What’s the connection?
On Monday, January 30, 2012, pediatric health advisers acting as an advisory committee to the Food and Drug Administration requested that a special warning be placed on the label of a common stimulant medication used to treat attention deficit disorder.
The drug is Focalin and produced by Swiss drug maker Novartis. The FDA has approved Focalin for children aged 6 or older. However, Focalin is often prescribed off-label meaning even younger children may be prescribed the medication.
The advisory committee is responding to reports the FDA received over the past six years in which eight reports of suicidal thoughts for children or adolescents who took the drug were documented. Only four of the eight cases could be linked to Focalin. Links to Focalin in the remaining cases remain subject to further scrutiny.
The FDA monitors reports of side effects (often reported from the drug manufacturers themselves) from FDA approved drugs to discover potential side effects or health risks. To this end, the FDA holds regular advisory meetings to review drug safety for medications used by children.
The FDA typically tries to balance the vast number of Focalin users with the number of children reporting suicidal thoughts. The FDA noted that reports were miniscule compared to how many children used the drug. A staggering 1.8 million children received prescriptions for Focalin or its generic versions from May 2005 to July 2011 with only eight reported cases of suicidal thoughts. The FDA also stated the risk of suicidal thoughts did not appear in clinical trials for Focalin.
The Focalin website (http://www.focalinxr.com/info/about-focalinxr.jsp) warns patients that they may have new psychotic or manic symptoms after taking the drug, and requests the patient confer with his doctor if they have a history of suicide, bipolar disorder, or depression.
The FDA often follows the advice of its committees, although it is not required to do so.
“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.