How do you want your Singulair be delivered? Choose here!

The Food and Drug Administration has issued an “early communication” to health care professionals regarding its review of the postmarketing reports it has received of behavior/mood changes, suicidality, and suicide in patients who have taken the asthma and allergy medication montelukast (Singulair).
At press time, the agency had declined to say how many reports of this kind it had received.
Dr. George Philip, senior director of clinical research at Merck & Co., which makes Singulair, also said the company would not reveal any more specific data at this time.
“We think that sharing those numbers is ultimately not very useful,” Dr. Philip said in an interview.

Related Results

SingulairSingulair labelSingulair Sales.Singulair, veramyst nasal sprayNew Singulair aerator

An FDA spokeswoman said the agency had received reports of three or four suicides in patients taking Singulair. But no causal relationship has been established, she noted.
Merck agreed that reports did not necessarily signal a relationship. “The fact that an adverse event has been reported to Merck and to regulatory agencies does not reflect a conclusion that the posmarketing event is caused by Singulair,” the company said in a statement.
The company picked up a signal of potential psychiatric adverse events throughanecdotal reports submitted to Merck over the last year or so as part of routine postmarketing surveillance, Dr. Philip said.
Merck updated Singular’s label in October 2007 to reflect a potential association with suicidality. In the past year, Merck has also added information that the leukotriene receptor antagonist has been associated with tremor, depression, and anxiousness.
FDA and Merck officials met in February to discuss how best to communicate the label changes to physicians, patients, and others, Dr. Philip said. Merck already had been–and will continue–communicating directly with physicians through face-to-face meetings.
An initial review of clinical trial data found no evidence of an association with mood changes, according to Dr. Philip. “In a cumulative analysis recently provided to the FDA of Merck’s randomized, double blind, place-bo-controlled clinical trials, which included over 11,000 adults and children in over 40 studies who were treated with Singulair, there were no reports of suicidal thoughts or actions and no completed suicides in the patients who received Singulair,” the company’s statement said.
The FDA has asked Merck to review all its clinical data for evidence of suicidality or suicide. And the agency said it will review the postmarketing reports it has received on behavior and mood changes, suicidality, and suicide. The FDA said its investigation will take 9 months.
The American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology said in a statement: “There are no data from well-designed studies to indicate a link between Singulair and suicide. The concern expressed by the FDA is based entirely on case reports…. It is unknown whether there is an increased incidence of suicide in patients receiving Singulair.”
The two organizations recommended that patients taking Singulair tell their physician if any suicidal behavior or thoughts occur.
The FDA and Dr. Philip said that until the data review is completed, patients should not stop taking Singulair. The agency did urge physicians to monitor patients for signs of suicidality and other psychiatric events.
The FDA is also reviewing postmarketing reports it has received of behavior/mood changes, suicidality, and suicide in patients who took other leukotriene-modifying therapies, including zafirlukast (Accolate) and zileuton (Zyflo and Zyflo CR). It will then assess whether further investigation is warranted.
BY ALICIA AULT Associate Editor, Practice Trends
COPYRIGHT 2008 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning