FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process | FDA

FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process | FDA



FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process

The U.S. Food and Drug Administration today approved three drugs for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary relief of arthritis pain;  Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander; and Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%) for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander, for nonprescription use. Voltaren Arthritis Pain is not for immediate relief and may take up to 7 days to work. Consumers should stop use and seek medical attention if their arthritis pain is not improved in 7 days or they need to use the product for more than 21 days. The active ingredient in Voltaren Arthritis Pain, diclofenac, may cause a severe allergic reaction, especially in people allergic to aspirin. If an allergic reaction occurs, consumers are advised to stop use and seek medical care immediately. Liver damage may occur if this product is used more or longer than directed or when using other products containing diclofenac. This product contains an NSAID, which may cause severe stomach bleeding. NSAIDS, except aspirin, increase the risk of heart attack, heart failure and stroke. These can be fatal. The risk is higher if consumers use more than directed or for longer than directed. If pregnant or breastfeeding, consumers should talk to a health care professional about use. This product should not be used during the last 3 months of pregnancy unless the consumer is definitely directed to do so by a doctor because diclofenac may cause problems in the unborn child or complications during the delivery. Pataday Twice Daily Relief was first approved by the FDA in 1996 under the name Patanol as a prescription drug and was indicated for the treatment of the signs and symptoms of allergic conjunctivitis (referring to ocular redness and itching due to allergies). Pataday – now Pataday Once Daily Relief – was first approved by the FDA in 2004 as a prescription drug and was indicated for the treatment of ocular itching associated with allergic conjunctivitis. Consumers are advised to stop use and talk to their health care professional if they experience eye pain, changes in vision, increased redness of the eye, worsening of itching or itching lasting for more than 72 hours.

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