Singulair® (montelukast) is a popular prescription drug that is widely used for the treatment of asthma symptoms and the relief of seasonal hay fever allergies. It was recently discovered, however, that prolonged use of Singulair may cause some users to develop mental health problems. Our firm is now seeking new cases from people who were diagnosed with mental health disorders after using Singulair.About Singulair
The active ingredient in Singulair, montelukast, was developed and patented by Merck & Co. Inc. and first approved for clinical use in the U.S. in 1998. Since then, Singulair has become a very widely used prescription medication for the treatment of asthma and seasonal allergy symptoms. The original patent protection on Singulair is expired so it is available in both brand and generic form.
Singulair is not a steroid, like most asthma medications. Instead, it works by blocking certain chemicals in the body called leukotrienes which are released in response to allergens and other triggers and cause airways to tighten and fluid to invade the respiratory system.
Over 9 million people in the U.S. had Singulair prescriptions dispensed in 2019, either as an add-on or alternative to inhaled corticosteroid medications. A large percentage of Singulair patients are children. 2.3 million patients who received Singulair prescriptions were under 17, which is roughly 30% of all users.FDA Requires New “Black Box” Warning for Neuropsychiatric Side Effects Linked to Singulair
One of the unique aspects of Singulair is that it has the ability to cross over the blood-brain barrier (“BBB”). It is one of the few types of medications that are known to cross the BBB, which is a protective barrier that protects the brain from pathogens. Singulair’s ability to cross the BBB means that the drug gradually accumulates in the central nervous system and eventually the brain tissue.
When Singulair accumulates in the nervous system and brain, it can cause neuropsychiatric events and mental health disorders. Studies have shown that prolonged Singulair users are twice as likely to develop mental health disorders. Children who use Singulair have an even higher risk level for this side effect.
The link between Singulair and neurologic problems was first identified back in 2007. This discovery prompted Merck to update the warning label on Singulair in 2008 to include information about the risk of neuropsychiatric events with prolonged use. In March 202, however, the Food and Drug Administration required Merck to use a so-called “black box warning” (the highest level of drug warning) on Singulair moving forward.
The new black-box label for Singulair contains a heightened warning about the considerable risk of serious mental health issues attributed to the extended use of Singulair's active ingredient - montelukast. The label identifies aggression, depression, and suicidal thoughts and behaviors as some of the potential mental health disorders associated with the drug. In addition to the black box warning, the FDA also requires a new medication guide to be given to all patients who receive a new montelukast prescription.
These new requirements by the FDA were prompted by a collection of medical studies that found that the risk of mental health disorders from Singulair from significantly higher than compared to traditional steroid medications for asthma. The net result of the new warning label and medication guidance is that doctors are basically advised not to prescribe Singulair unless alternative medications are not an option. In effect, Singulair’s risk of mental health issues has made the drug a treatment option of last resort.Singulair (Montelukast) Lawsuits
Lawsuits are now being filed against Merck by individuals who used Singulair (or a generic version of montelukast) and were subsequently diagnosed with a mental health disorder or experienced a neuropsychiatric episode resulting in physical harm. These lawsuits allege that Merck was fully aware of the risk of neuropsychiatric problems associated with Singulair, but deliberately concealed them and failed to warn doctors and patients. Plaintiffs in Singulair lawsuits are seeking damages for medical expenses, lost wages, and pain and suffering connected to mental health disorders by users of Singulair.Contact Us About Your Singulair (Montelukast) Mental Health Lawsuit
If you or a family member used Singulair (or a generic montelukast medication) and were subsequently diagnosed with serious mental health problems resulting in physical harm or hospitalization, contact our office today for a free case evaluation.FAQs – Singulair Lawsuits
Neuropsychiatric side effects are mental health problems and disorders such as clinical depression, anxiety, aggression, and suicidal thoughts and behaviors.
Singulair has not been recalled, but it is generally not considered safe for use by young patients (18 and under) because it has been linked to a high risk of mental health disorders and neurologic abnormalities.
Singulair (montelukast) has been linked to neurologic events and mental health disorders and can potentially cause psychosis.
Yes. Singulair has been scientifically linked to neurologic problems and mental health disorders, including anxiety.
Yes. As of March 2020, the FDA required Singulair (montelukast) to contain a so-called black box warning label on the risk of mental health disorders and problems associated with the drug.