The U.S. Food and Drug Administration now allowed three drugs for nonprescription, or over-the-counter (OTC), use through a process described a prescription (Rx)-to-OTC switch.
The FDA recommended 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 remission of tender 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 consequence of the Rx-to-OTC switch method, many goods sold over-the-counter today treatment components or dosage strengths that were accessible only by medicine 30 years ago,” stated Karen Mahoney, M.D., performing deputy manager of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research.
The Process Began
“Support of a wider range of nonprescription medicines has the potential to improve public health by expanding the types of medicines customers can obtain and use that would differ only be available by medicine. This involves implementing the millions of people that suffer from joint pain from arthritis daily over-the-counter introduction to another non-opioid therapy option.”
The process of improving the status of medicine from prescription to nonprescription is called an Rx-to-OTC switch. The company of the prescription medication initiates typically it. For a drug to switch to nonprescription status, the data presented must prove that the medication is safe and efficient for use in self-medication as directed in proposed labeling. The company must show that consumers can understand how to use the drug securely and efficiently 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 infection. This outcome, before referred to as Voltaren Gel 1%, was first established by the FDA in 2007 as a prescription drug and was indicated for the relief of the pain of osteoarthritis of joints responding to topical therapy, in particular, the bones 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 improves with age, affects millions of people in the U.S., and can usually be self-diagnosed. Arthritis is the inflammation 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 urgent relief and may take up to 7 days to work. Consumers should stop use and seek healing 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 component in Voltaren Arthritis Pain, diclofenac, may cause a severe allergic reaction, especially in people allergic to aspirin.
If an allergic reaction occurs, customers are encouraged to stop use and seek medical care immediately. Liver damage may occur if this product is used more or longer than delivered or when using other products, including diclofenac. This product contains an NSAID, which may cause severe stomach bleeding. NSAIDs, except aspirin, raise the risk of heart attack, heart failure, and stroke. These can be harmful.
The risk is higher if customers use more than organized or for longer than advised. If pregnant or breastfeeding, customers should talk to a health care expert about use. This product should not be used during the last three months of pregnancy unless the customer is advised to do so by a doctor because diclofenac may cause problems in the unborn child or difficulties during the delivery.
Pataday Twice Daily Relief was first established by the FDA in 1996 under the name Patanol as a prescription medication. It was meant 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 medication and was indicated for the treatment of ocular itching compared with allergic conjunctivitis.
These medications are mast cell stabilizers, which work by blocking the release of histamine and therefore avoid or control allergic disorders. Ocular itching induced by allergens is a common ailment in the U.S., affecting millions of people. Customers are advised to stop use and talk to their health care professional if they encounter eye pain, changes in vision, increased redness of the eye, worsening of itching or itching lasting for more than 72 hours.
All three results will be exchanged in the U.S. as nonprescription medications and will no longer be available as prescription drugs. Customers should read and follow the Drug Facts labels for nonprescription products.
Patients who currently take medicine versions of these results and have issues about the Rx-to-OTC switch should talk to their health professionals.
The FDA awarded the approval of nonprescription Voltaren Arthritis Pain to GlaxoSmithKline plc. The FDA gave the permissions 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, guards public health by encouraging the security, effectiveness, and security of human and veterinary medicines, vaccines and other biological products for human use; and medical devices. The Agency also is liable for the safety and protection of our nation’s food supply, cosmetics, dietary complements, and products that give off electronic radiation; and for controlling tobacco goods.