Pradaxa or, as it is known generically, dabigatran, was approved as an anticoagulant medication in October 2010 by the Food and Drug Administration (FDA).

Since that time, according to an article posted in January 2012 on www.webmd.com, a 33% increase in heart attack risk has been associated with the drug as compared to warfarin, an “old school” blood-thinner. Dangerous internal bleeding and Pradaxa use have also been linked.

In this same article, the increase in heart attack risk was identified as based on seven independent Cleveland-based clinical trials involving 30,514 patients.

A senior vice president of Pradaxa’s developing company, Boehringer Ingelheim, believes these results are based on small study size and are not big enough to be statistically significant.

Elderly May Experience More Problems with Internal Bleeding and Pradaxa Use

Problems with internal bleeding and Pradaxa use are more commonly connected in the public’s mind. Serious medical events (SMEs) involving internal bleeding and Pradaxa use are numerous, and they seem to affect the elderly disproportionately, according to an article also posted in January 2012 on www.philly.com.

Older patients taking Pradaxa are less likely to be monitored for blood levels of the drug in their system. Pradaxa and other new anticoagulants have been aggressively marketed on the basis of being better than Coumadin, also known generically as warfarin.

Supposedly, traditional weekly to monthly monitoring was not necessary with the newer class of blood thinners, so problems with dosing can be easily missed.

Elderly patients taking Pradaxa can also have poorer kidney function. While Pradaxa has an approved lower dose of 110 mg in other countries, a dose of 150 mg is the only available FDA-approved choice.

According to www.philly.com, this standardized dosing in a borderline kidney function patient (as opposed to a severe kidney impairment) can cause a build-up of the drug to unhealthy levels in the body.

Internal Bleeding and Pradaxa or Other Newer Line Blood-thinning Medications

While it must be noted that bleeding can occur on any blood-thinning medication, Pradaxa and other newer anticoagulants were released with no known remedy available to counteract their effect.

With tried and true anticoagulants like warfarin, it is known that a rapid induction of Vitamin K can reverse the thinning agent. This lack of remedy, and the alleged failure of the developers to post adequate warnings on the product, has led to numerous Pradaxa bleeding lawsuits.

Symptoms of Internal Bleeding and Pradaxa Use

Symptoms of internal bleeding and Pradaxa use may not be immediately obvious if you don’t know what they look like.  Here are some of them:

• Fatigue, weakness, lethargy
• Swelling of the extremities
• Passing dark black stools
• Nose bleeds occurring often
• Bruising that occurs easily and is excessive for injury or maybe without known injury
• Vomiting up phlegm or stomach contents that contains what appears to be coffee grounds
• Passing urine with an unusual tint
• Bleeding gums after flossing or brushing teeth

If you have suffered physical harm because of taking Pradaxa, you may qualify for a free consultation with a qualified expert attorney about ways to seek compensation.