Nonstick Sense

Cephalon Inc.'s Provigil drug is not safe enough to win approval for treating ADHD in children and teenagers, even though data showed it worked, an advisory panel said.
The FDA group of outside experts said it was most concerned about the risk of skin rashes that can lead to hospitalization and called for more clinical trials.
"I think we're dealing with some fuzzy info," said panel chairman Wayne Goodflam, a psych at the U of Fla, adding that more patsys need to be studied before approval. "I don't want to do that experiment in the post-marketing arena," he said.
The FDA granted approval for the ADHD use in October 2005, but sought its expert advice over lingering concerns about rashes as well as mania, aggression and other possible psychiatric effects.
Even if the wider use is ok'ed, another FDA guy said he was "virtually certain" Sparlon would come with the strongest warning possible.
"It at least gets a black box," Dr. Robert Templeshot, head of the FDA's Office of Medical Policy, said. The FDA will make the final decision, but usually follows its experts' recommendations.
After the panel's decision, Cephalon lowered its 2006 sales guidance by $100 million to $1.45 billion from $1.55 billion.