The Food and Drug Administration (FDA) is allowing three previously prescription-only drugs to be sold over the counter: diclofenac sodium topical gel, 1% (Voltaren Arthritis Pain); olopatadine HCl ophthalmic solution/drops, 0.1% (Pataday Twice Daily Relief); and olopatadine HCl ophthalmic solution/drops, 0.2% (Pataday Once Daily Relief). The drugs will no longer be available by prescription. The FDA allows prescription drugs to become over-the-counter drugs if the manufacturer has supplied data showing the drug is safe and effective for self-medication and that consumers can understand how to use the drug independent of a health care professional.
Diclofenac sodium topical gel, 1%, is a topical nonsteroidal antiinflammatory drug (NSAID) used for temporary pain relief from most common forms of arthritis and osteoarthritis. The drug does not provide immediate relief and may take up to seven days to work. It has not been effective in treating swelling or pain related to strains, sprains, bruises, or sports injuries. The active ingredient, diclofenac, can produce severe allergic reactions, especially in people who have an aspirin allergy. Nurses should instruct patients to report any allergic reactions immediately. Patients should also be told to avoid using the drug for more than 21 days, as this may lead to liver damage (any topical medication may be absorbed through the skin). Large doses or use of the product for longer than recommended may induce adverse effects related to NSAID use: stomach bleeding, increased risk of heart attack, heart failure, and stroke. Women of childbearing age should avoid the drug during the last three months of pregnancy owing to risks to the unborn child and possible complications during delivery.
Olopatadine HCl ophthalmic solution/drops, 0.1%, and olopatadine HCl ophthalmic solution/drops, 0.2%, are eye drops for allergic symptoms. The two versions of the eye drops, which are mast cell inhibitors, are for temporary relief of itchy and red eyes due to pollen, ragweed, grass, and animal hair or dander. Patients using these drops should be advised to stop and contact their health care provider if they experience eye pain, changes in vision, increased eye redness, worsening of itching, or itching lasting more than 72 hours.
To read the FDA News Release regarding these three drugs, go to http://www.fda.gov/news-events/press-announcements/fda-approves-three-drugs-nonp.