Posted by Abby on February 17, 2000, at 13:27:12
In reply to Re: FDA-Rebox. doesn't look too promising, posted by Leighwit on February 16, 2000, at 15:15:11
> I'm in the US and taking reboxetine through my Pdoc who orders it from a pharmacy in London. I consulted with a psychopharmacologist also before starting this drug.
>
> Drugs (at least those from the UK) without FDA involvement, have minimal labeling. You would not believe how vague the package insert is. Someone in the UK on reboxetine commented on another ng about how sophomoric the labeling information is on all of their drugs. "Pathetic" was the term I believe he used.
>
> I'm not defending the slow approval process by any means. But I do have a new appreciation for the information the FDA requires the pharmaceutical companies to provide to the public.
>
> I have juvenile-onset (Type I) insulin-dependent diabetes. The contraindications for ADs matter a great deal to all of us; particularly those with chronic medical conditions.
>
> If I lived in the UK, I'd be researching FDA information to make safe choices.
>
> Just some thoughts about the flip side of the coin.
>
> LWUK labeling is rather patronizing and simplistic. I was on Lustral for a while, their name for Zoloft. I don't think that Europeans, and certainly not Britons, are any easier on drug manufacturers on truly substantive matters. We have i-dotting and t-crossing obsessed bureaucrats.
The UK has problems too. The chairman of Glaxo-Wellcome was threatening to abandon clinical trials and early launches there--too much work for the size of the market. To illustrate my point that the way we are harder on pharmaceutical firms is only so much paperwork production and not true safety concerns, I'll mention a drug which is approved for use here but not in the UK--bupropion (Wellbutrin).
A fair number of psychiatrists disagreed, but the UK regulatory body believed that the risk of seizure was too great. In that particular case, given the same data, they were "tougher" than our beloved FDA.Abby
poster:Abby
thread:21540
URL: http://www.dr-bob.org/babble/20000209/msgs/22055.html