Published January 31, 2012
Reuters
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
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.
In the United States, some 2.7 million people have prescriptions for ADHD drugs including Novartis' Ritalin
Some patient advocates say doctors and parents may be too quick to diagnose kids with the condition, and the drugs may cause side effects that can damage children's health.
The FDA said about 1.8 million children received prescriptions for Focalin or its generic versions from May 2005 to July 2011.
The label for Focalin already warns patients that they may have new psychotic or manic symptoms after taking the drug, but does not mention suicidal thoughts.
Out of other ADHD drugs, only Strattera's label mentions thoughts of suicide as a side effect, as part of a restrictive "black box" warning.
The FDA monitors reports of side effects from medicines after they've been approved in order to discover potential safety problems. For drugs that are used by children, the agency must hold regular advisory meetings to review their safety.
The advisory committee and FDA reviewers also recommended a change to Focalin's label to reflect the risk of anaphylaxis, an allergic reaction, and angioedema, a type of swelling beneath the skin.
Novartis said it is will make any necessary changes to Focalin's label after discussing them with the FDA.
"Novartis is committed to patient safety and will continue to work closely with the FDA as the agency completes its review," said Brandi Robinson, spokeswoman for the company.
Reuters
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
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.
In the United States, some 2.7 million people have prescriptions for ADHD drugs including Novartis' Ritalin
Some patient advocates say doctors and parents may be too quick to diagnose kids with the condition, and the drugs may cause side effects that can damage children's health.
The FDA said about 1.8 million children received prescriptions for Focalin or its generic versions from May 2005 to July 2011.
The label for Focalin already warns patients that they may have new psychotic or manic symptoms after taking the drug, but does not mention suicidal thoughts.
Out of other ADHD drugs, only Strattera's label mentions thoughts of suicide as a side effect, as part of a restrictive "black box" warning.
The FDA monitors reports of side effects from medicines after they've been approved in order to discover potential safety problems. For drugs that are used by children, the agency must hold regular advisory meetings to review their safety.
The advisory committee and FDA reviewers also recommended a change to Focalin's label to reflect the risk of anaphylaxis, an allergic reaction, and angioedema, a type of swelling beneath the skin.
Novartis said it is will make any necessary changes to Focalin's label after discussing them with the FDA.
"Novartis is committed to patient safety and will continue to work closely with the FDA as the agency completes its review," said Brandi Robinson, spokeswoman for the company.