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A new FDA program is making it easier for prescription drugs such as Voltaren to be available as over-the-counter medications. Getty Images
  • The FDA has approved the sale of the prescription drug Voltaren as an over-the-counter medication.
  • The approval is part of a new FDA program to make more drugs available without prescriptions.
  • Experts caution consumers that just because a medication is available over the counter doesn’t necessarily mean it’s completely safe to use.

A topical medication approved to temporarily relieve arthritis pain is one of several drugs recently approved under a Food and Drug Administration (FDA) program that allows prescription medications to be available over the counter.

That means the drug is easier for people to purchase because they no longer need a healthcare professional’s approval.

But like other over-the-counter medications, medical professionals warn that consumers shouldn’t be lulled into thinking it’s safe for everyone to use for an endless amount of time.

The specific arthritis drug is Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%), which is approved by the FDA for temporary relief of arthritis pain.

It’s a topical nonsteroidal anti-inflammatory drug (NSAID), one of the most common drugs to treat various forms of arthritis. Other NSAIDs include ibuprofen, aspirin, naproxen, and other common over-the-counter (OTC) pain relievers.

They’re not opioids, so there’s a lower risk of dependence than other approved pain medications such as Oxycontin, Vicodin, or Percocet.

Voltaren was approved last week under the FDA’s growing Rx-to-OTC switch list.

Over the past decade, other drugs to be moved from prescription to over-the-counter status include variations of Advil, allergy medicines such as Allegra and Flonase, and medications to treat red eyes, heartburn, and overactive bladder.

Dr. Karen Mahoney, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said many over-the-counter products sold today because of the Rx-to-OTC switch process 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,” Mahoney said in a statement.

“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,” she continued.

Voltaren is designed to provide temporary relief of joint pain due to osteoarthritis, the most common type of arthritis.

Like other NSAIDs, the FDA says Voltaren works by reducing substances in the body that cause pain and inflammation.

The recently OTC-approved dose, 1 percent, first received the FDA’s blessing in 2007 for joint pain throughout the body.

The FDA warns that Voltaren is not for immediate relief of pain and may take up to 7 days to effectively work.

The warning goes on to state that consumers should stop using the drug and seek medical attention if their pain isn’t improved in 7 days or they need to use the product for more than 3 weeks.

In other words, just because a drug is available without a doctor’s prescription doesn’t mean it’s safe for everyone to use.

Dr. Medhat Mikhael, a pain management specialist and medical director of the non-operative program at the Spine Health Center at MemorialCare Orange Coast Medical Center in Fountain Valley, California, warns people against a “false, pervasive belief” that over-the-counter medications are safe.

“This is categorically false,” Mikhael told Healthline. “OTC medications can cause much higher risks of complication if they’re used excessively and without clear indication/directions.”

Voltaren’s active ingredient is diclofenac, which may cause a severe allergic reaction, especially in people allergic to aspirin.

Other warnings include:

  • possible liver damage
  • stomach bleeding
  • increased risk of heart attack, heart failure, and stroke

The FDA warns that pregnant women in their third trimester should not use Voltaren because its active ingredient may cause complications during delivery or could harm their unborn babies.

Mikhael said that because Voltaren is available in a gel, some people may over-apply it, which could increase the likelihood of major side effects.

“The prescribed medication necessitates a doctor’s visit and a different process to access the medication, but this provides clear, safety instructions/directions, and is covered by insurance versus the OTC that often carries with it a false sense of safety and no control or limitations over the amount applied, and as a result, suffer potential complications,” he said.

Dr. Orrin Troum, a rheumatologist at Providence Saint John’s Health Center in Santa Monica, California, said that while it’s a good idea that Voltaren is now available without prescription, the public needs to be aware of possible side effects, including that it shouldn’t be taken with other NSAIDs.

Troum said Voltaren should be the first medication along with other conservative approaches, including other OTC pain relievers, as well as applying heat and cold, physical and occupational therapy, and other non-medicinal therapies.

More potent pain relievers, he said, should remain under a doctor’s care.

“Currently, the most effective medications for the many types of arthritis require monitoring by healthcare providers, so as not to be improperly used by the public,” Torum told Healthline. “Therefore, until safer effective medicines are discovered, these other medicines should be by prescription only.”