Posted by Tomatheus on August 26, 2006, at 12:46:29
In reply to Re: Caffeine/Coffee, posted by jealibeanz on August 26, 2006, at 1:58:52
Jealibeanz,
I was also quite surprised by the FDA's decision. As you pointed out, Cephalon representatives have argued that the child who reportedly experienced symptoms of Stevens Johnson syndrome while taking Sparlon did not develop the syndrome because of the drug. In fact, it appears that it's questionable as to whether or not the actual syndrome even developed in the child at all. The company seems to be saying that it was *suspected* that the child may have developed Stevens Johnson syndrome (probably because he/she experienced symptoms that could have potentially been explained by the syndrome), but that it ultimately turned out that he/she did not actually develop the syndrome.
I don't know a whole lot about modafinil (the active ingredient in both Provigil and Sparlon), but based on the limited amount of information that I've come across concerning the drug, it seems to me that its safety profile would be rather favorable in comparison to that of stimulants like Ritalin and Adderall. I do find it encouraging that the FDA seems to be exercising more caution in approving medications for pediatric use than they used to, but I think the agency may have gone too far in this case. If anything, modafinil seems to be less likely to produce adverse effects than the stimulants, so I question whether the FDA's decision to reject Sparlon was truly based on safety concerns. As I understand it, numerous FDA officials have been accused of having ties with certain pharmaceutical companies. I wonder to what extent the FDA's decision on Sparlon might have been influenced by political pressure from Shire (the manufacturer of Adderall) and/or Novartis (the manufacturer of Ritalin) -- companies that clearly would have regarded Sparlon as another competitor in the ADHD drug market. As far as I know, there isn't any convincing evidence to support the idea that the FDA's decision was politically driven, but honestly, I wouldn't be suprised if that turned out to be the case.
Tomatheus
> Thanks for the link. I had found some articles on this. I'm very surprised. It's not even a new drug, just being approved for a new use. It's not a true stimulant. One would think the FDA would like that idea since children are going to be medicated for ADHD in some form no matter what. Now they'll just have to stick to Adderall, Ritalin, Concerta, etc, which many consider dangerous.
>
> The company even commented that the one child more likely did not develop Steven Johnson Syndrome because of Sparlon. Yet, they don't appear to have fought had to push it through and don't seem to be all that adament about getting it reviewed again anytime in the near future. It's so difficult to run trials on children. The FDA seems to be using extra caution with pediatric approved drugs (i.e. blackbox warnings on AD's). They must be frustrated.
poster:Tomatheus
thread:672370
URL: http://www.dr-bob.org/babble/20060825/msgs/680269.html