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 veggie
Registered: 07/25/04
Posts: 13,985
Loc: 
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 FDA warns 20 makers of unapproved migraine treatments 
#6625551 - 03/01/07 05:39 PM (5 years, 2 months ago) |
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March 1, 2007 - signonsandiego.com
FDA warns 20 makers of unapproved migraine treatments
WASHINGTON – The government said Thursday it had warned the world's largest maker of generic drugs and 19 other companies that they are illegally selling migraine medicines without federal approval.
The Food and Drug Administration said the 20 warning letters were part of an effort to halt the marketing of unapproved and potentially dangerous drugs. The goal is to get the unapproved drugs off the market, agency officials said. The manufacturers could seek agency approval for the products.
The prescription migraine treatments contain a drug called ergotamine tartrate. Ergotamine is derived from a rye fungus called ergot, from which a separate drug, the illegal hallucinogen LSD, also can be synthesized. Ergotamine is a vasoconstricting drug, meaning it narrows the blood vessels when taken.
The letters – dated Monday but not publicly disclosed until Thursday – went to companies that include a U.S. subsidiary of Israel's Teva Pharmaceutical Industries Ltd., the world's largest generics manufacturer. Other recipients included Iceland's Actavis and Sandoz Inc., a pioneer in the marketing of ergotamine tartrate that is now part of Switzerland's Novartis AG.
Messages left with all three companies were not immediately returned Thursday.
The FDA said the companies have 60 days to stop making the drugs and 180 days to stop distributing them. Otherwise, the companies are subject to seizure or injunction, the FDA said.
“Because these drugs don't have approval, we don't know how they were formulated or manufactured. We don't know if they are safe or effective,” Deborah Autor, director of the office of compliance within the FDA's Center for Drug Evaluation and Research, told reporters.
The FDA said the labels of the drugs failed to warn consumers of dangerous interactions if taken with other medications, including some HIV drugs, antibiotics and anti-fungal agents.
There are five ergotamine tartrate drugs on the market that have FDA approval, including one made by Sandoz. The labels of those approved medications carry “black-box” warnings, the most severe the government can require, about the risk of drug interactions.
The FDA stepped up last year its efforts to get drugs without agency approval off the market. Under guidelines issued in June, the FDA said those unapproved drugs most likely to pose a risk to public health would be the highest priority for enforcement action.
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SuperD
Lophophiend
Registered: 10/05/03
Posts: 5,186
Loc: My stash box
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Re: FDA warns 20 makers of unapproved migraine treatments [Re: veggie]
#6625655 - 03/01/07 06:06 PM (5 years, 2 months ago) |
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<<The prescription migraine treatments contain a drug called ergotamine tartrate. Ergotamine is derived from a rye fungus called ergot, from which a separate drug, the illegal hallucinogen LSD, also can be synthesized.>>
I can picture it now, LSD cooks everywhere raiding Wal-Mart at 2am to purchase 30 boxes of medicine containing ET. With the meth cooks coming in right behind them for the Sudafed. 
--------------------
I'd like you to meet my local drug dealer 
Bruce Campbell for a day! said: Go misidentify a mushroom please.
I'm a psilovibin' psilocybeing 
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 rawtoxic
Stranger
Registered: 10/06/02
Posts: 2,097
Loc: smokey mountains
Last seen: 1 year, 9 months
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Re: FDA warns 20 makers of unapproved migraine treatments [Re: SuperD]
#6625723 - 03/01/07 06:28 PM (5 years, 2 months ago) |
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I don't trust the FDA for shit anyways.
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dedjam
Electro Penguin
Registered: 12/14/05
Posts: 2,139
Loc: Moralton, Statesota
Last seen: 1 year, 5 days
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Re: FDA warns 20 makers of unapproved migraine treatments [Re: rawtoxic]
#6627226 - 03/02/07 06:15 AM (5 years, 2 months ago) |
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wait wait wait....there are FDA approved drugs with ET in them? I thought that shit was completely banned in this country? What pills, and where can I get them, and do I have to sign a log? lol...
....um because i have a headache...
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demius
broccolilocks
Registered: 08/18/05
Posts: 36,556
Loc: the popcorn stadium
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Re: FDA warns 20 makers of unapproved migraine treatments [Re: veggie]
#6627275 - 03/02/07 06:52 AM (5 years, 2 months ago) |
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well, I'd love to know the names of these OTC meds, just for the hell of it
But, you'd have to buy tons of these pills to be able to synth. any sizable amount of LSD, plus you'd still have to have all the lab equipment and chem knowledge
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dedjam
Electro Penguin
Registered: 12/14/05
Posts: 2,139
Loc: Moralton, Statesota
Last seen: 1 year, 5 days
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Re: FDA warns 20 makers of unapproved migraine treatments [Re: demius]
#6627296 - 03/02/07 07:01 AM (5 years, 2 months ago) |
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Quote:
demius said:
well, I'd love to know the names of these OTC meds, just for the hell of it
But, you'd have to buy tons of these pills to be able to synth. any sizable amount of LSD, plus you'd still have to have all the lab equipment and chem knowledge
The only difficult part I see here, for me...would be obtaining the necessary amount of ET, which if bought over the course of a few years wouldnt amount to much of a task. Im not seriously considering it, hell Id just like some good ET medicine for the migraines I get.
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