Voltaren Gel Gets FDA Nod for OTC, Nonprescription Use

“We are pleased to see a long-time — and often go-to — prescription medicine like Voltaren gel and cream become available over-the-counter …”


The U.S. Food and Drug Administration (FDA) has announced the approval of Voltaren Arthritis Pain gel and cream for nonprescription, over-the-counter (OTC) use.

Voltaren Arthritis Pain contains diclofenac sodium topical gel 1%, which is a non-steroidal anti-inflammatory drug (NSAID).

Developed by GlaxoSmithKline, the gel was previously available only under a prescription, which is advised for temporary relief of joint pain caused by osteoarthritis (OA).

Responding to the FDA announcement, Director of the RJ Fasenmyer Center for Clinical Immunology at the Cleveland Clinic, Leonard Calabrese, said, “The approval of OTC diclofenac is overdue. 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.”

Co-founder of nonprofit patient community CreakyJoints, Seth Ginsberg, welcomed the FDA announcement, stating that it will help increase access to care and treatment options for those who have 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,” he continued. “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.”

Ginsberg explained that the availability of Voltaren without a prescription means that patients do not require visiting a doctor and getting a prescription, saving them time as well as 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 Voltaren’s new OTC status could increase out-of-pocket costs for patients who used to get it through a pharmacy benefit via their health insurance.

The FDA approved Voltaren Gel 1% in 2007 for the topical treatment of joint pain caused by OA. However, it has not been approved for bruises, strains, sprains, or sports injuries.

Osteoarthritis is the most common form of arthritis, affecting millions of people worldwide, according to Mayo Clinic.

The US drug regulatory body changed the drug’s status from prescription to nonprescription after reviewed the data of its safety and efficacy for self-medication used under proposed labeling.

FDA’s Karen Mahoney said, “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.”

“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,” she added. “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.”