Cataflam, Voltaren Heart Warning Issued by European Medicines Agency

European drug regulators warn that the active ingredient in the painkillers Voltaren and Cataflam, among others, could be linked to heart problems similar to those caused by the recalled drug Vioxx.  

On June 14, the European Medicines Agency (EMA) issued a press release recommending that Cataflam and Voltaren be approached with the same precaution toward cardiovascular risks as Vioxx.

The warning indicates that the side effects of Cataflam and Voltaren on the heart and circulation are similar to those of Vioxx and other drugs belonging to a family of medications known as selective COX-2 inhibitors. Vioxx was recalled in 2004, just two years after it was released due to heart risks.

Merck has paid $4.85 billion to settle Vioxx lawsuits filed on behalf of tens of thousands of individuals who suffered an injury after using the medication.  The lawsuits accused the drug maker of failing to warn patients about the potential Vioxx side effects, even though evidence suggested Merck was aware of the risks long before the recall was issued.

The active ingredient and medication of concern in Cataflam and Voltaren is diflofenac; one of the most widely used non-steroidal anti-inflammatory drugs (NSAIDs). A number of recent studies have linked NSAIDs in general, and diflofenac specifically, to an increased risk of heart problems.

NSAIDs are common pain medications often used to treat pain and inflammation. The first NSAID to be developed was Aspirin. The class of NSAID drugs are made up of medications such as ibuprofen and naproxen, common over-the-counter drugs available in most countries.

Common adverse effects of NSAIDs include gastrointestinal and renal problems, along with cardiovascular issues such as stroke myocardial infarction.

EMA Warns Certain Patients Away From Cataflam, Voltaren

According to the EMA warning: “Patients who have serious underlying heart or circulatory conditions, such as heart failure, heart disease, circulatory problems or a previous heart attack or stroke, should not use diclofenac.” 

The EMA also warned that patients with certain heart risk factors like high blood pressure, high cholesterol, diabetes and smoking should only use Voltaren and Cataflam after careful consideration.

The warning comes as the result of a review by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which has been reviewing the drugs since October 2012, in response to findings from previous studies.

In February, a study published in the medical journal PLoS Medicine found that Cataflam and Voltaren increased the risk of cardiovascular events between 38% and 63%. The researchers looked at a number of popular painkillers and found that Cataflam and Voltaren were ranked highest for cardiovascular risk compared to nonuse of an NSAID.