FDA Warns Migraine Medicine Makers

[Guest guest]

FDA Warns Migraine Medicine Makers

By ANDREW BRIDGES, Associated Press Writer

San Francisco Chronicle - San Francisco,CA

Thursday, March 1, 2007

(03-01) 17:03 PST WASHINGTON, (AP) --

http://www.sfgate.com/cgi-bin/article.cgi?

f=/n/a/2007/03/01/national/w140336S69.DTL

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.

___

On the Net:

Food and Drug Administration warning letters:

www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm

[Guest guest]

This is perhaps a pessimistic view of this situation but Caffergot

was an inexpensive 'refuge' for migraine sufferers like myself from

the very expensive new, and not any safer vasoconstrictors like

immitrex. Due to the fact that it has considerable caffeine in

product, I could not take it in the afternoon or evening but could

take it for an early morning migraine and 'was' very cheap. Last

time I filled an Rx for it, I could only get the more expensive

brand name product, original maker of it. *No generics were

available. It is hard to believe that not ONE generic maker of

product would seek approval from FDA but perhaps not been 'okayed'

yet, delayed in red tape. The new migraine medicines are just as

dangerous but extremely expensive due to still being under patent.

I don't really think it is due to FDA being concerned about consumer

health <<<laugh>>>. Since when did they start to be concerned???

There are tons of medicines out there that should be taken off the

market but are too profitable so no action is taken until a class

action suit forces them off.

That said, I know after info put here to be cautious of egots, but I

can't get them anymore anyway. I used to be able to get 100 tablets

for less than the price of 6 newer migraine medicines. Now I can't

get them at all. I have found some healthier way to deal with

migraines but sometimes nothing will work and so I do take these

vasodilators but there is considerable risk of heart attack, etc

with them.

<http://www.fda.gov/cder/drug/advisory/SSRI_SS200607.htm>

--- In , " tigerpaw2c " <tigerpaw2c@...>

wrote:

>

> FDA Warns Migraine Medicine Makers

>