FDA News Release
FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process
- For Immediate Release:
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.
“As a result of the Rx-to-OTC switch process, many products sold over-the-counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” said Karen Mahoney, M.D., acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research. “Approval of a wider range of nonprescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription. This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another non-opioid treatment option.”
The process of changing the status of a drug from prescription to nonprescription is called an Rx-to-OTC switch. It is usually initiated by the manufacturer of the prescription drug. For a drug to switch to nonprescription status, the data provided must demonstrate that the drug is safe and effective for use in self-medication as directed in proposed labeling. The manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.
Voltaren Arthritis Pain is a nonsteroidal anti-inflammatory drug (NSAID) and works by reducing substances in the body that cause pain and inflammation. This product, previously referred to as Voltaren Gel 1%, was first approved by the FDA in 2007 as a prescription drug and was indicated for the relief of the pain of osteoarthritis of joints responsive to topical treatment, in particular, the joints of the hands, knees and feet. It has not been shown to work for strains, sprains, bruises or sports injuries.
Voltaren Arthritis Pain is intended for the temporary relief of joint pain due to the most common type of arthritis, osteoarthritis, which increases with age, affects millions of people in the U.S., and can generally be self-diagnosed. Arthritis is the swelling and tenderness of one or more of your joints. Symptoms of arthritis include pain, swelling, stiffness, and difficulty moving a joint.
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. These drugs are mast cell stabilizers, which work by preventing the release of histamine and therefore prevent or control allergic disorders. Ocular itching caused by allergens is a common ailment in the U.S., affecting millions of people. 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.
All three products will be marketed in the U.S. as nonprescription drugs and will no longer be available as prescription drugs. Consumers should read and follow the Drug Facts labels for the nonprescription products. Patients who currently take prescription versions of these products and have questions about the Rx-to-OTC switch should talk to their health care professional.
The FDA granted the approval of nonprescription Voltaren Arthritis Pain to GlaxoSmithKline plc. The FDA granted the approvals of nonprescription Pataday Twice Daily Relief and Pataday Once Daily Relief to Alcon.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs; vaccines and other biological products for human use; and medical devices. The Agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation; and for regulating tobacco products.
- Amanda Turney