Posted on 02/10/2010 2:02:41 PM PST by neverdem
DR. FUDMAN is in private practice in Austin, Texas. He reports that he has no conflicts of interest.
The price of colchicine is increasing by 50-fold, from about $0.10 per tablet to $5 per tablet, unless physicians and patients can convince the Food and Drug Administration to allow the colchicine made by generic manufacturers to stay on the market. A twice-daily dose of colchicine will increase from $6/month to $300/month because one company has taken advantage of FDA rules and the orphan drug law to the detriment of patients.
Colchicine has technically been an “unapproved drug” rather than a “generic drug” as it predates the law that required drugs to be approved by the FDA. In recent years the FDA has been encouraging companies to do the studies to get these drugs approved by offering an exclusive marketing period, and removing some of the unapproved drugs from the market. To that end, Mutual Pharmaceutical Co./URL Pharma performed a clinical trial comparing two dosing regimens for acute gout, did some drug interaction studies in normal volunteers, and branded their previously generic/“unapproved” colchicine product as Colcrys.
The FDA approved the drug with exclusive marketing rights for gout for 3 years and for Familial Mediterranean Fever for 7 years; the longer exclusivity period for its use in Familial Mediterranean Fever is because that indication qualified it as an orphan drug. This by itself does not mean the other manufacturers of colchicine can't continue to sell the drug, only that their formulations can't be FDA-approved. Now that there is an FDA-approved drug available, however, most industry observers expect the FDA will stop the sales of the unapproved versions. But this is not mandatory, and we must urge the FDA to use its discretion to not ban the sale of unapproved colchicine.
Not waiting for the FDA to act, Mutual/URL tried to eliminate its competition by filing suit against the other manufacturers of colchicine a few days after gaining approval of its version, claiming that merely by listing their colchicine for sale it falsely implies their products are FDA approved. A request for a preliminary injunction to stop unapproved colchicine from being sold was denied, with the court noting that the plaintiff was doing the very same thing until the day before Colcrys was approved, but the suit is pending. Meanwhile, either anticipating the FDA will ban the sale of unapproved colchicine or because of the lawsuit, three of the other four companies have stopped making colchicine. The one remaining competitor has raised the price to match Mutual's $5/tablet.
Although Mutual's formulation of colchicine gained approval as an orphan drug for Familial Mediterranean Fever, the company conducted no new clinical trials with patients with FMF. The package insert states the evidence for efficacy in FMF and for gout prophylaxis “is derived from the published literature”—studies that ironically used the same unapproved colchicine that Mutual/URL seeks to force off the market. They have so perverted the orphan drug process—a process intended to facilitate the development of new drugs with a small market—that it has made an old drug less available instead of making a new one more available.
The FDA should acknowledge the unintended consequences of its actions and announce that it will not remove unapproved colchicine from the market. Only then will generic manufacturers resume making colchicine available for pennies a pill, as they had been doing for decades.
Want to get involved? Tell FDA what you think by writing: Dr. Margaret Hamburg, the FDA commissioner, at margaret.hamburg@fda.hhs.gov, and Dr. Janet Woodcock, the director of the FDA Center for Drug Evaluation and Research, at janet.woodcock@fda.hhs.gov.
I believe is prevents the chromatids from separating during mitosis.
Does aspirin fit this category as well?
Colchicine is an old old remedy for gout. It absolutely stops a gout attack for me. If I feel an attack coming on I take a regimen of 3 to 6 pills over a day. And it stops the attack. This happens to me maybe once or twice a year.
If anyone has ever had a full blown gout attack that may put you down for a week to ten days in excruciating pain, colchicine may be a miracle cure. It is for me!
If the FDA permits the price to skyrocket, I may have to grow my own. I understand it is a plant extract. Does anyone know?
So why would they use it in people who could be reproductive???
Colchicine is extremely toxic and is extremely useful for gout. 10 tablets at once can kill, easily. I have it in the medicine cabinet in case a gout attack occurs. Will stop an attack in 36 hours flat. Normally, allopurinol keeps me from having any symptoms.
“Colchicine is an old old remedy for gout. It absolutely stops a gout attack for me. If I feel an attack coming on I take a regimen of 3 to 6 pills over a day. And it stops the attack. This happens to me maybe once or twice a year.
If anyone has ever had a full blown gout attack that may put you down for a week to ten days in excruciating pain, colchicine may be a miracle cure. It is for me!”
