TORONTO — The nonsteroidal anti-inflammatory drug (NSAID) diclofenac – Voltaren, a drug that is frequently used for the treatment of pain and inflammation. It is associated with  significantly increased risk of cardiovascular complications and should be removed from essential-medicines lists (EML), according to a new review


Voltaren, which is listed on the EML of 74 countries, increased the risk of cardiovascular events between 38% and 63% in different studies. The increased risk with diclofenac was similar to the COX-2 inhibitor rofecoxib (Vioxx, Merck), a drug withdrawn from worldwide markets because of cardiovascular toxicity…


Taking flightThe thing with diclofenac is that even in small doses it increases the risk of cardiovascular events. Dr David Henry

 In the review, published online February 12, 2013 in PLoS Medicine, Henry and McGettigan showed that in 15 countries, a list comprising high-, medium-, and low-income countries, diclofenac was the most widely used NSAID. It has a market share roughly equal to the combined market share of ibuprofen, naproxen, and mefenamic acid. The high-risk NSAIDs, diclofenac and etoricoxib, had one-third of the market share across the 15 countries.

Diclofenac, Even in Small Doses, Can Cause Problems

The meta-analysis by McGettigan and Henry also reviewed the relative cardiovascular risks of NSAIDs in observational and randomized studies. Rofecoxib, etoricoxib, and diclofenac were the three agents that were consistently associated with a significantly increased risk when compared with nonuse. Rofecoxib increased the risk of serious cardiovascular events between 27% and 45%, and etoricoxib increased the risk more than twofold compared with nonuse. In two observational studies, diclofenac increased risk of acute heart attack approximately 38% and 39%, respectively, and increased the risk of cardiovascular events 40%. In one randomized trial, diclofenac was associated with a 63% increased risk of cardiovascular events compared with nonuse.

Henry said the NSAIDs are very familiar drugs for physicians and because of such familiarity might be casually prescribed. While the drugs are available over the counter, the cardiovascular risks are associated with the prescription strengths of NSAIDs. For diclofenac, the prescription dose ranges from 100 to 150 mg per day, and this dose is high enough to cause a risk of cardiovascular events, with higher doses associated with even greater risks. “The thing with diclofenac is that even in small doses it increases the risk of cardiovascular events. The average dose that is used and marketed is quite high.”


If you have heart disease and are taking diclofenac, do stop the medication and then go talk to your doctor about an alternative. Dr David Henry


Steg noted that a study published last year in Circulation,  showed that the use of NSAIDs was associated with a persistently increased risk of coronary events in patients with a previous heart attck. In more than 43 000 heart attack patients treated with NSAIDs, their use was associated with a 59% increased risk of death after one year and a 63% increased risk of death after five years of use. In addition, the use of the NSAIDs was associated with an increased risk of coronary death and recurrent MI.

“I think this is a completely underappreciated problem,” said Steg. “Most physicians would not be alert to the long-term use of these agents. Many of these agents are over the counter, so physicians are not necessarily aware of their use. Also, they may be used fairly frequently by patients and for very long periods of time. In the elderly, because of bone and joint issues, their use is very common.”

 Gastro intestinal Ulceration

Dietary administration of diclofenac to mice and rats at doses up to 0.5 mg/kg/day revealed no carcinogenic activity. However, the plasma concentration of diclofenac at this dose level was 20 to 100 times lower than that in humans. Administration of higher doses to rats and mice resulted in increased mortality due to gastrointestinal ulceration.


Nepean Naturopathic Centre – making health easy


[metaslider id=2529]