Merck Statement on the FDA Early Communication of an Ongoing Safety Review of Montelukast (SINGULAIRâ„¢)
WHITEHOUSE STATION, N.J., March 27, 2008 - Merck & Co., Inc. issued the following statement in response to the FDA Early Communication of an Ongoing Safety Review of Montelukast (SINGULAIRâ„¢) that was posted today on the FDA website.
SINGULAIR has been marketed in the US for 10 years and millions of patients have been prescribed SINGULAIR in the US and around the world.Â Merck voluntarily updated the worldwide product label for SINGULAIR in October 2007 to include "suicidal thinking and behavior" and included similar changes to the patient product information.Â These actions were based on a very limited number of post-marketing adverse event reports that Merck has received.Â Since that time, Merck has worked with the U.S. Food and Drug Administration to provide further clarity in the product label as well as to further communicate this information to physicians.
Information from post-marketing reports is incorporated by Merck into the product label and patient product information as appropriate to help inform healthcare practitioners and patients.Â The fact that an adverse event has been reported to Merck and to regulatory agencies does not reflect a conclusion that the post-marketing event is caused by SINGULAIR.Â In general, a post-marketing adverse event may be caused by underlying disease, genetic condition, the medication, concomitant medications or background event that may occur in any population.
In a cumulative analysis recently provided to the FDA of Merck's randomized, double-blind, placebo-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.
Additionally, in a cumulative analysis recently provided to the FDA of Merck's randomized, double-blind, clinical trials that compared SINGULAIR with other active agents to treat asthma (which included over 3,900 adults and children who were treated with SINGULAIR and over 3,400 who were treated with other asthma therapies), there was 1 patient who attempted suicide who received SINGULAIR, and there were 3 patients who attempted suicide who received other asthma therapies (including inhaled corticosteroids and long-acting beta-agonists).Â These studies were not designed to compare the rate of suicide in patients taking SINGULAIR with the rate of suicide in patients taking these other asthma agents.
In clinical studies in patients with asthma, adverse events were generally mild and varied by age.Â The most common adverse events in clinical trials in adults and adolescents with asthma ages 15 and older were headache, influenza, abdominal pain, cough and dyspepsia.Â Â In clinical studies in patients with allergic rhinitis, SINGULAIR was generally well tolerated with a safety profile similar to placebo.Â The most common adverse events in these clinical trials included sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, headache, otitis media, pharyngitis and increased ALT.
In the United States, Merck has been and continues to communicate the updated prescribing information for SINGULAIR to physicians through several channels - including calls to physicians from our sales representatives who have been distributing and proactively informing physicians about the updated prescribing information and patient product information.Â Merck has updated the prescribing information and patient product information on the Website and the patient product information that accompanies the print ads to include these post-marketing reports.
Patients on SINGULAIR, or parents with a child on SINGULAIR should talk with their doctor if they have questions.Â Doctors are in the best position to explain the benefits and risks of taking SINGULAIR.Â Patients can also go to Singulair.com to obtain the Patient Product Information and prescribing information.
Merck has been working with regulatory agencies worldwide to update the prescribing information in those countries.Â Merck is committed to providing accurate information about the efficacy, safety and tolerability of our medicines.
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 two years and older, and for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and children six months and older.
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.Â 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.
The prescribing information and patient product information for SINGULAIR are available at the links above.
This statement contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995.Â These forward-looking statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements.Â The forward-looking statements may include statements regarding product development, product potential or financial performance.Â No forward-looking statement can be guaranteed and actual results may differ materially from those projected.Â Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.Â Forward-looking statements in this statement should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.Â