Three common drugs are making the switch from prescription to over-the-counter
The medicines, used to treat arthritis and allergy symptoms, were approved for nonprescription use by the FDA last month
The U.S. Food and Drug Administration recently approved three drugs to make the switch from prescription to nonprescription availability.
The three drugs newly approved to be sold over-the-counter are:
- Voltaren Arthritis Pain for the temporary relief of arthritis pain
Clinical name: diclofenac sodium topical gel, 1% - Pataday Twice Daily Relief for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander
Clinical name: olopatadine HCl ophthalmic solution/drops, 0.1% - Pataday Once Daily Relief for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander, for nonprescription use Clinical name: olopatadine HCl ophthalmic solution/drops, 0.2%
“Rx-to-OTC”: How the Process Works
The process of changing the status of a drug from prescription to nonprescription is called an “Rx-to-OTC” switch process. Usually, the manufacturer of the prescription drug initiates the process, which has to undergo approval by the FDA. The FDA is an agency within the U.S. Department of Health and Human Services that protects the public’s health by testing and verifying the safety and effectiveness of the medicines we take.
For a drug to switch to nonprescription status, there has to be convincing evidence that the drug is safe and effective for use in self-medication as directed in proposed labeling. The manufacturer has to show that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.
“Many products sold over-the-counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” says Dr. Karen Mahoney. The “Rx-to-OTC” process “has the potential to improve public health by increasing the types of drugs consumers can access and…provide the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another non-opioid treatment option.”
Karen Mahoney, M.D., is acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research.
Information on Pataday for Allergy Relief—Once Daily and Twice Daily
Both Pataday Twice Daily Relief and Pataday Once Daily Relief are mast cell stabilizers, which work by preventing the release of histamine and therefore prevent or control allergic disorders. Pataday Twice Daily Relief was first approved by the FDA in 1996 under the name Patanol, as a prescription drug prescribed for the treatment of the signs and symptoms of “allergic conjunctivitis” (which is the eye redness and itching you can get due to allergies). Pataday Once Daily Relief was first approved by the FDA in 2004 as a prescription drug and was indicated for the treatment of ocular itching (eye itching) associated with allergic conjunctivitis. Ocular itching caused by allergens is a common ailment in the U.S., affecting millions of people. Now, patients can take these medicines for these symptoms without a prescription.
As always, check with your doctor or your Forward Pharmacist if you have questions. If you experience eye pain, changes in vision, increased redness of the eye, worsening of itching or itching lasting for more than 72 hours, you should stop use and talk to a health care professional.
