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FDA Issues Boxed Warning for Allergy Drug Singulair - What You Need to Know

With the arrival of March, spring is just around the corner. However, there has been spring-like weather in many areas of the country lately, which means pollen is already starting to spring up. As a result, more people are turning to their allergy medication to keep their springtime allergies at bay.

While there are many types of allergy drugs on the market that can help individuals with allergies and asthma. Unfortunately, one of the most popular of these medications can result in a number of potential side effects that can adversely affect some people who take it.

Black Boxed Warning for Serious Side Effects

Recently, the Food and Drug Administration or FDA made an announcement that popular medication Singulair, which is also generically known as montelukast, will now carry a boxed warning. According to the FDA, boxed warnings are the most prominent and are included in packaging inserts that have a black box around it.

Specifically, when it comes to Singulair, the FDA recommends against the drug being prescribed to people who have mild allergy symptoms such as hay fever. FDA officials reported that it has received numerous and continual reports of neuropsychotic incidents involving montelukast. Officials warned that some of the side effects include agitation, depression, sleep problems and suicidal thoughts and actions.

Overall, it was noted that the potential side effects certainly outweigh the benefits the drug provides for some people. This is especially the case when there are other medications that can accomplish the same mission of improving allergy symptoms.

The FDA said people who have hay fever or who can’t benefit from alternative therapies should use Singulair. It originally included a warning with the medication in 2008. However, this was done only after there were reports that some people taking it had a higher risk of experiencing psychiatric issues such as anxiety, depression, difficulty sleeping, hallucinations and even suicidal thoughts or actions.

Support for Stronger Warnings

The Allergy and Asthma Network or AAN was pushing for the boxed warning as a positive step forward. The organization’s president and chief executive officer, Tonya Winders, stated that AAN was the only organization that advocated for the black boxed warning to be issued. She pointed out that the Network had received many reports of families that were affected by neuropsychiatric side effects caused by montelukast.

Although Ms. Winders stated that the numbers account for under 10 percent of the total number of patients who have taken the drug, it’s important for people to recognize the warning signs and speak with their doctors about an alternative treatment. She further said that other prescription drugs and even medications over the counter could help to treat hay fever.

Other Possible Treatments

There are various alternatives for treating hay fever, such as over-the-counter antihistamines, eye drops and nasal sprays. People can even be more aware of what is causing their allergic reactions so they can try to avoid those triggers. Some of these options can include keeping the windows closed and even more frequent hand-washing.

Of course, there are other allergy medications available for treating allergy symptoms. However, many of them also come with their potential side effects. For example, Benadryl causes drowsiness, dizziness and headaches. For some people, the medication can cause more serious side effects like vision problems and difficulty urinating.

Antihistamines like Allegra, Claritin and Zyrtec tend to have fewer side effects, but they may result in drowsiness and headaches as well. However, none of these drugs can cause the serious mental health side effects like montelukast.

How Singulair Works

Singulair or montelukast is a drug that works differently than other allergy medications like antihistamines. It keeps the airways open to prevent inflammation, which is why it is also prescribed to treat asthma.

Winders explained that it is the only medication of its type in this particular class of drugs and that it is unknown if there are any other medications used to treat allergies and asthma that have the potential for neuropsychiatric side effects.

In addition, she said people should always use caution when taking this drug. She stated that it’s of utmost importance that patients notice the warning signs and take the necessary steps to speak with their doctor so they can come up with an effective alternative treatment to keep their allergies or asthma under control.

Overall, the FDA is stressing the importance of patients, healthcare professionals and caregivers being aware of the potential mental health side effects of montelukast. The boxed warning can help to raise awareness. Only individuals who cannot find relief from their hay fever should be treated with the medication. As for those with asthma, the FDA is urging doctors to consider the benefits and potential side effects before prescribing the medication.

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The content on this page is for informational and educational purposes only and does not constitute professional medical advice. Patients should not use the information presented on this page for diagnosing a health-related issue or disease. Before taking any medication or supplements, patients should always consult a physician or qualified healthcare professional for medical advice or information about whether a drug is safe, appropriate or effective.