The Food and Drug Administration has approved formerly prescription-only Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for nonprescription use via a process known as a prescription to over-the-counter (Rx-to-OTC) switch, according to a news release from the agency.
“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,” Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release.
This switch to nonprescription status is usually initiated by the manufacturer, who must provide data that demonstrates the drug in question is both safe and effective as self-medication in accordance with the proposed labeling and that consumers can use it safely and effectively without the supervision of a health care professional.
This particular therapy is a topical NSAID gel and was first approved by the FDA in 2007 with the indication for relief of osteoarthritis pain. It can take 7 days to have an effect, but if patients find it takes longer than that or they need to use it for more than 21 days, they should seek medical attention. The gel can cause severe allergic reactions, especially in people allergic to aspirin; patients who experience such reactions are advised to stop use and seek immediate medical care. Other concerns include potential for liver damage with extended use; the possibility of severe stomach bleeds; and risk of heart attack, heart failure, and stroke.
The gel will no longer be available in prescription form.
Full prescribing information can be found on the FDA website, as can the full news release regarding this approval.