Getty Images A new FDA boxed warning cautions against prescribing the asthma and allergy drug Singulair for people with mild symptoms, including those with hay fever
Experts say that the Singulair incident highlights a flawed system, both in the U
Food and Drug Administration (FDA) strengthened existing warnings regarding the mental and behavioral health side effects
The U
[Posted 03/04/2020] AUDIENCE: Patient, Health Professional, Pharmacy, Allergy and Immunology ISSUE: FDA is strengthening existing warnings about serious behavior and
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FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis 3/4/2020 The FDA has stayed abreast of this research: from 2008, it has communicated its drug safety reviews of montelukast (Singulair) to the public, 6 and in 2014, the FDA’s Nonprescription Drugs Advisory Committee rejected an application for brand name Singulair medication to be approved for over -the-counter (OTC) use based on clinical
To address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants, the U
cold symptoms such as runny or stuffy nose, sinus pain, cough, sore throat
The FDA says the drug will now feature their “most prominent warning” and comes after “continued reports of neuropsychiatric events with
For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet
SINGULAIR may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see Warnings and Precautions (5
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The mechanisms underlying NP events Tell your healthcare provider right away if you get one or more of these symptoms: a feeling of pins and needles or numbness of arms or legs
The FDA’s most serious warning, a “Black Box Warning” will now be found on the packaging for popular asthma and allergy medication from now on
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( NewsNation) — An asthma and allergy drug that has been known to cause aggression and suicidal thoughts was reportedly prescribed to millions of people in 2022, despite warnings from federal regulators about the dangerous side effects
The agency also says