FDA flags psychiatric risks of asthma drugs -- especially singulair

[steven johnson]

Almost every medication has a side effect list of a dozen or more potential problems. Looks like the FDA is jumping on the adverse reports earlies than they did with Vioxx.

Associated Press
3:23 PM PDT, June 12, 2009


WASHINGTON -- New labels on popular asthma drugs like Merck's Singulair must highlight language about suicidal behavior, depression and anxiety seen in a small number of patients, federal regulators said today. After 15 months of investigation, the Food and Drug Administration said Merck & Co. Inc., AstraZeneca and Cornerstone Therapeutics will have to raise label warnings about psychiatric problems reported by a handful of patients taking their drugs.

"Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications," the FDA said in a posting to its Web site.

"FDA regulators last spring began reviewing a handful of reports about mood changes, suicidal behavior and suicide in patients who had taken Singulair. The agency also launched probes into other drugs in the class, including AstraZeneca PLC's Accolate and Cornerstone Therapeutics Inc.'s Zyflo.

The exact language of the labeling updates has not been released, but the FDA said it could mention a slew of psychiatric problems, including: "agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior -- including suicide -- and tremors."


http://www.latimes.com/business/la-fi-asthma13-2009jun13,0,2225818.story">FDA flags psychiatric risks of asthma drugs

[bkkyosemite]

1. I took it but not on a regular basis. But I kept getting fast heartrate for no reason.

Finally after a year I was again in my heart doctors office and said why don't you know why I am getting Tachycardia. He said I don't know. Then he started recording his findings to my Internal Med doctor on his recorder as I listened while looking out his window (he had a wonderful view of the Sierra's). He was stating his findings then started stating what meds I have taken and all of a sudden I heard the click of the recorder button as he lifted his finger off of it. He had just said she takes occasionally Singulair. I said Jim damnit don't tell me another side effect of a drug. He said in some people it could cause this. It was so bad one time I lay on the floor waiting for the ambulance to arrive. The damn pharma companies need to pay for all those damn medical bills that were caused by their crappy meds.