The FDA approved Pradaxa (also known as dabigatran) in October 2010 to reduce the risk of stroke in patients with atrial fibrillation, the most common type of heart rhythm abnormality. At the time, the drug label contained a warning about the risk of significant and sometimes fatal Pradaxa bleeding, but the risk was believed to be about the same as that associated with Warfarin, the most popular blood-thinning drug on the market.
Recent post-marketing reports raise concerns that the risk of Pradaxa side effects may be greater than previously believed, and may be putting patients in danger.
Reports of Pradaxa Side Effects
In the initial Pradaxa studies used to gain FDA approval, patients taking Pradaxa had fewer strokes than those who took Warfarin and the risk of Pradaxa bleeding seemed to be about the same. Pradaxa seemed to be a better alternative because, unlike warfarin, it did not require periodic monitoring with blood tests.
Recently, the FDA stated that it is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa. In fact, according to the Institute for Safe Medicine Practices, more than 500 reports of Pradaxa bleeding were submitted to the FDA in the first quarter of 2011.
One of the main concerns is that unlike patients who take Warfarin and suffer internal bleeding, patients on Pradaxa cannot have the effects reversed with vitamin K. Critics point to this lack of an antidote as particularly dangerous.
Pradaxa Bleeding Reported in Elderly Patients
In September 2011, New Zealand began a similar investigation into Pradaxa after five elderly patients died from internal bleeding and another 36 suffered Pradaxa bleeding and/or hemorrhaging. Japan also received reports of over 80 patients suffering from Pradaxa bleeding, and manufacturer Boehringer Ingelheim admitted that over 200 deaths may be attributed to Pradaxa side effects.
- Possible Pradaxa side effects may include the following:
- Internal bleeding and/or hemorrhaging
- Gastrointestinal problems
- Severe allergic reaction requiring hospitalization
- Myocardial infarction
- Easy bruising
Other indications of Pradaxa bleeding may include unusual bleeding from the gums, frequent nosebleeds, heavy menstrual or vaginal bleeding, and coughing up or vomiting blood. Those patients with kidney problems or a history of kidney disease may be at a higher risk of Pradaxa bleeding or other Pradaxa side effects. Patients over 75 years old may also be at risk if they have a history of stomach bleeding, stomach ulcers, or who take other medications that increase the risk of bleeding, such as aspirin, Plavix, Effient, or non-steroidal anti-inflammatory drugs (NSAIDs).
A study published in January 2012 in the Archives of Internal Medicine also suggests a potential link between Pradaxa and an increased risk of coronary events.
A Pradaxa Lawyer Can Help
If you or a loved one has suffered serious Pradaxa side effects, you may be eligible for a Pradaxa lawsuit. Contact a Pradaxa lawyer at Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.