FDA Orders Warning About Mental Health on Singulair Packaging
WASHINGTON, D.C. — The U.S. Food and Drug Administration, or FDA, announced that asthma and allergy drug Singulair (montelukast) could cause patients to experience suicidal ideations and actions. The FDA announced that it would order manufacturers of the drug to include a Boxed Warning on its montelukast packaging, calling the attention of the risk to the prescribing physician and patient. Additionally, the FDA indicated that most patients and health care professionals were unaware of the possible side effects of taking montelukast daily. Accordingly, the FDA ordered the Boxed Warning to draw attention to the problem. Furthermore, the FDA limited the use of montelukast for patients who take the drug to combat hay fever to those who have tried other prescription alternatives without relief.
The FDA indicates that its Boxed Warning is the most prominent warning signal the agency uses. The FDA Boxed Warning calls attention to the information contained within the box. The box sits in contrast to the other information contained in the pamphlet that accompanies the prescription medication. Setting out the information in a Boxed Warning should indicate to the user that the information contained in that box is vitally important to their health and well-being.
The FDA determined that asthma and allergy medication montelukast 10 create a severe mental health condition in the user. The FDA already mandated drug manufacturers to include warnings about suicidal thoughts and actions that could develop after consuming Montelukast over a long period. The FDA determined that prescribers, patience, and caregivers did not appreciate the severity of the threat. Many people, including medical professionals, according to the FDA, missed the warnings about mental health side effects entirely. As a result, the FDA determined that creating a Boxed Warning about the potential mental health side effects from taking montelukast.
The FDA recommends that patients discuss other options with their medical providers to determine whether continued use of montelukast is sufficiently beneficial compared to the risk of adverse mental health events.
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