By Miranda Hitti WebMD Medical News
Reviewed By Louise Chang, MD on Friday, March 31, 2006
March 31, 2006 — The FDA has approved Prograf, a drug that suppresses the body’s immune reaction, to prevent graft rejection in heart transplant recipients.
Prograf capsules and Prograf for injection — the first products approved in the U.S. for heart transplantation in eight years — had been previously approved to prevent graft rejection in liver and kidney transplant recipients.
“This approval is another example of the benefits of our agency’s ‘orphan’ drugs program, which seeks to answer the medical needs of small groups of patients,” says the FDA’s Steven Galson, MD, MPH, in a news release. Galson directs the FDA’s Center for Drug Evaluation and Research.
“The doctors who perform approximately 2,200 heart transplants in the U.S. each year will now have a new option for enhancing successful outcomes by preventing the rejection of the grafted organs,” Galson says.
Daytrana Has Same Active Ingredient Found in Ritalin and Concerta
By Todd Zwillich WebMD Medical News
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.