FDA OKs ADHD Treatment Patch for Kids
Daytrana Has Same Active Ingredient Found in Ritalin and Concerta
By Todd Zwillich
Reviewed By Brunilda Nazario, MD
on Thursday, April 06, 2006
April 6, 2006 – The FDA has approved the first skin patch for treating attention deficit hyperactivity disorder, despite ongoing debate about whether similar drugs should require stricter safety warnings.
The agency announced Thursday that it had approved Daytrana for use by children aged 6 to 12. The patch is manufactured by Noven Pharmaceuticals and Shire Pharmaceuticals.
Daytrana contains the active ingredient methylphenidate, the same stimulant drug used in popular oral medications such as Ritalin and Concerta.
Those drugs have recently been under scrutiny at the FDA. Two separate advisory committees have recommended stronger warnings for ADHD drugs because of reports suggesting that they may contribute to increased heart attack and stroke risk in adults and a danger of psychiatric side effects, including suicidal behaviors, in children.
Warnings of Side Effects
Daytrana’s label contains warnings of possible psychiatric side effects and alerts doctors not to prescribe it in children with structural heart abnormalities. Those warnings are common to all methylphenidate drugs.
But the advisory committees have recommended new warnings to make it clearer to doctors and patients that cardiovascular and psychiatric side effects can occur.
The agency is “actively considering” those recommendations but has not yet made a decision,” Thomas Laughren, MD, head of FDA’s division of psychiatric products, told reporters.
“There’s the standard language in labeling” for the patch, he said.
Shire spokesman Matthew Cabrey declined to disclose how many doctors are expected to prescribe the drug.
An FDA advisory panel of outside experts unanimously recommended Daytrana for approval in December.
The patch has been shown to reduce ADHD symptoms about as well as other oral treatments. But the FDA rejected the patch in 2003 because concerns over insomnia, tics, weight loss, and other side effects outweighed its benefits. New data presented by Shire and Noven Pharmaceuticals helped sway experts late last year.
SOURCES: Matthew Cabrey, spokesman, Shire Pharmaceuticals. Thomas Laughren, MD, director, FDA division of psychiatric drug products.