpharm@gmail.com
I will gather them and send to the FDA and other Government agencies...call it apetition if you will. We have to fight back!
Urlpharma the maker sued the FDA in order to get all other Colchicine off the market.
Isn't there anything that anyone can do about this disgrace? If I knew how, I would start a company to market cholchicine off-shore, maybe in Canada. I'd love to see these crooks be put in their place.
A very unhappy MD, PhD with chronic intermittent gout.
$ 6500. We are not USA citizen and our insurance does not cover. We live in south America. I just want to say that is TERRORISM against this pacients and gout pacients . This is not have mercy .god save the pacients in your country, and my solidarity with them.
I just want to say this is what we call
TERRORISM for the pacients of USA and for the rest of the world . God save USA pacients .
His FDA agency is doing this as a precursor to the fulfillment of Obamacare. He had to CHANGE drug distribution in the country to pay back the pharmaceutical companies for their lobbying efforts during the Obamacare take over of our Health industry.
If you doubt this then why has it not happened before now. Like you will see in this article and comments included colchicine has been around a lot longer than America has. So why now after all these years of Americans taking the drug is it unsuitable now.
Power over the American people in the new American Socialistic Society being initiated by Obummer and his administration.
Wake up people to reality of your vote in America while we still have the power to take back our Country from these fools.
CHANGE is being given to us whether we like it or not. Before to long there is not going to be HOPE if we let it go to far. Stop listening to the main stream media like MS-NBC, NBC, ABC and all the other media outlets promoting this far left crap.
Start researching who these fools are we are putting in place in Government and not just believing what the media is feeding you. It is a lot easier now days with the internet until Obummer shuts it down which he and his administration are trying to do as well.
Control you see is what this is all about. Vote these fools out is our only option beside another revolution in America.
Way to go Obama.... we will all soon be to poor and insurance to costly to object to total Government takeover.
I am a 40 year old line cook that has no insurance at the time. I have lost my job due to the time off work. I cant walk or drive right now to find another job so what am I supposed to do now? thanks FDA I might have to get public assistance like food-stamps and or unemployment.
How the hell is that going to help our economy!!!! I guess that's my problem.
From Wikipedia:
Colchicum extract was first described as a treatment for gout in De Materia Medica by Pedanius Dioscorides in the first century CE. Colchicine was first isolated in 1820 by the two French chemists P.S. Pelletier and J. Caventon.[4] The alkaloid was later identified as a tricyclic alkaloid, and its pain-relieving and anti-inflammatory effects for gout were linked to its ability to bind with tubulin.
The precursor of colchicine Colchicum was described for treatment of rheumatism and swelling in the Ebers Papyrus, ca. 1500 B.C.[5] The use of Colchicum corm for gout probably traces back to ca. 550 A.D., as the "hermodactyl" recommended by Alexander of Tralles. Colchicum corm was used by ibn Sina Persian physician and other Islamic physicians, was recommended by Ambroise Pare in the sixteenth century, and appeared in the London Pharmacopoeia of 1618.[6] In 1833 P.L. Geiger purified an active ingredient, which he named colchicine.[7] Colchicum was brought to America by Benjamin Franklin; Franklin suffered from gout himself and had written humorous doggerel about the disease during his stint as Envoy to France.[
FEDERAL. That means follow the money, It means follow the lobbyists for the Big drug companies.
All of this shit will never stop as long as we take it. $ 4.00 a gallon gas, no comment from the feds. The IRS can basically take the money you make, like a bully taking your kids lunch money. That would be called extortion if a citizen did it, but its OK for the IRS to do it.
When are we as citizens of a country that our forefathers, fathers and we fought for going to fight to set ourselves free???
This is just one more move by a federally funded bureaucracy to make our lives miserable.
a friend of mines who resides in san diego also said he has found colchicine at the .1 mg in tijuana for 14 dollars per 30 tabs
hope this helps out
Who are the POS's that are involved in this money making scam??????????? Yes laugh…what goes around comes around…
And yes, where are the doctors in voicing their intellectual knowledge and standing up for their patients....
This is unjustifiable...another way of getting the rich richer and screwing 5 million Americans that have gout and the rest of the people that are paying for insurance to see their premiums go up by double digit percentages....where is it all heading to?
Who is the head of the FDA? Who is the CEO of Colchris? And where is Obamacare on this? We need to all write to all above and see the responses…or is it not in there interest to get involved and answer intellectually.
My gout has advanced to "chronic tophaceous gout" and I will not be able to function without colchicine and I am not going to pay for folders.
FDA scam to the max. May all members of the FDA and other government officials have major gout attacks - then they will com to their senses!
Hello,
I went to renew my colchicine that two of my family members have been taking for years for familial Mediterranean fever, FMF, flare ups.It is the only medication that work for FMF. The price is up from $10 per month per person to $150. This toooo much.
This is outrageous.
My guesses to the answers would be no, nothing and no. To me this seems like a perverse twisting of the laws to enrich a pharmaceutical company at the expense of patients and insurers.
I went to get the colchicine refilled yesterday. I was shocked at the price increase. Even at the new price, I will take the new colcrys because I have to.I just hope it works.
I am retired and on Social Security. I certainly do not need this additional cost. Is this some kind of conspiracy?
FDA: Bring the colchicine back!
This is really outrageous. My dogs have never had any side effects from the drug. Colchicine did nothing but help my precious Shar Pei's.
This is awful.
BILL NELSON & MARK RUBIO
Mark Rubio never did send a response back and the response (thanks for such an outstanding job of being responsive and respresenting us!!)
Bill Nelson's office response(per Karen Meister, Affairs Specialist) seemed to be the of a typical political response and sided with the FDA's idiotic viewpoint.
