There are many lawsuits being filed against Boehringer Ingelheim related to Pradaxa internal bleeding. U.S. Food and Drug Administration has received around 300 reports of Pradaxa side effects in first three months after the approval of Pradaxa. Around 250 cases of death due to internal bleeding as a side effect of Pradaxa have been reported till now. Pradaxa internal bleeding lawsuits allege Boehringer Ingelheim of using flawed initial clinical trials to get approval for the drug. They are blaming that the pharmaceutical company has not done much research about its side effects before launching the blood thinning pill in the market.

Pradaxa is an anticoagulant drug. It contains Dabigatran as its main active ingredient. Dabigatran belongs to direct thrombin inhibitor group of drugs.  It prevents clotting in the blood. It is prescribed to patients who have clot problems or risk of blood clotting. It is prescribed to patients of heart disorder for prevention of blood clots and hence reducing the risk of stroke. Sometimes clots break free from their point of origin and circulated with the blood and can even move to a blood vessel of the brain, and block blood flow to the brain. Due to this strokes are caused. By preventing clots Pradaxa lowers risk of stroke in the patient. Blood clots could also travel to heart or lungs and could cause serious complications. Thus Pradaxa is used to reduce risk of blood clotting and other related serious health complications.

Pradaxa is being linked to several side effects, but internal bleeding is one of the most common side effects associated with use of Pradaxa. Internal bleeding could occur in any organ of the patient leading to fatal results. The lawsuits related to internal bleeding due to Pradaxa are highlighting how Pradaxa levels in the blood stream could lead to several serious problems. Pradaxa is usually prescribed to be taken twice daily, thus there is always a higher level of Pradaxa in the body. It is excreted through urine and thus there is involvement of kidney. Elderly patients are at higher risk of Pradaxa side effects as their kidney fubnction weakens with age. Patients with kidney problems or who have recently were operated are also at higher risk.

High level of Pradaxa in blood could lead to bleeding from any internal organ. There is no antidote available to reverse Pradaxa side effect or stop bleeding occuring internally due to use of Pradaxa. Doctor could transfuse more blood, but it is not a permanent option.

FDA is also investigating Pradaxa side effects as more adverse events related to Pradaxa bleeding are being reported. Though FDA maintains that it is of the view that health benefits are Pradaxa are important and its rate is high thus stopping use of Pradaxa is not a viable option as of now. It decreases the risk of stroke in patients of heart-rhythm disorder, thus stopping use of Pradaxa may increase risk of strokes in such patients.  But FDA has received so many cases of bleeding related to Pradaxa, so it needs to evaluate the drug. Bleeding occurring due to Pradaxa may lead to fatal consequences. FDA is evaluating whether bleeding incidence related to Pradaxa are more frequent and more than expected.

FDA evaluation could boost many cases against Boehringer Ingelheim related to bleeding due to Pradaxa use. It is believed that more cases will be filed in near future. Some of the post marketing studies also show that the original clinical trials had not involved patients with kidney problems. Patients with kidney diseases are at higher risk of bleeding. The pharmaceutical company may be in troubled water, as many more cases of Pradaxa side effects are being reported and there may be more lawsuits against the company in near future.