Merck & Co., Inc. issued the following statement in response to communication from the U.S. Food & Drug Administration (FDA) addressing updated information on leukotriene inhibitors, including SINGULAIR (montelukast sodium).
Since the introduction of SINGULAIR in 1998, 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, including the types of neuropsychiatric events addressed in the FDA’s communication. Merck will continue to work with the FDA to revise the prescribing information for SINGULAIR in the United States to include a precaution related to those events.
Merck is confident in the efficacy and safety of SINGULAIR, a medicine that has been prescribed to tens of millions of patients with asthma and allergic rhinitis since its approval more than 11 years ago.
“For the millions of people suffering from either asthma or allergic rhinitis, SINGULAIR is an important treatment option for appropriate patients,” said Scott Korn, M.D., vice president, Clinical Risk Management and Safety Surveillance, Merck Research Laboratories.
SINGULAIR is indicated for the prevention and chronic treatment of asthma in adults and pediatric patients 12 months of age and older, for the relief of symptoms of seasonal allergic rhinitis (SAR) in adults and children 2 years and older, and for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and children 6 months and older. The efficacy and safety profile of SINGULAIR is supported by available 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.
Merck 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. Patients should talk to their health care providers before starting or stopping treatment with any prescription medicine.
Date: June 15, 2009
Source: Merck and Co., Inc.