No one in congress seems to be taking this seriously. They all will stand up on their plateforms and preach how we need to control healthcare costs and THEN THIS!!
Hey you idiots at the FDA. Why the hell do you think we prescribers pay malpractice insurance? Yeah, we prescribers are responsible for the safe administration and monitoring of medications THAT's WHAT WE GET PAID TO DO!!! . Cholchine has always been a presciption and we've been using cholchicine for centuries!!! And all of a sudden, there's a problem!! They don't sue you, they sue us!! You best continue you're approval studies on products like Chantix and the like (should I go on with all the plunders of products that went through your approval process only to be found to have serious problems later!!!)
I was outraged too, espically for my patients that have for years gotten relief from cholchicine. Many of them just can't afford the fifty fold price increase and I'm not completely convinced yet about these assistance programs yet.
It should be noted that the manufacture of Colcrys (who performed the limited studies) will get EXCLUSIVE rights to the manufactue of cholchicine. How many years they will have the rights I do not know, but I bet it's a really sweet deal. (Humm?? Was someone high up in the FDA appointed during the Bush Administration??)
I assume the canadian pharmacies can still deliver generic cholchicine.
is open to anyone just go to website
and sign up,my 30 pill precription at rite aid is 81 dollars,better than 172
my union wont even cover it its adisgrace.
ive used colchicine for years with no probs now im in hell
FREEDRUGCARD.US
USE IT
The excruciating pain of a gout flare-up is completely incapacitating. It is unrelenting.
I urge every American, when speaking to any of your legislators, to shake their hand, look them in the eye, and before releasing their hand, demand them to tell you what THEY
are going to do to reverse this asinine decision of the FDA. Maybe they just don't
care about the 5 MILLION Americans affected by this disease.
Don't let them even start to talk about tests
required and the cost. Colchicine is nothing
more than ground up crocus stamens for cripe
sakes. The administration of any drug must
be done with caution. Is any drug completely
safe for everyone? Tylenol is taken by billions of people despite potential serious complications in some (including death) from
drug interactions, allergies and O.D. So I
guess we need to take peanut butter off the shelves right now, except for PNUTTY brand,
who submitted the results of their clinical
trials which showed eating 5 pounds of it all at once could affect respiration.
Well I have joined the ranks. I went to renew my colchicine that I've taken for years for my occasional gout flare ups,I was told that it had been recalled and that I would have to have my Dr. give me a new script for colcrys because it was non formulary.The colcrys cost $172.00.I was only paying $4.00 before for a 30 day supply.
This is outrageous.
The reason I needed some was curious. I've been taking Allopurinol for years and it works great to prevent the crystals (tophi) from forming in joints. However, I started taking an Allopurinol generic from manufacturer named NorthStar. That perticular generic has failed me. I wouldn't say it has the same effect on everyone, it could just be my physiology. My gout problem returned in a different spot first - tendons/ligament in my shoulder. because it was there and had been so long since I've had an attack, I didn't suspect.
Then, several weeks later, the familiar pain was in my elbow and before I got to the doctor to get colchicine (Allopurinol prevents by blocking, colchicine kelates the crystals out of the system), my ankle.
Now I got what I will need and will switch to another Allopurinol generic or perhaps the Xyloprim, but next time, my insurance company will end up paying lots more.
We have taken the insurance companies to task as of late, but I'm on their side on this one. The FDA shouldn't stop a medication from use that has been used for about 400 years because they don't have study results. That's stupid. Do the testing and make an appropriate assessment with the results and have another plan of action that doens't enrich one company and cost many Americans and insurance companies a bundle.
Unless FDA is getting something out of it, it doesn't make sense ;)
this is wrong all the way,when will americans wake up?
I have been taking colchicine for ten years and it`s great. Every time the FDA or "so called government" gets involved we the people get screwed. Who are the stock holders?
The enormous projected increased cost of colchicine (5,000 times the present cost) will be very tough on our family budget. I pray that something will be done to change this situation. I really depend on this drug.
I too will send a letter to our representative!
THIS MEDICATION HAS BEEN GRANDFATHERED IN, INTO THE SYSTEM AS IT WAS KNOWN AND USED WELL BEFORE THE FDA WAS EVER THOUGHT OF. Now some company comes along, most likely with under-the-table tactics, to have only ONE company make this med and charge what ever they want, and come along with some BS about how they will help you pay for the med, it you can't afford it. This is total BS, plain and simple. This is not the only med you are going to find this happening to, get ready for Aspirin to be one of the next ones, and more meds that have been GRANDFATHERED IN, so ONE company will have total control over the meds for years.
WE NEED TO WRITE TO OUR CONGRESSMEN AND VOICE OUR OPINION AND DISTRUST OF THE MEDICAL COMPANY AND THE FDA RULING. WE SENIOR CITIZENS ARE BEING TAKEN FOR A RIDE IN THIS COUNTRY, WHEN IT COMES TO MEDICATIONS AND THEIR COST. IT IS TIME FOR US TO START TO STAND UNITED AND CHANGE THIS BS, ONCE AND FOR ALL.
And of course we seniors don't need a "raise" this year to cover extra expenses like this because our cost of living couldn't possibly have gone up. A ten cent pill becomes a $5.00 one? If that isn't inflation, what is?
As stated 50 years of happy treatment ignored, in the name of safety they push prices up and make pharma even richer!!!
From approx. 10 cents per pill colchicine will rise to abt $5.00 per pill. URL Pharma has said it will offer a PAP but the program is highly intrusive in the private financial affairs and leaves many either without treatment or in debt.
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