FDA Bans another! This Time It's Anti-Nausea Drugs

[darkglobe]

This from New York Times:

F.D.A. Orders End to Production of a Form of Anti-Nausea Drug
By DONALD G. McNEIL Jr.
Published: April 7, 2007
The Food and Drug Administration yesterday ordered drug companies to stop making and selling anti-nausea suppositories containing a drug that the agency said did not work when used in that form.
The move was part of a campaign by the agency to re-evaluate drugs approved before 1962, the year drug makers had to start proving that their products worked. Before 1962, they had to prove only that they did no harm.
The suppositories, sold by prescription under the names Tigan, Tebamide, T-Gen, Trimazide and Trimethobenz, all contain the active ingredient trimethobenzamide.
About two million such suppositories are sold each year, said Dr. Jason Woo, an official in the agency’s compliance office.
Trimethobenzamide in other forms, including pills and injectables, does have F.D.A. approval for use against nausea and vomiting, the agency said.
The agency has had evidence since 1979 that trimethobenzamide suppositories do not work. But the review “requires a lengthy analysis,” Dr. Woo said. Also, the drug makers requested a hearing, “which further slowed the process,” he said.
Last June, the agency began “reinvigorating” the process, said Deborah M. Autor, the compliance office’s director.
Since then, it has removed its previous approvals of products containing quinine for leg cramps, ergotamine tartrate for migraines and carbinoxamine for children’s allergies and colds.
Although the agency estimates that less than 2 percent of prescription drugs sold now are unapproved, it believes there are “several hundred” unapproved active ingredients in prescription drugs.
Representatives of the companies making the suppositories could not be reached yesterday because of the holiday. The companies have until May 9 to comply with the F.D.A. order.

Okay, I know it's not particularly interesting or shocking, but it just goes to show how draconian the attitude of authority can be!

... it believes there are “several hundred” unapproved active ingredients in prescription drugs.

I find this quite interesting, though.

"reinvigorating"

Oh how agency euphemisms (sp?) amuse me...

[stoneinfocus]

The should test inahlers with corticosteroids for effectiveness -these don´t do shit, actually, and cause more sides than a low dose systemic corticosterone-regime, which def. is useful, but those inhalers are such a good deal, for an outfashioned, not anymore patented-protected reliable medication. ;-) .

I saw one study from a clinic, that did interstignly the follow up of sever asthmatic patients, on systemic steroids, firstly after the invetnion of the inhalers, who were to use inhalers now, .. the first follow up after 3(!) years!) was positive, but a few years later, they did another one, for whatever reason (observation/conscience?) concluding, that these inhalers don´t take care of the severity of asthma.

My asthma exacerbated and with inhalers I always had a sore throat, so that I could hardly speak and a funny little white candida in my pharynx, although I always flushed my mouth and ate/drank something big time because of the sides, because it really bothered me, besides that it didn´t seem to help much, it was just the sympathomimetics doing their job, which are as a smart move to betray your patient, always in this therapy included.

Then I saw a study comapring 100mg iv hydrocortisone compared with an 3000mcg of a high potent (30x hydrocort eq.) Corticosteroid, inhaled every hour, yielding a high systemic dose, just that htis time it was inhaled every hour, concluding that corticosteroids balbla , you get the picture.

You fall for the assumed "good wil to helpl" and ignore, resp. misinterprete changes in your condition, wasting years over years of your precious lifetime, just to recognize, that it´s just worsening and you´re in a condition far worse than it ever was or would have gotten with the old systemic regime in a low-high dose pattern, that now had to be upgraded to monster doses with all the sides to get the condition into control again, destroying my adrenal axis completely, so I´m just a living dead with no eneergy until I get my cort-pill and this supression is going to last more than a year, so to say it´s lifetime. :/

Just another example of the FDA and regulatory agencies how they just add to the imbalance of justice and equality and lack of the objective possibility of comparability for scheduling effects. -if it only did more good than bad, but with too many restrictions this is never going to happen.

But, hey, I only wnat my corticosteroids systemic, because you learn at the medical university, that corticosteroids make high and are _therefore_ demanded by trhe patient and in high dose, why the morons thuink onyl because og that. Since I do sport I´m "just want to be stonger in my sports" and doping.

Corticosteroids are def. no fun in the longer run (>6 weeks) if you don´t do anything to stop the sides (which docs won´t do, because they´re too lazy, or undereducated) and prevent receptor-downregulation, then you´re seriously in trouble and then find a doc, who will treat you accordingly, good luck! *lol*

[stoneinfocus]

So another new law that tends to worsen things for the liberty of choice,

maybe it works for another indication, that it´s not permitted for (extreme anal joy while putting it/it being put up in your arse), so the old law was better and not too narrow for no obvious reason -one can use enough internet-resources nowadays to inform oneself and trust knowledge and have one´s choice.