Lovaza's Labeling is Incomplete--Side Effects Not Accurate

Lovaza, a prescription medicine made with omega 3 fatty acids  has recently been associated with a higher risk of  bleeding complications including subdural hematomas.

The omega-3 fatty acids found in Lovaza are the same type found in fish oil. Research for dozens of years has pointed to a link between the intake of omega-3 fatty acids and a lower risk of cardiovascular disease that can cause premature death.

Research has also shown that omega-3 fatty acids have a number of other positive effects, such as decreasing triglyceride levels, slowing the growth of atherosclerotic plague, and slightly lowering blood pressure.

However, recent studies have shown that omega-3 fatty acids also inhibit the function of platelets. Platelets are part of the process that causes proper and healthy blood clotting.

When the platelets are inhibited, bleeding time can be prolonged and therefore more dangerous. Omega-3 fatty acid supplements, including Lovaza, inhibit the function of platelets in blood clotting, which puts patients at risk of extended Lovaza bleeding complications such as subdural hematomas.

For those suffering from a subdural hematoma, excess blood collects between the layers of tissue surrounding the brain. The outermost layer of this tissue around the brain is called the dura, and the layer beneath it is called the arachnoid.

Subdural hematoma causes bleeding between the dura and the arachnoid. While subdural hematoma bleeding is not inside the brain itself, it can still negatively affect the brain.

Bleeding accumulates and pressure builds, which puts an increasing amount of pressure on the brain from outside. This pressure, if allowed to reach a very high level, can cause unconsciousness and in some cases, death.

Treatment of subdural hematomas can range from simply monitoring the condition and waiting to brain surgery. In cases where there is too much pressure on the brain, surgeons may have to perform serious operations to relieve the dangerous pressure.

Lovaza’s label, approved by the FDA, includes a warning about increased Lovaza bleeding complications with omega-3 fatty acids.

According to the American Heart Association, patients who wish to treat coronary artery disease or high triglycerides with omega-3 fatty acids may not be able to intake as much as they need in a regular diet. Therefore, the AHA recommends at least one gram of fish oil per day for coronary artery disease patients, and at least two grams per day for hypertriglyceridemia patients.

People who took Lovaza or a similar omega-3 fatty acid supplement or fish oil and have since suffered a subdural hematoma may be able to file a Lovaza lawsuit. Drug manufacturers such as GlaxoSmithKline have a legal responsibility to adequately warn consumers about the potential side effects of using their drugs.