Thought folks might appreciate this bit of news [was in the Wall Street Journal] Thursday March 23, 4:38 PM ESTWASHINGTON - (Dow Jones)- A Food and Drug Administration panel rejected a proposed drug by Cephalon Inc. (CEPH) to treat children and adolescents with attention deficit hyperactivity disorder on concerns the drug might be linked to a potentially fatal skin condition.
The outside panel of medical experts said that while it believed the drug would be effective at treating ADHD, it simply didn't have enough data on whether the drug could cause Steven Johnson's Syndrome, a severe skin rash that can be fatal.
The proposed drug, Sparlon, is already on the market and is sold at a lower dose to treat sleep disorders under the brand name Provigil.
The panel voted 12 to 1 against the drug as a treatment for ADHD in children and adolescents. The panel suggested Cephalon (CEPH), based in Frazer, Pa., conduct additional studies of the drug to see if any new cases of Steven Johnson's Syndrome or SJS occur.
THANKS TO: Stefan Kruszewski |
Labels: drug wars, FDA