FDA approves first anti-inflammatory drug for cardiovascular disease

“We have known for a number of years role of inflammation in the development of plaque buildup in the arteries,” says Dr. Brett Nowlana cardiologist with Hartford HealthCare Heart & Vascular Institute.

“Until this new approval of colchicine, we had no cardiac drugs to specifically address this risk.”

Nowlan also explains that the anti-inflammatory mechanisms at work in colchicine are different from other medications such as steroids or NSAIDs such as aspirin.

“It is a pill intended to be taken once a day and is a long-term preventive medication. It would be added to any other risk-reducing medication, such as aspirin or statins, and would not replace the use of these,” he notes.

“Although we have long suspected that inflammation plays a major role in the development of coronary disease, it was only in the last 10 years that larger trials has come out that showed how useful an anti-inflammatory agent such as colchicine could be in reducing cardiovascular risk in patients with heart disease,” says Dr. Cheng-Han ChenPhD, interventional cardiologist and medical director of the Structural Heart Program at MemorialCare Saddleback Medical Center in Laguna Hills, California.

“The drug works through multiple pathways to decrease the activity of our various types of inflammatory cells. By doing so, it has been shown to reduce such serious risks as heart attack and stroke,” says Chen.

“Interestingly, colchicine is not a new drug,” says Chen.

“It has been used widely for various inflammatory conditions throughout the body, such as arthritis and hepatitis,” says Dr. Chen. Nowlan adds that it is also used for pericarditis, or to reduce inflammation of the fibrous sac lining around the heart.

“The reason this FDA approval is such a game changer is that we now believe it can be very useful in cardiovascular disease, particularly in patients we already treat with our entire arsenal of effective cardiac medications such as statins,” Chen tells Healthline.

“We now have a way to treat the disease through a different angle that we’ve never used before, which is by attacking underlying inflammation,” says Chen.

“With colchicine, we now have a unique way to lower cardiovascular risk that adds to and complements other medications that we currently use,” Nowlan says. These treatment results from the study compare very well with other drugs we use, he adds.

“As with all medications, colchicine is not right for everyone,” says Nowlan. “The most common side effect with this medication is gastrointestinal upset.”

“There are also uncommon but known effects of colchicine to lower blood cell counts and cause muscle weakness,” he says.

“(Colchicine) can also interfere with levels of medications such as some antifungal and antibiotic medications,” adds Nowlan.

Common side effects reported in clinical studies according to the FDA:

• Diarrhea
• Abdominal cramps
• Muscle pain or myalgia

Serious side effects, including death, are associated with taking more than the recommended dose. Colchicine overdose can lead to the following:

• Abdominal pains
• Muscle numbness and weakness (ie, neuromuscular toxicity).
• Vomiting
• Low blood cell count (ie, low red blood cell count, low white blood cell count, and low platelet count, all of which can be life-threatening and can lead to death).
• Kidney problems
• Skin problems, including rashes and alopecia (hair loss)
• Fatal overdoses in adults and children

FDA says to keep colchicine out of reach of children.

Nowlan tells Healthline that the approval of colchicine also highlights the importance of inflammation as a risk factor for heart disease and should encourage everyone to make lifestyle choices that can help lower inflammation. He says these include:

• Stop or avoid smoking
• Eat more whole and unprocessed foods
• Consumes less sugar
• Participation in regular physical activity
• Sheepsufficientsleep