ADHD

31 January 2012

Experts want suicide risk warning on ADHD drug

Parents of children who take Focalin (dexmethylphenidate) for attention deficit disorder should be warned about the risk of suicidal thoughts, US paediatric health advisers said.

0

Parents of children who take Focalin (dexmethylphenidate) for attention deficit disorder should be warned about the risk of suicidal thoughts, US paediatric health advisers said.

Several members of an advisory committee to the US Food and Drug Administration asked the agency to change the label for the commonly used drug, made by Swiss drug maker 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.

Number of ADHD kids is sky high

"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 number of children diagnosed with attention deficit hyperactivity disorder (ADHD) has skyrocketed in recent years, with the condition now affecting 3% to 5% of kids globally.

Changes to be made to Focalin’s label

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.

The advisory committee and FDA reviewers also recommended a change to Focalin's label to reflect the risk of anaphylaxis and angioedema.

Novartis said it 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.

(Anna Yukhananov, Reuters Health, January 2012) 

Read more:

Kids, ADHD and parents

Attention deficit hyperactivity disorder

 

Read Health24’s Comments Policy

Comment on this story
0 comments
Comments have been closed for this article.

Ask the Expert

ADHD Expert

Dr Renata Schoeman has been in full-time private practice as a general psychiatrist (child, adolescent and adult psychiatry) since 2008, currently based in Oude Westhof (Bellville). Renata also holds appointments as senior lecturer in Leadership (USB) and as a virtual faculty member of USB Executive Development’s Neuroleadership programme. She serves on the advisory boards of various pharmaceutical companies, as a director of the Psychiatric Management Group (PsychMG) and is the co-convenor of the South African Society of Psychiatrist (SASOP) special interest group for adult ADHD, and co-founder of the Goldilocks and The Bear Foundation (www.gb4adhd.co.za) She is passionate about corporate mental health awareness and uses her neuroscience background to assist leaders in equipping them to become balanced, healthy and dynamic leaders that take their own and their team’s emotional, intellectual, social health and physical needs into account. Renata is academically active and enjoys research and collaborative work, has published in many peer-reviewed journals, and has presented at local and international congresses. She is regularly invited to present at conferences and to engage with the media. During her post-graduate studies, she trained at Harvard, Boston in neurocognition and neuroimaging. Her awards include, amongst others, the Young Minds in Psychiatry award from the American Psychiatric Association, the Discovery Foundation Fellowship award, a Thuthuka award from the NRF, and a MRC Fellowship. She also received the Top MBA student award and the Director’s award from USB for 2015. She was a finalist for the Businesswomen’s Association of South Africa’s Businesswoman of the Year Award for 2016, and received the Excellence in Media Work award from SASOP during 2016.

Still have a question?

Get free advice from our panel of experts

The information provided does not constitute a diagnosis of your condition. You should consult a medical practitioner or other appropriate health care professional for a physical exmanication, diagnosis and formal advice. Health24 and the expert accept no responsibility or liability for any damage or personal harm you may suffer resulting from making use of this content.

* You must accept our condition

Forum Rules