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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:

Eye drop Medication

“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.

Pharmacist explaining medication

“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.

Have Questions about Voltaren or Pataday? Ask a Forward Pharmacist

All three products will be marketed in the U.S. as nonprescription drugs and will no longer be available as prescription drugs. If you use the newly available medicines, be sure to read and follow the drug facts labels for the nonprescription products. And as always, talk to your Forward pharmacist or your doctor if you currently take a prescription version of these products and have questions about the Rx-to-OTC switch. We’re here to answer your questions!

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.

Information on Voltaren Arthritis Pain

Voltaren Arthritis Pain is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing substances in the body that cause pain and inflammation. Voltaren Arthritis Pain is intended for the temporary relief of joint pain due to the most common type of arthritis, osteoarthritis, which increases with age, affects millions of people in the U.S., and can generally be self-diagnosed. Arthritis is the swelling and tenderness of one or more of your joints. Symptoms of arthritis include pain, swelling, stiffness, and difficulty moving a joint.

As a prescription drug, Voltaren Arthritis Pain was previously referred to as Voltaren Gel 1%, and was prescribed for the relief of the pain of osteoarthritis of joints responsive to topical treatment, especially joints in hands, knees and feet. Now, patients can take this medicine for these symptoms without a prescription. It hasn’t proven as effective for strains, sprains, bruises or sports injuries.

Voltaren Arthritis Pain can take up to 7 days to work once you have started taking the medicine daily—in other words, it doesn’t work for immediate relief. Here are some precautions to take note of if you start taking Voltaren:

  • If your arthritis pain is not improved in 7 days oryou need to use the product for more than 21 days, you should stop use and talk to your doctor.
  • The active ingredient in Voltaren Arthritis Pain, diclofenac, may cause a severe allergic reaction, especially in people allergic to aspirin. If an allergic reaction occurs, you should stop use and seek medical care immediately.
  • Liver damage can occur if this product is used more or longer than directed or when using other products containing diclofenac. This product contains an NSAID, which may cause severe stomach bleeding. NSAIDS, except aspirin, increase the risk of heart attack, heart failure and stroke, which can sometimes be fatal. The risk is higher if consumers use more than directed or for longer than directed.
  • If you pregnant or breastfeeding, you should check with a health care professional before using. This product should not be used during the last 3 months of pregnancy unless you have been definitely directed to do so by a doctor, because diclofenac may cause problems in the unborn child or complications during the delivery.

Published on Mar 05 2020