5 ms·
Beware, there is a 2 in 933 chance of developing a severe skin rash reaction, and the FDA has rejected modafinil for this reason. From Wikipedia: "The FDA advi
by dj_axl 15y ago
Beware, there is a 2 in 933 chance of developing a severe skin rash reaction, and the FDA has rejected modafinil for this reason. From Wikipedia:
"The FDA advisory committee voted 12 to 1 against approval, citing concerns about a number of reported cases of skin rash reactions in a trial that included 933 patients on modafinil, including two severe cases which appeared to be "definite" erythema multiforme or Stevens–Johnson syndrome. One of the two severe cases involved hospitalization."
- georgieporgie 15y agoThat was in a trial for ADHD treatment in adolescents. As a result, they don't advise the use of Modafinil in children. It is unclear to me whether the 933 studied were adolescents, and if so, whether or not a similar rate of rashes are seen in adults. The Wikipedia page also says: "From the date of initial marketing, December 1998, to January 30, 2007, FDA received six cases of severe cutaneous adverse reactions associated with modafinil, including erythema multiforme (EM), Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) involving adult and pediatric patients. I have to admit, six cases in eight years doesn't strike fear into me.
- gwern 15y agoThose six cases cover somewhere upwards of 700,000 patient-years; the final estimate I found was that the risk roughly doubled from 3 SJS cases per million people to 6 cases per million people in modafinil users. (None were fatal, incidentally.)
- mvzink 15y agoGiven that they are all different conditions, I'm guessing it's more likely to be reactions with other drugs, diet, conditions, etc. than a side effect worth worrying about.