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On March 2, 2011, the FDA announced that certain unapproved prescription cough, cold, and allergy products will be removed from the market. There are three general categories of products: "products in extended release form, products that contain tannates salts (e.g., phenylephrine tannate) as active ingredients, and certain immediate release products. ( http://www.gpo.gov/fdsys/pkg/FR-2011-03-03/pdf/2011-4703.pdf 1) Today’s action does not affect OTC cough, cold, and allergy products." It is clearest to simply quote the FDA website page . The list is here . I think this will affect some of my patients. Why? There was always a medical need for the medication. Some times, medications on this list were selected because there was a desire to have a prescription medication, not over-the-counter, and few choices were available on their insurance company's formulary. Sometimes, the pharmacy switched patients over. Sometimes, this medication was the least inexpensive option available. Sometimes, the medication works very effectively, but now the FDA has questions about the quality of the manufacturing process. |
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