Merck’ Declaration In Response To FDA's Update On Singulair

Published: 12-Jun-2009

Singulair, supported by data from controlled clinical trials in more than 20,000 patients

New Jersey-based Merck has issued the following statement in response to the FDA’s updated information on leukotriene inhibitors, including Singulair (montelukast sodium).

Since the introduction of Singulair, the company has updated the post-marketing section of the prescribing information to communicate a range of adverse events reported with post-marketing use of the drug. This included the types of neuropsychiatric events addressed in the FDA's communication, said the company.

The efficacy and safety profile of Singulair is supported by data from controlled clinical trials, in which more than 20,000 patients received Singulair, and from a review of post-marketing adverse event reports collected since the drug was approved by the FDA.

The company said that it will continue communicating with patients, parents and health care providers about Singulair in ways that will help inform their decisions about appropriate treatment choices. Patients and parents of children with asthma or allergies should talk with their health care providers if they have any questions about the benefits and risks of Singulair.

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