The U.S. Food and Drug Administration (FDA) has given the go-ahead for the over-the-counter (OTC) sale of Voltaren Arthritis Pain, a topical gel for the temporary relief of osteoarthritis pain. Since 2007, the medication has been available only by prescription.?
“This medication now gives consumers another OTC option to use for osteoarthritis in addition to ibuprofen [Advil], naproxen [Aleve], acetaminophen [Tylenol], and capsaicin cream,” says Francis Luk, MD, a rheumatologist at Wake Forest Baptist Health in Winston-Salem, North Carolina.
Osteoarthritis is inflammation, swelling, and tenderness in the joints that can lead to pain, stiffness, and difficulty moving. In the United States, about 30 million adults live with the condition, according to the Centers for Disease Control and Prevention.
Yili Huang, DO,?the director of the pain management center at Northwell Health’s Phelps Hospital in Sleepy Hollow, New York, has been prescribing Voltaren gel for his osteoarthritis patients and welcomes its OTC sale.
“The gel is generally effective in treating localized pain that is directly under the skin or in?superficial?joints [such as the ankle, knee, hands, wrist, and elbow],” says Dr. Huang.
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Making Pain Relief More Readily Available
The approval comes as part of a process called an Rx-to-OTC switch, in which the manufacturer (in this case, the pharmaceutical company GlaxoSmithKline) must demonstrate that a drug is safe and effective for use in self-medication.
The OTC form of Voltaren gel should be just as effective as the prescription version because it is the same strength and formula as the original product, according to GlaxoSmithKline (GSK), the only company given the FDA’s blessing to sell the diclofenac gel as an OTC product.
“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,” said?Karen Mahoney, MD,, the acting deputy director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, in a press release.
The product is expected to be available for purchase in stores in spring 2020, according to GSK. Pricing information is not yet available, but the pharmaceutical firm says it will be comparable to other OTC arthritis-pain medications on the market.
The Consumer Healthcare Products Association points out that in general, OTC medicines are more affordable that prescription drugs, saving the U.S. healthcare system $51.6 billion in drug costs every year. That translates to significant savings for the American consumer.
A Safe, Low-Dose Option for Pain Relief
As a 1 percent gel that can be applied directly to the skin, this nonsteroidal anti-inflammatory drug (NSAID) has a favorable safety profile when used as directed because it contains such a low amount of the active ingredient, diclofenac sodium. Like other NSAIDs, Voltaren works by temporarily blocking the production of pain-signaling chemicals called prostaglandins.
“The gel can be a safer option for patients who cannot tolerate the side effects of oral nonsteroidal anti-inflammatories,” says Huang. “It seems to have a better safety profile than other already over-the-counter nonsteroidal anti-inflammatory pills such as naproxen or ibuprofen.”
Neha Shah, MD,?a rheumatologist with Stanford Health Care in Palo Alto, California, adds that the gel may help individuals who are advised not to take oral NSAIDs.
“Patients with contraindications to using oral NSAIDs — such as chronic or acute kidney disease, use of a blood thinner, or peptic ulcer disease — can use the topical medication with minimal risk,” she says.
“However, it is not a substitute for disease-modifying antirheumatic drugs,” she says. “It will not actually treat rheumatoid arthritis long term.”
Gel Is an Alternative to Oral Diclofenac, a Pill
Shah stresses that as a gel, a smaller percentage of the product gets absorbed into the body compared with the oral form of diclofenac (which is available only by prescription).
“The levels of the medication that you get with topical use are a fraction of what you get with oral use,” she says.
In its oral form, diclofenac side effects can include stomach problems such as gas, bloating, pain, cramping, constipation, bleeding, and diarrhea; headache and ringing in the ears; and rash. The medication may trigger more serious adverse events, such as low blood pressure, blood disorders, liver damage, and congestive heart failure.
Still, for patients who have deeper or more widespread inflammatory pain that may not respond to the gel, and for those who have not responded to over-the-counter nonsteroidal anti-inflammatory treatments, oral diclofenac may help if used according to doctor’s directions.
Still, Some Gel Side Effects Are Possible
Even with such a high safety profile, Voltaren Arthritis Pain is not completely free of side effects. Using too much of it too often may lead to rash, itching, a burning feeling, and negative outcomes similar to those caused by the oral diclofenac.
The FDA warns that the active ingredient in the gel may trigger a severe allergic reaction, especially in people allergic to aspirin. Liver damage may occur if this product is used more or longer than directed or in concert with other products containing diclofenac.
“That is why it is always important to consult with your healthcare provider on all medications that you are taking, even topical medications such as Voltaren,” says Huang.
The Gel Doesn’t Relieve Pain Right Away
Voltaren Arthritis Pain is not for immediate relief — it may take up to a week to take effect. The FDA advises consumers to stop using the product and seek medical attention if their arthritis pain is not improved in seven days or they need to use the product for more than 21 days.
“In general, I do not recommend continuation of any nonsteroidal anti-inflammatory for longer than two weeks because of its effects on stomach, kidneys, and heart,” says Huang.