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Author Topic: FDA is recalling "old drugs"
glassman
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this just came to my attention...

The Federal Food, Drug, and Cosmetic Act generally requires that drugs marketed in the United States be shown to be both safe and effective prior to marketing and widespread use in the general population. Drugs that are marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling.

However, for a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the United States without required FDA approval. Many healthcare providers are unaware of the unapproved status of some drugs and have continued to unknowingly prescribe unapproved drugs because the drugs’ labels do not disclose that they lack FDA approval. Often these drugs are advertised in reputable medical journals or are included in widely used pharmaceutical references such as the Physicians’ Desk Reference (PDR).


on the surface? this sounds like good policy...

however? the specific reason this was brought to my attention defies logic.. i won't go into details, other than to say they are "pulling" drugs that have worked for years and years.

one of the medications they are going after is Timed-Release Drug Products Containing Guaifenesin...

http://www.fda.gov/cder/drug/unapproved%5Fdrugs/guaifenesinQA%20.pdf

Guaifenesin is simply Tussin... you know? the stuff you can buy over the counter? like Robotussin? this is another example of the drug companies running the FDA...

the drug companies don't want you to get "cured" with the good old generic standby's, they need you to watch TV and buy what they are selling on the evening news...

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glassman
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The approved timed-release guaifenesin products are marketed over-the-counter, while many of the unapproved products are marketed by prescription only and are therefore covered by some health insurance plans. Why are the approved products available only over-the-counter?
When FDA approved the Adams timed-release guaifenesin products, the agency concluded that these products met the legal criteria for over-the-counter sale. These products can be used safely and effectively by consumers without the supervision of a health care practitioner, if the drugs are used as directed in the labeling. The FDA realizes that some consumers take unapproved prescription timed-release guaifenesin products that are covered by their health insurance, and that insurance reimbursement may no longer be available. The lack of reimbursement for these consumers is likely to be offset because the consumers will no longer need to pay to see a health care provider to get a prescription for these products.



does any of this make sense? [Confused]


a large part of this plan is that they are shutting down production of generics so your co-pays go up [Wink]

once a drug is approved by the FDA? a physician is SUPPOSED to be allowed to prescribe it as they see fit...
the rules were that the drug companies were not allowed to advertise the use of the drug for anything other than what they are approved for, but physicians were under no such limitation...

this must have changed recently?

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rimasco
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You gotta love the "legal DRUG PUSHERS"

Guy over here I knew loosley was addicted to vicoden and percocet... he hung himself the other day....36 yrs old. He O.D. a couple of times and then finally did himself in.

Same story of another guy few months back except the OD part did him in. over all I think I loosley knew about 5 guys that died from addiction to pain killers.

few months back a guy blew his head off on ouside the SI ferry.........Oxycodin.

You know theres a study out there with these stats. When are we gonna hear about them?

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glassman
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painkillers...

i was watching report the other day about Afghanistan and how they are now (since we invaded) the number one producer of opium in the world...

wasn't the Golden triangle in Nam the number one producer of opium when we invaded them too? [Wink]


where do the drug companies buy theirs? and who grows for them... i could be worng but i don't think they mix 'em up from scratch, i'm prety sure they derive them from botannicals...

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Stock, Ham, and Mayo Sandwich
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hmmm....maybe i should send back my Relpax - it gave me daily migraines....my doctor said it was all in my head - ya, no chit it was!!!!!!
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glassman
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funny you should bring up relpax, there's a series of drugs made from ergotamine, belladona and phenobarbitaol that are all being recalled right now too..
they are used for migraines and hot flashes.. they've been used successfully for about 40 years.. the makers of the new drugs like Maxalt and relpax don't want them around the anymore..

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NR
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http://www.fda.gov/cder/drug/unapproved%5Fdrugs/guaifenesinQA%20.pdf

quote:
The action includes products that contain only guaifenesin and those that contain guaifenesin combined with other active ingredients. Manufacturers must stop making these products on or after August 27, 2007, and stop shipping the products interstate on or after November 26, 2007. After these dates, only FDA-approved timed-released drug products containing guaifenesin my be manufactured and shipped interstate.
.....

quote:
This action does not affect the six FDA approved timed-release drug products containing guaifenesin. These six products are manufactured by Adams Respiratory Therapeutics, Inc., formerly known as Adams Laboratories, Inc."
Adams Respiratory Therapeutics, Inc.
ARXT:NAS
http://finance.yahoo.com/q?s=ARXT

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glassman
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they stoped shipping a bunch of others on the same dates too... several co's got sweetheart deals out of this...

it's even worse than awarding new patents to the same drug under a new name... claritin or one of it's compettitors did that years ago...

the timed release tussin is a popular prescription for fibromyalgia, which some doctors claim doesn't even exist....

sales of it have been going thru the roof since about 99, when some doc published a book claiming it to be a treatment for it....

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Don't envy the happiness of those who live in a fool's paradise.

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rimasco
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quote:
Originally posted by glassman:
painkillers...

i was watching report the other day about Afghanistan and how they are now (since we invaded) the number one producer of opium in the world...

wasn't the Golden triangle in Nam the number one producer of opium when we invaded them too? [Wink]


My friend was telling me the Queen of England was the biggest opium dealer in the world.....not sure what he meant.....but sounded like fun


where do the drug companies buy theirs? and who grows for them... i could be worng but i don't think they mix 'em up from scratch, i'm prety sure they derive them from botannicals...



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rimasco
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ooprs i got mixed in your quote

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glassman
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Bristol-Myers to pay $515m fine
Friday, 28 September 2007, 21:03 GMT 22:03 UK
US drugmaker Bristol-Myers Squibb and a subsidiary have agreed to pay more than $515m (£251.7m) to settle allegations of marketing certain drugs illegally.

The fines issued by the US Department of Justice mark the end of a probe into the firm's drug pricing practices that began a number of years ago.

The US DoJ concluded on Friday that the company and a wholly-owned subsidiary called Apothecon had used incentive schemes to encourage doctors and wholesalers to stockpile their drugs and so help Bristol-Myers achieve its sales targets.


Patients are entitled to unbiased decision-making from their physicians
Michael Sullivan
US attorney in Boston

This included maintaining "fraudulent and inflated" prices for a wide range of cancer and generic drugs knowing that federal health care programmes established reimbursement rates based on those prices.

Bristol-Myers was also accused of knowingly misreporting its best price for the anti-depression drug Serzone to Medicaid, the government-backed health insurance scheme.

In addition, the DoJ claimed that the company had promoted the use of the treatment-specific anti-psychotic drug Abilify to a wider client base than recommended by the Food and Drug Administration.


http://news.bbc.co.uk/1/hi/business/7019083.stm

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Don't envy the happiness of those who live in a fool's paradise.

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