FDA Approves Topical Arthritis Pain Reliever for Nonprescription Use
Diclofenac sodium topical gel was first approved by the FDA in 2007 as a prescription drug, and was indicated for the relief of osteoarthritis pain in joints responsive to topical treatment, particularly the joints of the hands, knees, and feet.
The FDA has announced diclofenac sodium topical gel, 1% (Voltaren Arthritis Pain, GlaxoSmithKline) as an over-the-counter (OTC) option for temporary relief of arthritis pain.1
The approval for nonprescription use is based on clinical data demonstrating that the drug is safe and effective for self-medication use, and that consumers can understand how to safely use the drug without the supervision of a health care professional.1
Diclofenac sodium topical gel is a nonsteroidal anti-inflammatory drug (NSAID), which works by reducing substances in the body that cause pain and inflammation. It was first approved by the FDA in 2007 as a prescription drug, and was indicated for the relief of osteoarthritis pain in joints responsive to topical treatment, particularly the joints of the hands, knees, and feet. It has not been shown to work for strains, sprains, bruises, or sports injuries.1
Osteoarthritis is the most common form of arthritis and tends to occur in middle age due to an injury or obesity. According to the Arthritis Foundation, it can result in pain and reduced mobility, as well as side effects from medications.2
Diclofenac sodium topical gel may take up to 7 days to work, and is not intended for immediate relief. Consumers should speak with a medical professional if their pain does not improve in 7 days or if they need to use the product for more than 21 days.1
Approving the prescription-to-OTC switch is an important step in improving patient access to treatments, said Karen Mahoney, MD, acting deputy director of the FDA’s Office of Nonprescription Drugs, in a statement.1
“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,” Mahoney said. “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.”1
- FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process [news release]. White Oak, MD; February 14, 2020. FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-three-drugs-nonprescription-use-through-rx-otc-switch-process. Accessed February 17, 2020.
- Osteoarthritis; Arthritis Foundation. https://www.arthritis.org/diseases/osteoarthritis. Accessed February 17, 2020.