According to reports from both the US and, more recently, Canada, the popular asthma drug Singulair (montelukast sodium) is being blamed for patients using it experiencing depression and suicidal urges. The Federal Drug Administration had begun investigating the supposed link between depression, hostility and suicide attempts and this medication since at least March 2008. Merck, the manufacturer, had previously added to the patient information (which is normally included in packages of the drug) that possible adverse effects include tremor (added in March 2007), depression (added April 2007), suicidality (added October 2007), and anxiousness (February 2008). Singulair, which is used to treat both asthma and allergic rhinitis (nasal allergies) is a leukotriene receptor antagonist. In this class of drugs there are other medications as well, namely Accolate (zafirlukast, made by AstroZeneca), Zyflo and Zyflo CR (both zileuton, from Cornerstone Therapeutics) that are also linked to risks of depression. As of June of this year, the FDA mandated that manufacturers of those three drugs as well as Singulair have to label their packaging with warnings about the possible dangers of their use.
It is strange, however, that in January of this year, the FDA issued a statement that they found no link between montelukast sodium and any suicide attempts or depression, following their study since the previous year. What could have induced such a complete reversal in such a short time frame? By this past April, the FDA had concluded their study of the asthma drugs and apparently found evidence from reports of a lengthy list of neuropsychiatric effects. These included agitation, aggression, anxiousness, dream abnormalities, hallucinations, depression, insomnia, irritability, restlessness, suicide, thoughts of suicide, and tremors. These symptoms' reports, which came partially from consumers' reports as well as from their own study, were so numerous that they could not be ignored.
This incident proves more than what was found about these particular drugs; it shows that patients are also consumers with the power to make changes. Reporting of adverse symptoms to medical professionals and to the manufacturers directly CAN make a difference that will result in action by the federal government. To report any problems with medication, see the following links:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm
http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
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