Mometasone, commonly known as 3S, is a steroid (glucocorticoid). It is used to treat skin disorders like hay fever and asthma. It is intended solely to prevent, not treat, asthma attacks. The medicine can be rubbed onto the skin, inhaled, or used in the nose. Mometasone discontinued?
Mometasone furoate was approved for medical use in 1987 after being patented in 1981. This medication is listed on the World Health Organisation’s list of essential medicines and is accessible in generic form. In 2021, it was the 266th most often prescribed drug in the US, accounting for almost 1 million prescriptions. In this article, we analyze whether Momentasone has been discontinued.
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What is mometasone?
Mometasone is a prescribed medication. It is available in many forms. They are:
- nasal spray,
- nasal implant,
- inhalation powder or aerosol, and
- topical cream,
- lotion or ointment.
Mometasone nasal spray is sold under the brand name Nasonex. It’s also available as a generic medication. Generic medications are frequently cheaper than brand-name versions. However, they may not be available in all dosages or forms as prescription drugs in certain cases.
Mometasone nasal spray can be used as part of a combined treatment. This means you may need to take it alongside other prescriptions.
How does Mometasone work?
Mometasone nasal spray treats or prevents seasonal and year-round allergy-related nasal symptoms. It is also used to get rid of nasal polyps. These are non-cancerous growths in the nasal or sinus lining.
Mometasone nasal spray belongs to the class of medicines known as intranasal corticosteroids. A drug class is a set of medications that function similarly. These medicines are commonly used to treat similar symptoms.
Intranasal corticosteroids reduce sinus inflammation and swelling by preventing specific cells from generating substances that cause inflammation. These substances are typically produced when the body reacts to allergies or other irritations.
Is Mometasone discontinued?
Organon LLC owns NDA 020762, which covers Nasonex (mometasone furoate) nasal spray, 0.05 mg/spray 50 (mcg). The medicine was first authorized on October 1, 1997. Nasonex nasal spray is offered for:
- Treating patients two years of age and up for allergic rhinitis symptoms in their noses
- Treating patients two years of age and up for nasal congestion related to seasonal allergic rhinitis
- Treating patients 12 years of age and up for prevention of seasonal allergic rhinitis and
- Treating patients 18 years of age and up for nasal polyps.
Merck Sharp and Dohme Corp. are divisions of Merck and Co., Inc. In writing on December 4, 2020, they informed the FDA that NASONEX (mometasone furoate) nasal spray, 0.05 mg/spray 50 (mcg), would be discontinued. The FDA added the medication product to the Orange Book’s “Discontinued Drug Product List.”
Aurobindo Pharma Ltd. filed a citizen petition under 21 CFR 10.30 on January 14, 2022. The petition is for the agency to evaluate whether Nasonex nasal spray was removed from sale for safety or efficacy.
The FDA found that NASONEX was not discontinued for its safety or effectiveness. They confirmed this after evaluating agency records and the citizen petition.
The petitioner has no proof that Nasonex nasal spray has been discontinued for safety or effectiveness reasons. “We examined our files for records relating to the recall of Nasonex nasal spray from sale. We also examined relevant literature and data for potential postmarketing adverse events. We discovered no evidence that this medication product was withdrawn from sale due to safety or effectiveness concerns,” the FDA confirmed.
Mometasone discontinued products
Glenmark Pharmaceuticals Inc. recalled many batches of mometasone furoate topical solution. This recall was due to defective containers. US Food and Drug Administration (FDA) enforcement reported the recall on July 13, 2022.
The recall affects some products made by Glenmark Pharmaceuticals Limited, Himachal Pradesh, India, and Glenmark Pharmaceuticals, Mahwah, NJ. The following discontinued drugs are sold throughout the United States:
- Mometasone furoate topical solution, 0.1% (lotion), 30 mL bottle (NDC 68462-385-37)
- Mometasone furoate topical solution, 0.1% (lotion), 60 mL bottle (NDC 68462-385-02)
Glenmark Pharmaceuticals voluntarily issued the recall on June 16, 2022. On July 1, 2022, the FDA classified the recall as Class III. The recall classification shows that using the associated product is unlikely to cause harm.
Mometasone furoate topical solution is a prescription corticosteroid. It treats the inflammatory and pruritic symptoms of corticosteroid-responsive dermatoses.
Conclusion
The complexity of topical steroid discontinuation and its specific relation to mometasone furoate need further investigation. Mometasone furoate is a highly potent corticosteroid routinely used to treat skin disorders. The adverse effects of discontinuing the use of this topical steroid treatment have yet to be explored.
There are serious worries, accounts, discussions, and images circulating online about corticosteroid creams (not simply Mometasone furoate) causing topical steroid withdrawal. The media has taken notice of the increasing number of testimonies and experiences from the topical steroid withdrawal group.
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