The U.S. Food and Drug Administration (FDA) announced in an Early Communication warning that it is investigating a possible association between Merck & Co, Inc.’s asthma and allergy drug, Singular, to suicide, behavior/mood changes and suicidality (suicidal thinking or behavior).

Current FDA actions

According to the FDA’s Early Communication warning, http://www.fda.gov/cder/drug/early_comm/montelukast.htm, it has:

• Requested Merck & Co., Inc. to perform additional studies
• Stated that its ongoing investigation will take nine months to complete
• Urged healthcare professionals and patients to report any side effects from Singulair, as well as similar drugs such as Accolate, Zyflo and Zyflo CR, to the FDA’s MedWatch Event Reporting program at www.fda.gov/medwatch/report.htm.

Singulair

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. It has been on the market for approximately 10 years.

Clinical trials

According to a press release on Merck’s website (www.singulair.com), two clinical trials have been conducted on the use of Singulair – one which included 11,000 adults and children in over 40 study groups and another which included over 3,900 adults and children. Although only one patient attempted suicide, Merck says that the studies were not specifically designed to compare the rate of suicide in patients taking the drug.

FDA looking at similar drugs

The FDA has stated that it is reviewing post-marketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took zafirlukast (Accolate) and zileuton (Zyflo and Zyflo CR.)

If you or a loved one has been injured due to the use of one of these drugs, consider contacting an attorney to discuss your situation. Consultations are strictly confidential and without charge or obligation. To contact a qualified attorney who may be able to help, please click here.