Merck Statement In Response To The FDA's June 12, 2009 Communication With Updated Information On Leukotriene Inhibitors, Including SINGULAIR(R)

Main Category: Respiratory / Asthma
Also Included In: Allergy
Article Date: 15 Jun 2009 - 2:00 PDT

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Merck & Co., Inc. issued the following statement in response to today's 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.

Important safety information about SINGULAIR

The use of SINGULAIR for chronic treatment of asthma may not eliminate the need for inhaled or oral corticosteroids. While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, SINGULAIR should not be abruptly substituted for inhaled or oral corticosteroids. Patients should be advised to take SINGULAIR daily as prescribed for chronic treatment of asthma even when they have no symptoms, as well as during periods of worsening asthma, and to contact their physician if their asthma is not well controlled.

In clinical studies in patients with asthma, adverse events were generally mild and varied by age. The most common adverse events in clinical trials in adults and adolescents with asthma ages 15 years and older were headache, influenza, abdominal pain, cough and dyspepsia. In clinical studies in patients with allergic rhinitis, SINGULAIR was generally well tolerated with a safety profile similar to placebo. The most common adverse events in these clinical trials included sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, headache, otitis media, pharyngitis and increased alanine aminotransferase (ALT). Less common side effects that have happened with SINGULAIR include behavior and mood related changes [agitation including aggressive behavior, bad/vivid dreams, depression, feeling anxious, hallucinations (seeing things that are not there), irritability, restlessness, suicidal thoughts and actions (including suicide), tremor, trouble sleeping].

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Merck