rosacea] Re: We got bashed

[Guest guest]

> How then does the FDA explain Phen-Phen?? I think the FDA is an

atypical

> government agency. They allow a dangerous diet drug on the market

and hassle

> OTC's about wording on the labels of their products??

Woody, the FDA explains Fen-Phen on

http://www.fda.gov/cder/news/feninfo.htm

That's an example of a dangerous side effect that become known after

the approval process, at which time the drugs' approval were

withdrawn. That's why many physicians (like myself) avoid prescribing

any new drug or procedure until in common use for two years. The

FDA's review process is good for efficacy (how well a drug works) and

obvious safety, but less successful for subtle aspects of safety,

such as those with small but deadly incidences or that take

years/decades to manifest over longterm use.

The FDA explains it's " risks vs. benefits " approval process for

drugs. (Scroll down to the end of the page for OTCs):

http://www.fda.gov/fdac/special/newdrug/benefits.html

Taken from that page: " In the final analysis, FDA's decision whether

to approve a new drug for marketing boils down to two questions:

-Do the results of well-controlled studies provide substantial

evidence of effectiveness?

-Do the results show the product is safe under the conditions of use

in the proposed labeling? Safe, in this context, means that the

benefits of the drug appear to outweigh its risks. "

Marjorie

Marjorie Lazoff, MD

>

>

> For FDA-approved prescriptives, I thought the key was demonstrating

> that an ingredient is more effective than placebo in treating a

> condition. A safety profile must be filed, and the FDA will not

> approve (or will recall) something that is shown to be dangerous,

but

> a drug doesn't need to be safe to be approved -- just efficacious.