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Is oral ketotifen aproved by the FDA?

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masso 25 Mar 2016

"One author served on the Food and Drug Administration (FDA) Pulmonary–Allergy Drugs Advisory Committee and chaired that group from 1984 to 1986. Approval for treatment of asthma was not granted, but FDA staff did recommend more extensive evaluations for management of urticaria. Unfortunately, the latter studies have not been performed in a robust fashion. However, oral ketotifen has been used in patients with asthma, allergic rhinitis, allergic conjunctivitis, atopic dermatitis, chronic urticaria, cold-induced urticaria, cholinergic urticaria, exercise-induced urticaria, mastocytosis, and food allergy in Canada, Europe, and Mexico. Approval was granted for ocular administration in the United States for allergic conjunctivitis and later the drug became available over the counter. A review of clintrials.gov shows evaluations of ketotifen by oral administration for fibromyalgia, atopic dermatitis, attenuation of reactions during peanut desensitization, allergic rhinitis, asthma, and post-traumatic joint contractures. The authors became aware that ketotifen could be obtained in the United States from compounding pharmacies and began prescribing it more extensively in their clinics for severe urticaria in 2011. For adults and older children with asthma or allergic disease, the recommended dose of ketotifen is 1 mg twice daily. For young children 6 months to 3 years old, the recommended dose is 0.5 mg twice daily.3

It must be noted that oral ketotifen can be safely compounded in the United States. Pharmacy compounding is a practice in which a licensed pharmacist combines, mixes, or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient. Pharmacy compounding, if performed properly, can serve an important public health need if a patient cannot be treated with an FDA-approved medication. The issue of safety of compounded drugs in the FDA Compliance Policy for Pharmacy Compounding is primarily for injectable drugs and does not relate to oral compounded drugs. This policy does include a select list of compounding drugs that were withdrawn or removed from the market for safety reasons, which does not include ketotifen."

source: National Center for Biotechnology Information, U.S. National Library of Medicine

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