If you suffer from afib, it may seem as though this difficult condition rules your life. From regular doctor’s office visits to strict medication routines and the constant worry over whether it’s all enough to keep a life-threatening stoke at bay, you likely feel as though you’re stuck in a never-ending cycle. But when a medication comes along offering a chance to break away from this restrictive routine, it may cause more harm than help, including potentially fatal side effects.
Motley Rice litigated cases for Pradaxa patients who suffered from serious side effects after taking the drug.
Pradaxa® Side Effects
Pradaxa, a blood-thinner made by manufacturer Boehringer Ingelheim for patients suffering from non-valvular atrial fibrillation (AF), was marketed as not requiring regular blood level monitoring, as with warfarin, and was instead prescribed in fixed dose regimens. Between its release in October 2010 and August 2011, more than 1 million prescriptions of the drug were dispensed to more than 370,000 patients.
In December 2011, however, the FDA released a safety announcement regarding reports of serious bleeding events in patients taking Pradaxa. Signs or symptoms of serious bleeding can include:
- bleeding that is severe or uncontrollable
- bruises that happen without a known cause or that get larger
- coughing up blood or blood clots
- menstrual or vaginal bleeding that is heavier than normal
- nose bleeding that happens often
- pink or brown urine
- red or black stools (looks like tar)
- unusual bleeding from the gums
- vomiting blood or vomit that looks like coffee grounds
On July 23, 2014, the British Medical Journal released the results of its investigation into Pradaxa, generically known as dabigatran etexilate mesylate, finding that the risk for major adverse bleeding events while taking the drug could be significantly reduced with regular blood plasma level monitoring. According to the investigation’s findings, "if the plasma levels of the drug were measured and the dose was adjusted accordingly, major bleeds could be reduced by 30-40% compared with well controlled warfarin."
The FDA issued a safety announcement in December 2011, which was later updated in November 2012, stating that it planned to evaluate post-market reports of serious bleeding associated with Pradaxa following a November 2011 warning issued by the European Medicines Agency (EMA). The EMA reported more than 250 cases of serious and even fatal bleeding complications associated with Pradaxa.
The FDA communication states that potential serious or even fatal bleeding is a known complication of all blood-thinning drugs, but the organization is working with Boehringer Ingelheim to conduct an ongoing safety review of serious bleeding events associated with Pradaxa.
The FDA also advises that "Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death."
Consult a medical professional before stopping or changing any medication.