The FDA has approved Voltaren Arthritis Pain for nonprescription, over-the-counter use, according to a press release.
Voltaren (diclofenac sodium topical gel 1%, GlaxoSmithKline), a NSAID previously available only with a prescription, is intended for the temporary relief of joint pain due to osteoarthritis.
“The approval of OTC diclofenac is overdue,” Leonard H. Calabrese, DO, director of the RJ Fasenmyer Center for Clinical Immunology at the Cleveland Clinic, told Healio Rheumatology in reaction to the announcement. “While modest as a therapeutic, it has good benefits to risks, and for people with OA, affords a small step forward in providing pain relief and self-efficacy.”
Seth Ginsberg, president and co-founder of the nonprofit patient community CreakyJoints, as well as the Global Healthy Living Foundation, similarly welcomed the announcement, stating that the switch will increase access to care and treatment options for patients with OA.
“We are pleased to see a long-time — and often go-to — prescription medicine like Voltaren gel and cream become available over-the-counter as it provides greater access for people who need it,” Ginsberg told Healio Rheumatology. “Many CreakyJoints members use this as part of their treatment protocol to help reduce pain caused by arthritis. However, we always remind our community to consult with a doctor or pharmacist to ensure the safe and effective use of any product, particularly in the context of any prescription and other over-the-counter medications or supplements that they may take.”
According to Ginsberg, Voltaren’s new status will mean that patients will no longer be required to visit to a doctor and gain a prescription to access the drug, saving them time and money.
“As part of the service that pharmacies provide, patients can receive medical information about over-the-counter products free of charge by speaking with their pharmacist,” he added.
However, Ginsberg cautioned that the drug’s new over-the-counter status could result in increased out-of-pocket costs for patients who have previously received it through a pharmacy benefit via their insurance.
“Because this treatment is now over-the-counter, patients who relied on this medicine and received it as part of a pharmacy benefit through their insurance will likely lose that benefit and will be forced to pay out-of-pocket for it,” he said.