Medical experts are seeking new label warnings for Focalin (dexmethylphenidate), a drug used to treat children with attention deficit hyperactivity disorder (ADHD), regarding possible occurrences of suicidal thoughts.
According to a Reuters report, several members of a U.S. Food & Drug Administration (FDA) advisory committee asked for the label change recently, citing eight reports of suicidal thoughts in children treated with Focalin over the past six years.
The FDA said it did in fact receive 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.
Focalin is a mild stimulant to the central nervous system, and a modified version of Ritalin. It is made by Swiss drugmaker Novartis AG. It is approved for children aged 6 or older.
“The suicidal ideation seems to be pretty serious,” said Dr. Sheldon Kaplan, panel member and chief of infectious diseases at Texas Children’s Hospital.
But the FDA said the risk of suicidal thoughts did not appear in clinical trials for Focalin, and the later reports were a tiny number compared to how many children used the drug.
“I’m somewhat puzzled by the focus of suicidal ideation,” said Tom Laughren, head of the FDA’s psychiatric products division, in response to the panel’s recommendation.
“These drugs are very widely used. And what you’re seeing here are a handful of reports that are difficult to interpret with regard to causality,” he said.
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, Fox News said.
This information is vitally important with the number of kids frequently being diagnosed with ADHD, a condition now affecting 3 to 5 per cent of kids globally.
The FDA said about 1.8 million children received prescriptions for Focalin or its generic versions from May 2005 to July 2011.
Children with ADHD are excessively restless, impulsive and easily distracted, and often have trouble at home and in school. There is no cure, but the symptoms can be kept in check by a combination of behavioral therapy and medication.
In the US, some 2.7 million people have prescriptions for ADHD drugs including Novartis’ Ritalin, Johnson & Johnson’s Concerta, Shire’s Adderall and Vyvanse and Eli Lilly’s Strattera.
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.
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.
It is not known at this point what the FDA will do with the recommendation. They often follow the advice of its committees, although it is not required to.
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