News January 31, 2012
Children who take a common drug for attention deficit disorder should be warned about the risk of suicidal thoughts, U.S. pediatric health advisers said on Monday.
Several members of an advisory committee to the Food and Drug Administration asked the agency to change the label for Focalin, an attention deficit medicine made by Swiss drugmaker Novartis AG, to reflect this risk. The drug is approved for children aged 6 or older.
The FDA often follows the advice of its committees, although it is not required to.
The FDA said it received eight reports of suicidal thoughts for children or adolescents who took the drug over the past six years, and four of the cases appeared to be linked to the medicine. The link for the remaining cases was less clear.
"The suicidal ideation seems to be pretty serious," said Dr. Sheldon Kaplan, panel member and chief of infectious diseases at Texas Children's Hospital.
Read more: http://www.foxnews.com/health/2012/...cide-risk-warning-on-adhd-drug/#ixzz1l6EpYMV9
Children who take a common drug for attention deficit disorder should be warned about the risk of suicidal thoughts, U.S. pediatric health advisers said on Monday.
Several members of an advisory committee to the Food and Drug Administration asked the agency to change the label for Focalin, an attention deficit medicine made by Swiss drugmaker Novartis AG, to reflect this risk. The drug is approved for children aged 6 or older.
The FDA often follows the advice of its committees, although it is not required to.
The FDA said it received eight reports of suicidal thoughts for children or adolescents who took the drug over the past six years, and four of the cases appeared to be linked to the medicine. The link for the remaining cases was less clear.
"The suicidal ideation seems to be pretty serious," said Dr. Sheldon Kaplan, panel member and chief of infectious diseases at Texas Children's Hospital.
Read more: http://www.foxnews.com/health/2012/...cide-risk-warning-on-adhd-drug/#ixzz1l6EpYMV9