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January 23, 2009

Behavioral Side Effect Warning Issued on Singulair for Children

The following information is not provided as medical advice.  Families and youth should speak with their doctors and pharmacist about any concerns they have about medication.  Families and youth should seek a second opinion whenever they have a concern about the medical advice they are receiving from their treating physician.  

The Institute for Safe Medication Practices (ISMP) (Link to http://www.ismp.org/ ) has issued its latest report on complications from prescribed medications. ISMP, based in suburban Philadelphia, is the nation’s only 501c (3) nonprofit organization devoted entirely to medication error prevention and safe medication use. 

Excerpt from ISMP, QuarterWatch: January 15, 2009 on Montelukast  (SINGULAIR)

In the second quarter of 2008, there was "a sudden surge of reports of aggressive and suicidal behavior in children and adults taking the asthma drug montelukast (Singulair). In this period, Montelukast accounted for more possible cases of depression/suicidal behavior, hostility/aggression and psychosis than any other prescription drug. We believe this surge in reports was triggered by an FDA public notice in March 2008 that it was studying a possible link between montelukast and these psychiatric adverse effects. By alerting parents and patients to the possibility that these adverse effects could occur, the notice spurred large numbers of reports to the FDA and the drug’s manufacturer, Merck & Co."

Next Steps/ More Information

• MHAPA has submitted this information to Dr. Mary Diamond D.O., M.A., M.P.A, Medical Director, OMHSAS, who will be reviewing it at the next Behavioral Health Clinical Committee .
• The information on Singulair complications was submitted to PA Children’s News by Jenna Markle, Director, Parents United for Pharmaceutical Safety & Accountability. More on her organization and their concerns is at http://www.parentsforsafety.org/