(CNN)The United States Food and Drug Administration revealed Wednesday it is needing a boxed caution– the firm’s most popular caution– for the asthma and allergic reaction medication montelukast, offered under the brand Singulair.
“The occurrence of neuropsychiatric occasions connected with montelukast is unidentified, however some reports are severe, and numerous clients and healthcare specialists are not totally familiar with these dangers,” stated Dr. Sally Seymour, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
“Importantly, there are numerous other safe and reliable medications to deal with allergic reactions with comprehensive history of usage and security,” she stated.
The FDA reached this choice after re-evaluation of the threats and advantages of montelukast compared to other readily available treatments that have actually gone into the marketplace because the drug was very first authorized in 1998. It figured out the threats of montelukast might exceed its advantages, particularly for individuals with moderate allergic reactions. If clients have actually stopped working or can not endure other treatments, it advises utilizing montelukast just.
In addition to the boxed caution, the FDA is likewise needing a brand-new Medication Guide to be offered to clients with montelukast prescriptions.