When the FDA allowed drug companies to sell NSAIDs over the counter we were concerned. That’s because drugs like ibuprofen (Advil, Motrin IB, etc) and naproxen (Aleve) came with some pretty serious side effects including stomach irritation and bleeding ulcers. Given that tens of millions of Americans use such drugs every day, the potential problem worried us.
That was long before we learned that oral NSAIDs like celecoxib (Celebrex), diclofenac (Cataflam, Voltaren) naproxen (Naprosyn) and meloxicam (Mobic) could also cause heart attacks and strokes. In addition, there are now data to suggest that when you swallow NSAIDs you increase your risk of developing hypertension, irregular heart rhythms (atrial fibrillation or A-fib), dizziness, blood clots, fluid retention, heart failure, ringing in the ears, liver or kidney damage.
Are Topical NSAIDs Safer?
Many other countries permit the sale of topical NSAIDs like Voltaren Gel over the counter. This reader would like to know if such products are safer than oral medicines:
Q. Please clarify whether Voltaren Gel used topically on my knee or spine carries the same risk as NSAID pills. I use a fingertip-size portion on a knee and a fingernail-size portion on one irritated vertebra as needed.
A rheumatologist prescribed it. Neither he nor my other doctor seems to know about NSAID risks with Voltaren Gel.
A. A review of 61 studies of topical NSAID pain relievers like Voltaren Gel concluded that these products provide “good levels of pain relief in acute conditions such as sprains, strains and overuse injuries, probably similar to that provided by oral NSAIDs” (Cochrane Database of Systematic Reviews, June 15, 2015).
This analysis found very few systemic adverse events like digestive tract irritation or cardiovascular complications. Nevertheless, some people are extremely susceptible to NSAID side effects. A few readers have reported stomach pain or abdominal cramps associated with Voltaren Gel use.
NSAID Side Effects:
For reasons that puzzle us, the FDA has seemed behind the rest of the world when it comes to topical NSAIDs. It took a long time for the agency to allow topical NSAIDs to be sold by prescription. Whether this was because the drug companies were slow to apply for approval or because the FDA was not enthusiastic about topical NSAIDs remains unclear. The FDA does not require oral NSAIDs sold OTC to carry a lot of scary warnings about side effect such as:
Oral NSAID Side Effects:
• Heartburn, indigestion, abdominal pain, nausea, vomiting, constipation, diarrhea
• Headache, dizziness, drowsiness, disorientation
Skin rash, sensitivity to sunlight, itching (potentially serious, so notify the MD!)
• Fluid retention, edema, high blood pressure
• Heart failure, heart attack, stroke
Ringing in ears, hearing changes
• Visual disturbances
• Ulcers, bleeding ulcers, perforated ulcers
• Liver damage, kidney damage
• Blood disorders, anemia
• Worsening asthma symptoms
• NEW: Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
Warnings on Topical Voltaren Gel:
There is a black box warning for Voltaren Gel that is similar to the warning with oral diclofenac:
“Non steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular events, including myocardial infarction [heart attack] and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
“NSAIDs can cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.”
FDA vs the Cochrane Collaboration:
We tend to trust the independent Cochrane analysis more than the FDA’s standard NSAID labeling. That’s because the Cochrane authors constantly review the latest research and include it in their assessment. The FDA often moves slowly to update its labeling. Here is the June 11, 2015 Cochrane conclusion about topical NSAIds for acute musculoskeletal pain in adults:
“Topical NSAIDs provided good levels of pain relief in acute conditions such as sprains, strains and overuse injuries, probably similar to that provided by oral NSAIDs. Gel formulations of diclofenac (as Emugel), ibuprofen, and ketoprofen, and some diclofenac patches, provided the best effects. Adverse events were usually minimal.”
Whitley in North Carolina:
“I started applying Voltaren Gel in 2007. I use it on my knees when I have an active period ahead. I get 5-6 hours of excellent pain relief from Voltaren Gel. Two doctors have told me that some NSAID will reach your blood but not in large enough amounts to worry about.
“I recently injured a rotator cuff and Voltaren Gel works very well on the shoulder. After 9 years I’ve had zero negative reactions.
“As to reading side effects on bottle – lawyers have made those lists so long my eyes glaze over. I read the main problems to look out for. Voltaren Gel works for me.”
E.B.M. also had good results:
“I have been buying Voltaren Gel in Germany and Mexico (Cozumel) and St. Maarten while traveling. It costs usually $10-15 overseas for a large tube and it has worked great for me and my friend who has rheumatoid arthritis and sometimes muscle spasms.
“I don’t use a lot since it is very easily spread (a thin gel) and my blood pressure is normal. I would not be without it.”
Ann in Ottawa offers a word of caution:
“I have had chronic pain for years and have been on a lot of different meds (both prescription and over the counter). They didn’t bother my stomach. I started using Voltaren Gel and now I am having a burning and gnawing pain in my stomach under my breast bone.”
Marilyn reacted to the topical gel, something that others also report:
“My doctor prescribed Voltaren Gel since pain meds upset my stomach. It didn’t upset my stomach, but on the fourth day of applying it, I broke out in a rash all over my arms and legs. I had to stop using it.”
Other Options for Pain Relief:
We discuss topical NSAIDs and a variety of other treatments for painful, inflamed joints in our Guide to Alternatives for Arthritis. Many nondrug options carry fewer side effects than NSAIDs.