When a new drug is offered on the market, doctors have new hope for their patients. The initial reception for the blood thinner Pradaxa® was no different. Prescribed as a treatment for the side effects of atrial tachycardia,1 most commonly called non-valvular atrial fibrillation (Afib), Pradaxa has been the subject of a record number of FDA complaints.2
What is atrial flutter and atrial fibrillation (Afib)?
Many people do not know what atrial flutter is, nor do they know how it’s different from atrial fibrillation.3 4 Both atrial flutter and atrialfibrillation are types of tachycardia, which simply means irregular heart rate. In both atrial flutter and atrial fibrillation, the heart rate is fast and irregular. Both can result from serious medical issues. Patients with either atrial flutter or Afib may have had a history of any of the following:
- Congestive heart failure
- Rheumatic valve disease
- Congenital heart disease
- High blood pressure
- Thyroid problems
- Lung disease (such as emphysema)
- Heart surgery
The risks and long-term effects of Afib and atrial flutter can increase with age. The long-term affects of atrial flutter include stroke, blood clots, and heart failure.5
Atrial flutter ablation and Pradaxa
Treatments for Afib and atrial flutter focus on stopping blood clots and regulating heart rates. To correct heart rates, procedures such as atrial flutter ablation are considered. Atrial flutter ablation6 is a viable treatment when scar tissue in the heart is causing the atrial tachycardia. The treatment often involves the use of catherers and, in extreme cases, pacemakers. Afib and Atrial flutter ablation is generally used when medications and other treatments don’t work. One of those other treatments includes the use of blood thinners, like Pradaxa.
Side effects and complications of Pradaxa (dabigatran)
Manufacturers claim that there are no long-term effects for Pradaxa and other Afib/atrial flutter side effect treatments. However, manufacturers failed to test for certain conditions. In the case of dabigatran-containing Pradaxa, troubling side effects and serious complications have come to light. Specifically, the FDA does not recommend Pradaxa for patients suffering from non-valvular atrial fibrillation and heart valve implants.7 The complications and side effects8 linked to the Afib medication Pradaxa (dabigratran) include:
- Intracranial bleeding
- Gastrointestinal (stomach and intestines) bleeding
- Kidney problems
- Valve Thrombosis (blood clots in vessels/value of the heart)
- Heart attacks
Also concerning is the fact that stroke related to Afib is one of the things Pradaxa is supposed to combat. Patients had a higher risk of death and other serious complications from bleeding as a result of the antidote therapy for the dabigratran contained in the drug.
Long-rerm impact of Pradaxa
Since using Pradaxa (dabigatran) can cause serious side effects, these side effects can result in long-term problems for users. Pradaxa complications such as stroke can cause permanent damage and disabilities. Using Pradaxa may prolong bleeding or make it more difficult to control. Any resulting kidney damage can require alternative care such as dialysis. Heart attacks can cause irreparable damage to the muscles of the heart.
Treating non-valvular atrial tachycardia with Pradaxa can result in serious medical issues. If you or a loved one has experienced serious Pradaxa side effects or complications, contact your doctor to handle your medical concerns, but also contact a lawyer to make sure your legal rights and remedies are properly protected.