View Full Version : MODAFANIL warning issued (reactions)

12-21-07, 08:01 PM

12-25-07, 07:26 PM
Was that ever surprising? FDA decided not to approve it for ADD due to exactly the same reason-- Stevens-Johnson Syndrome.

12-30-07, 10:51 PM
I'm glad that ppl are being made aware of a rare, but serious and potentially fatal side effect. I think that warnings are good, but the way that article reads is extreme Every single effect mentioned in that article was a side effect ("can cause hallucinations, depression, etc."). So can the stimulants and some antidepressants; that doesn't mean these drugs don't help people.

Stevens-Johnsons syndrome is associated with certain antibiotics as well, but no one is as up in arms about that

03-13-08, 09:45 AM
Actually, the original SJS report may have been spurious, from updates I've read recently. There was one case of a severe skin rash in one child during the trials used for assessment by the FDA, and there is now doubt that it actually was SJS, or that it was a related to the modafinil treatment at all.

Nevertheless, the approval for using modafinil in children was rejected at the time on the basis of the evidence presented to the FDA, and Cephalon (the maker of Provigil brand modafinil) would have to put in a new submission with data from new trials to get approval reconsidered, which they haven't done so far AFAIK.

Regulatory agencies in several other countries have followed the FDA lead on not approving modafinil for children, based on the results of the original submission, as I understand it.

Modafinil in adult trials have suggested that is is actually a very safe drug, non-addictive and with few (and relatively mild) side effects compared to many psychtropics. By some reports, it's now regularly being used (abused?) by many healthy university students and academics as a general "cognitive ehancer" -- sort of a 21st century benzedrine.

A pity if a useful tool as been omitted from the toolkit on the basis of some noisy data. But that's the nature of statistical analysis -- it can never you absolutely "yes" or "no", only "probably yes" or "probably no" (with well defined measures of probability.)

03-13-08, 06:51 PM
It would be good to know what percentage of people experience side effects. Probably only a small percentage but some of the side effects, (hallucinations?!) seem extreme.