December 2, 2022

FDA approves topical arthritis pain reliever for non-prescription 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 sensitive to topical treatment, particularly the joints of the hands, knees and feet.

The FDA has announced Diclofenac Sodium 1% Topical Gel (Voltaren Arthritis Pain, GlaxoSmithKline) as an over-the-counter (OTC) option for the temporary relief of arthritis pain.1

Approval for non-prescription use is based on clinical data demonstrating that the drug is safe and effective for self-medication, and that consumers can understand how to use the drug safely without the supervision of a healthcare practitioner. .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 sensitive to topical treatment, particularly the joints of the hands, knees and feet. . It hasn’t 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 injury or obesity. According to the Arthritis Foundation, this can lead to 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 consult a healthcare practitioner if their pain does not improve in 7 days or if they must use the product for more than 21 days.1

OTC prescription shift approval is an important step in improving patient access to treatment, said Karen Mahoney, MD, acting deputy director of the FDA’s Office of Nonprescription Drugs , in a press release.1

“The approval of a wider range of over-the-counter 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 with a prescription,” said Mahoney . “This includes providing the millions of people with joint pain from arthritis with daily over-the-counter access to another non-opioid treatment option. “1

THE REFERENCES

  • FDA Approves Three Drugs For Non-prescription Use Via Rx-to-OTC Switching 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.