The Food and Drug Administration (FDA) has added a stronger box warning to Singulair and its generic montelukast, a popular asthma and allergy medication, after “continued reports of neuropsychiatric events.” Potential side effects include suicidal thoughts and behaviors, agitation, aggression, attention problems, night terrors, depression, confusion, anxiety, hallucinations, memory problems, obsessive-compulsive symptoms, trouble sleeping or restlessness, and uncontrolled muscle movement or shakiness.

Stories of Singulair’s Severe Side Effects

Toni Dye, a mom from Zephyrhills, Florida, says that her daughter Kayla began taking Singulair at the age of 7. Soon after, she started having anxiety, panic attacks, and anger issues as well as nightmares. “She’d wake up in the middle of the night and be running around the house and just screaming,” Dye said. The change was so drastic that Dye and her husband took Kayla off Singulair after only a few weeks. 

That was 10 years ago. Now, at age 17, Kayla still suffers from anxiety, depression, and panic attacks. “I say that we lost our child because she’s not the same child anymore,” Dye added. “It hurts really bad. I feel guilty for not really looking into the drug.”

Angela Mitchell had a similar experience with her son, who started taking Singulair at 18 months old for severe allergies. After about eight months, she learned of the potential side effects and took him off. “He had become so despondent, so disconnected,” she shared. Additionally, he started exhibiting aggressive behaviors, including wanting to self-harm and harm others. 

Jennifer Brown personally experienced the side effects after only six days of taking montelukast for her asthma. “By the fourth day, I was already picturing myself dying,” she said. 

Recent Response From the FDA

All three women said that no one warned them about the risks for severe mental health side effects. In fact, they belong to a Facebook support group of more than 11,000 people with similar stories, many of which are even more severe and involve suicide. 

Members of this group have long pushed the FDA to take action. In March, the organization announced the requirement of the new box warning. “We are taking this action after a review of available information led us to reevaluate the benefits and risks of montelukast use,” the FDA said in its Drug Safety Communication. “Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions. However, many health care professionals and patients/caregivers are not aware of the risk. We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts.” 

A black box warning is the strongest warning that FDA can give to a medication. It is meant to increase awareness, especially for prescribing physicians and pharmacists. This label is the first step towards better education about the harmful side effects of Singulair and montelukast. 

For more information about Singulair and its generic version montelukast, contact us today.