I have gout, and I’m on a daily regimen of 100mg Allopurinol. Like you, I will still get the occasional gout attack. On days when I feel one coming on, I’ll take an extra Allopurinol pill, and it usually goes away. If that doesn’t work, I’ll open my Colchicine bottle and pop a pill an hour for 4-6 hours, until the terrible stomach cramps and explosive diarrhea starts. After about 4 hours on the toilet, the gout pain goes away. I hate taking Colchicine, but a full-blown gout attack is just about the worst pain I’ve ever experienced.
Autumn crocus. But don’t fool around, difference between therapeutic dose and organ-damaging dose is very small. I can tolerate only two tablets a day.
I’ve found that if I avoid cashews I don’t have attacks. Other purine-rich foods might be similar.
As I hinted in the other comment, my bathroom expedition starts with the third tablet.
This is info worth saving/reading.
Thanks
Dark beer and prime red meat are my enemies. It’s too bad they’re also my two favorite foods. The weather also seems to be a factor. If I have a prime rib dinner with a tall glass of Guinness the evening before a low pressure front moves in, I’m 100% guaranteed to have an attack the following morning.
It seems that anything that makes uric acid sediment out of the bloodstream potentiates an attack. One time my foot got out from under the covers on a cold night and I got an attack. My doctor used to poo-poo that, but I know it happened.
Osteopathic care may ease late-pregnancy back pain
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FReepmail me if you want on or off my health and science ping list.
http://www.bornagainamerican.org/index.html
Rename, repackage, rewrite it a tad smaller, and sell another pig in a poke.
Tennessee has joined several other states in trying to pass a Health Care Freedom Act. NO COLAs for granny, retired Military or retired fed employees. BIG NEW fees for Tricare for Life retired over 65 Military's secondary health ins. (DOD bill already passed, delayed but goes into effect 2011)
New Dem mantra: Woof, woof eat dog food granny....ala let them eat cake.
Bambi doesn't keep his promises...so buyer beware.
Obama Plans to Undo Bush Rules on Oil Drilling on Public Lands, Among Others
http://redgreenandblue.org/2008/11/10/obama-plans-to-undo-bush-rules-on-oil-drilling-on-public-lands-among-others/
December 4, 2008
Obama may reverse Bush policies on stem cells, drilling, abortion
http://www.cnn.com/2008/POLITICS/11/11/obama.executive.orders/index.html
Obama blocks offshore drilling Feb 11, 2009 ... Wednesday, February 11, 2009 ..
http://www.washingtontimes.com/news/2009/feb/11/drilling-ban-revisited/
That's not likely since it was first used for the coronary artey disease indication.
Colchicine: Lower doses for greater safety
The dosage advice for colchicine has been revised, coinciding with the introduction of a 0.5mg strength tablet. Colchicine is now indicated as second-line therapy for acute gout. For healthy adults the dosing interval has been increased to six hourly, with a maximum dose of 2.5mg in the first 24 hours and a maximum cumulative dose of 6mg over four days. In elderly patients, patients with renal or hepatic impairment, and patients weighing less than 50kg other treatments should be considered or lower doses of colchicine used. Patients should be warned of the symptoms of colchicine toxicity and advised to discontinue therapy immediately if they occur.
There's more info at the source.
Your doctor must not have paid attention in medical school.
The reason that gout usually occurs in the foot is that it is the coolest part of the body. Uric acid is poorly soluble in warm fluid and even less so as the temperature drops.
it’s used for gout, and has been around for a long time: it’s an herbal medicine.
But like all herbal medicines, the dosage for side effects is only slightly higher than the dosage that works. So if you get a poorly made generic medicine, you could get sick.
The “original” dosage was to take one tablet an hour, up to six doses or until either the gouty pain went away or you vomited/got diarrhea.
I read somewhere that the first American to take colchicine was Ben Franklin. It’s been used as a herbal for at least a thousand years. it does have narrow limits between enough and too much, but at low doses is pretty well tolerated. In Dermatology it’s used for certain types of vasculitis and a few other rashes for long term treatment. I tell people to start one pill/day and if not controlled and not having diarrhea to try working up to 2 or 3/day. Most tolerate one, some two and a few three pills/day. It doesn’t always work, but when it does it can spare patients from chronic prednisone therapy’s worse side effects.
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