Authored by Gloria Mayer
Common Pradaxa side effects have been identified, including:
Researchers have also linked Pradaxa with these serious conditions:
Pradaxa is an anti-coagulant, often referred to as a blood thinner. While all blood thinner medications have a risk of internal bleeding, others like Coumadin (warfarin) can be effectively treated with “reversal agents.” With Pradaxa, there is no reversal agent to stop the bleeding – which can have life-threatening consequences.
The maker of Pradaxa faces liability because they did not warn patients of this risk.
The drug was FDA approved in 2010. By 2012, over 17,000 people reported adverse side effects in which Pradaxa was the primary suspect drug, according to the FDA database. The most commonly reported Pradaxa side effects were internal bleeding, indigestion, and hemorrhage. Also, 6,249 hospitalizations and 1,847 patient deaths were determined to be due to Pradaxa.
A report issued by the Institute for Safe Medicine Practices’ QuarterWatch on October 3, 2012 estimates that prescription drug complaints to the FDA have risen 90% in the past 4 years, and two drugs, Pradaxa and Chantix, are responsible for 37% of that increase.
If you or a loved one suffered internal bleeding after taking Pradaxa, it is important to take action and learn about your legal rights. You may be entitled to significant compensation. You can speak with a lawyer right now and get your questions answered. Contact DrugRIsks.
Early Pradaxa research was conducted in the RE-LY clinical trials, which were the basis for FDA approval. Some researchers now suggest that only certain results of the trials were made public, while safety risks were not disclosed.
Within weeks of the FDA’s approval of Pradaxa, further research by MedWatch showed the agency had received more reports of Pradaxa side effects compared to 98% of other drugs on the market. Complaints included internal bleeding in the brain, intestines and kidneys, as well as heart attacks.
On December 7, 2011, the FDA announced that it would review the safety of Pradaxa after receiving reports of internal bleeding in the brain, intestines and kidneys, as well as heart attacks.
In 2012, The Journal for The American Medical Association (JAMA) warned that the FDA may have rushed approval of the drug, ignoring specific serious Pradaxa side effects like internal bleeding.
The European Medicines Agency also issued a warning on internal bleeding risks.
On June 6, 2012, the Philadelphia Inquirer reported that Pradaxa led all other medications in 2011 for number of deaths and internal bleeding episodes reported to the FDA. Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has also warned that they may withdraw recommendations that the government allow prescriptions of Pradaxa.
In the U. S., experts disagree about the safety of Pradaxa. In November 2012, the FDA updated its warnings stating that, for now, testing shows Pradaxa carries the same risks as warfarin and Coumadin. However, the American College of Cardiology has warned that Pradaxa use can significantly increase the risk of bleeding complications compared to warfarin.**
Recently, the Institute for Safe Medication Practices ranked anticoagulants like Pradaxa among the most dangerous of outpatient drugs and noted that FDA reports show bleeding caused by Pradaxa is nearly 5 times as likely to result in death than with warfarin.
In the United States, Boehringer Ingelheim faces thousands of lawsuits from patients affected by Pradaxa side effects. A federal judge recently blocked attempts by the company to dismiss victims’ cases.
People who suffered internal bleeding while taking Pradaxa can file lawsuits against the manufacturer. Experts fear thousands of patients may ultimately suffer serious Pradaxa side effects.
If you or a loved one has suffered from Pradaxa side effects, it is your right to seek legal counsel.
Lawyers are helping victims file claims against the manufacturer. Due to the number of lawsuits expected, the cases have been consolidated to a special federal court in Illinois. A lawyer can let you know what compensation is available and how long you have to take action.
In seeking legal counsel, make sure your lawyer is experienced in fighting large drug companies. This type of lawsuit is complex, and requires a qualified attorney with the resources to complete this case. The DrugRisks Resource Center only recommends law firms that specialize in Pradaxa lawsuits.
For more information on the side effects, warnings and legal action related to the drug Pradaxa, or to speak with a lawyer, contact us today. We are available 24 hours a day to provide help.