Accolate, Zafirlukast News

Lynne Faraone created this wall of inspiration in her Mentor home. She says hope especially helped her as she fought for a warning label on the asthma and allergy medication Singulair.

Reports of neuropsychiatric adverse effects from leukotriene modifiers have prompted the FDA to request label changes for these drugs.

This roundup includes the following brief clinical practice updates: The FDA is warning consumers to stop using three Zicam intranasal products.

The FDA has requested that warnings of mood changes and suicidal behavior be placed on the label of Singulair, which is also facing challenges over the validity of its patent.

The FDA's new requirement for tighter warnings on a range of asthma drugs will not come as a surprise to Dr.

The U.S. Food and Drug Administration provided further updated safety information on a class of asthma drugs known as leukotriene modifiers.

Leukotriene Inhibitors: Montelukast , Zafirlukast , and Zileuton June 12, 2009 Audience: Pulmonology healthcare professionals FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communication about the ongoing safety review for the leukotriene inhibitors, ...

The U.S. Food and Drug Administration on Friday requested that the makers of a class of asthma drugs called leukotriene receptor agonists place a "precaution" on the drugs' labeling, warning of the potential for neuropsychiatric events.

Kids with severe asthma can breathe a lot easier than they could a decade ago. Thanks in large part to better medications , children with severe asthma are less likely to wheeze and suffer full-blown asthma ...

Post marketing reports via MedWatch suggest a link berween Singulair and possibly the two other approved drugs which act on the leukotriene pathway .

FDA is continuing to study the potential mood and behavioral adverse events linked with drugs that influence the leukotriene pathway, such as montelukast, zafirlukast, and zileuton.

The U.S. Food and Drug Administration said a safety review has yet to find conclusive evidence of any link between certain asthma drugs and suicide.

On March 27, 2008, FDA announced that it was reviewing safety data that raised concerns about a possible association between the use of montelukast and behavior/mood changes, suicidality and suicide.

U.S. regulators on Tuesday said their review of clinical trials does not suggest Merck & Co's Singulair asthma drug or similar medicines cause suicide or suicidal thought, although the data were inadequate to ...