Skip to comments.Asthma Drug Label to Include Psychiatric Risk
Posted on 07/21/2009 9:08:43 AM PDT by neverdem
The Food and Drug Administration last month called on manufacturers of leukotriene inhibitors to include safety precautions on their drug's labeling, because of reports of neuropsychiatric events in patients taking these drugs.
The FDA said the reported neuropsychiatric events included cases of agitation, aggression, anxiety, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal ideation and behavior, and tremor in patients using montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo, Zyflo CR).
Manufacturers of these drugs were asked to submit all available clinical trial data for these products for the safety review that concluded in April.
In its review, the FDA found that some reports included clinical details consistent with a drug-induced effect.
According to an FDA update from May, most of the reports of neuropsychiatric events were associated with montelukast, which is the most commonly prescribed drug that acts through the leukotriene pathway.
In the clinical trial data submitted by the manufacturers, neuropsychiatric events were not commonly observed, the FDA said. However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders [primarily insomnia] were reported more frequently with all three products compared to placebo.
The FDA advises that patients and health care providers be aware of the potential for neuropsychiatric events with these drugs used to treat asthma and symptoms of allergic rhinitis. The agency also suggests that physicians discontinue treatment if patients develop neuropsychiatric symptoms.
More information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm079523.htm.
Ok - now I have an excuse. Not ma fault.
Ping...(Not flu, but possibly of interest.)
thanks for posting, this is good to know, but this link came back “ page not found “ here,
is there another link?
Singulair = Merck
What is it with drugs from that company?
I have been on Singulair (for asthma) for about two years. I have had no problems. It is part of my treatment program that has improved my health (and lifestyle) considerably. My doc has discussed this warning (and counseled me...’having any depression issues?’) as this has been noted for awhile. My hope is that this class of med should just be monitored closer...that the benefits outweigh the risks. If they take me off Singulair, my next step would be a once a day inhaler (in addition to my rescue inhaler an allergy meds). Those inhalers have risks (sudden death!) as well.
I normally take one Singulair a day. Great stuff, really helps. However one time I took two by mistake. Yep, you will see colors and have the most interesting dreams.
Possible new tag ling: excuse me while I regain control over my agitation, aggression, anxiety, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal ideation and behavior, and tremor.
I’ve been taking Pulmicort for about 6 years and it has changed my life. My asthma symptoms have virtually disappeared. My allergist can’t get over the improvement in my lung capacity. No side effects.
Sounds fun, gotta try that one weekend when I’m not busy! Just kidding...I got off Singulair about two years ago and just use Advair now. Good stuff, I swim, bike, workout, etc.
This is a relatively rare adverse drug reaction. All drugs have them. Docs need to be able to recognize them.
IMHO, Vioxx was a bum rap. These patients probably had underlying coronary artery disease. If they were taking aspirin, they should have been taking it 1 - 2 hours before they took any Vioxx or any nonsteroidal anti-inflammatory drugs for pain. They interfere with aspirin's irreversible inhibition of platelet aggregation. They inhibit platelet aggregation but only reversibly. Platelets are formed elements of the blood that make up blood clots, in addition to proteins.
It's a bum URL. You'll have to search asthma at the FDA.
Page Last Updated: 07/21/2009
It’s almost halfway down the page.
thanks, one of my kids use to take singular, and i believe has had lasting affects from that stuff