FDA Panel Backs Approval of ADHD Patch
Experts Recommend That Daytrana Should Be Used By Kids Who Can't Take Pills
Allergic Reaction Concerns
Levin and other FDA officials said they were still concerned about results showing that the patch may cause sensitivity reactions that could make patients unable to take any methylphenidate drug.
About half of children who used the patch in clinical trials experienced skin reactions. Most of the reactions were mild, but at least one of 270 had an allergic response that made it unsafe to take any other methylphenidate drug.
Experts expressed concerned that the risk of allergic reactions -- which remains largely unknown -- could cause large numbers of permanent allergies to a drug taken by millions of American children.
Panelists unanimously urged the FDA to require the companies to study the risk of allergic skin reactions once Daytrana reaches the market and to urge doctors to reserve it only for children who can't or won't take pills.
"I'm not comfortable going on the record as it being first-line therapy," said Barbara G. Wells, dean of the University of Mississippi School of Pharmacy and a panel member.
Thirteen percent of children in a company study experienced insomnia using the patch, compared to 8% who took the competitor drug Concerta in pill form. Children taking the drug lost an average of 2.2 pounds after seven weeks of using the patch.
Shire spokesman Matthew P. Cabrey said the company was likely to advertise Daytrana directly to consumers if it gains FDA approval.