Risk/Benefit Analysis of Pradaxa? Too Much Risk for Patients!

In late 2010, the FDA approved the drug called Pradaxa (dabigatran); manufactured by Boehringer Ingelheim. Pradaxa is a blood thinner and is supposed to be prescribed to patients who suffer from the cardiac disorder atrial fibrillation.

Atrial Fibrillation is the most common form of abnormal heart rhythm.  Patients who suffer from Atrial Fibrillation or A-Fib as doctors call it; have inconsistent electrical activity in their heart causing the upper chambers to beat irregularly and too frequently.  As a result, the heart does not beat efficiently and blood can pool in the upper chambers.  When blood pools, it can cause clots to form which increase the patient’s chance of suffering a debilitating stroke.

The use of blood thinners to treat patients with A-Fib is the standard of care in the medical community.  Almost everyone knows a relative or friend who has taken Coumadin. Coumadin has been the “go-to” treatment for patients with A-Fib for many years.  The problem with taking Coumadin is that patients must see their doctor frequently to have lab work done in order to monitor their blood clotting factors. Neither patients nor doctors like the need for very frequent blood work and vigilante monitoring of patient clotting factors.

Generally, the foremost risk for patients who take blood thinners is what happens when they have a bad accident or if they need emergency surgery.  Since their blood does not clot normally, they run the risk of excessive and dangerous bleeding unless they receive emergency medical attention.  Fortunately, for those on Coumadin, doctors can quickly and effectively reverse the blood thinning effect by administering Vitamin K or packed red blood cells.  After this treatment, the patient can safely undergo surgery and life threatening bleeding can be controlled.

Pradaxa is significantly different than Coumadin in one very important aspect.  It is impossible to emergently reverse the blood thinning effects of Pradaxa, until the drug has completely cleared the patient’s body.  Therefore, if a patient who is on Pradaxa has a bad accident or needs emergency surgery, they are out of luck.  Many will simply bleed to death and there’s nothing their doctors can do to stop it.

To compound the danger, it appears that physicians are prescribing Pradaxa for general anticoagulation and not just to treat Atrial Fibrillation.  This is commonly referred to as “OFF LABEL” use.  The Institute for Safe Medication Practices has reported that doctors are prescribing Pradaxa for off label use twice as often as they are to reduce the risk of stroke. This off label use is likely related to the drug maker’s marketing efforts and oversimplification of the dangers for Pradaxa use.

In addition to the risk of irreversible, uncontrolled bleeding, evidence is developing that Pradaxa is even more dangerous in patients who have impaired Kidney function.  Since Pradaxa is eliminated from, the body though the kidneys, if a patients kidneys are not working properly, abnormally high levels of Pradaxa can remain in the body.  When this occurs, any bleed a patient suffers, even something as simple as an ulcer, can be life threatening.

Clinical researchers at the Cleveland Clinic have recently published the results of a study conducted on Pradaxa that reveals additional dangers associated with the drug’s use. Dr. Ken Uchino and Dr. Adrian Hernandez, at the Cleveland clinic, have reported that the risk of acute coronary syndrome (heart attack) is greatly increased in patients using Pradaxa.

Lastly, Pradaxa has a very short shelf life and must be used within 60 days after it is dispensed.  Some pharmacists are very concerned that patients will use the drug after its expiration date.  Even doctors who conducted the most recent scientific studies on Pradaxa have been quoted as saying that they were completely unaware of the fact the drug expired so soon after being dispensed.

Pradaxa’s manufacturer disputes the results of the Cleveland Clinic study, as well as all the other dangerous finding being linked to the drug:

“We have done the analysis and feel there is still a very favorable risk/benefit profile for the drug as prescribed in clinical practice,” said the company spokesman, Dr. John Smith.

The view of the “risk/benefit” analysis from a drug maker’s perspective is usually starkly different than the risks a patient or their physicians are willing to take with a patient’s health or mortality.

Before you take this drug, ask your doctor about the risks and always read the warning labels very carefully.