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Drugs & Medical Devices

Lovaza May Cause Subdural Hematoma

— September 1, 2015

Lovaza, a popular prescription Omega-3 fish oil, may cause subdural hematoma. Omega-3s, essential for human health, may also contribute to increased risk of bleeding. As many who suffer from chronic subdural hematoma are elderly and, therefore, more likely to need Lovaza, this risk increases. To date, GSK’s warning does not include subdural hematoma.

Lovaza is prescription fish oil (Omega-3-acid ethyl esters). Combined with a healthy diet and exercise regimen, Lovaza may raise “good” cholesterol (HDL) and lower high triglyceride (fat) levels. In addition, Lovaza may cause subdural hematomas. The possibility of this Lovaza side effect never made it to the warning label.

Omega-3s, as their called, are necessary fatty acids if one wants to be a healthy human being. However, the human body doesn’t produce Omega-3s, so we have to seek other sources. The most popular include food sources, such as nut oils, plants and fish. We can also get Omega-3s from dietary supplements and prescription Lovaza. Personally, I take a vegan Omega-3 supplement because I can’t tolerate “fish burps.”

As a country, we spend a not-so-small fortune supplementing our diets with Omega-3s, more than $6B per year, and that’s just the food and dietary supplements. We spend another $916M on prescription fish oil, such as GlaxoSmithKline’s Lovaza.

While Omega-3s are important, it pays to know what you’re getting yourself into as well. Omega-3s sometimes increase bleeding risks, especially if you take three or more grams per day. If you already have a bleeding disorder or take medications, such as anticoagulants, blood thinners or drugs with a risk of bleeding, the risk from Omega-3s is even greater.

The current warning from GSK states: “Omega-3-acids may prolong bleeding time. Patients taking Lovaza and an anticoagulant or other drug affecting coagulation should be monitored periodically.”

Some people don’t think that warning is strong enough. They are among those who have reported cases of subdural hematoma after taking Omega-3s, such as Lovaza.

Subdural hematoma is a serious medical condition in which blood collects between the brain and the skull. They are not, per se brain injuries, but they can cause damage. Typically, head injuries are the cause of subdural hematoma; however, those with bleeding disorders may develop one after a relatively minor head trauma.

cllcasereportfig1Veterans and the elderly are most likely the ones to develop chronic subdural hematoma. In fact, The Journal of Neurosurgery estimates that chronic subdural hematoma will affect 60K U.S. patients every year by 2030. This is the time that a fifth to a quarter of the population will be over 65. This change will make chronic subdural hematoma the most common reason for brain surgery.

The symptoms of a subdural hematoma may take days or weeks to appear after the onset of bleeding. Age, medical conditions, medications and the size of the bleed also affect this time range.

Symptoms of subdural hematoma can include:

  • Headache
  • Confusion
  • Change in behavior
  • Dizziness
  • Nausea and vomiting
  • Lethargy or excessive drowsiness
  • Weakness
  • Apathy
  • Seizures

Treating subdural hematoma is always a trip to the hospital. They have access to more testing equipment than your primary care physician and if immediate surgery is called for, you’re already there. Treatment depends on the severity of the subdural hematoma:

  • If it’s small and symptoms are mild, observation may be the order.
  • Larger, more dangerous, subdural hematomas must be operated on to reduce cranial pressure.

If you’re experiencing these symptoms, seek medical help immediately.


Omega 3 Lovaza Lawsuit: Subdural Hematoma, Brain Bleeding Investigation

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