Released to the public in 2010 by Boehringer Ingelheim, Pradaxa (dabigatran) is a prescription blood thinner (anticoagulant), commonly used to reduce the risk of stroke and blood clots for patients diagnosed with non-valvular atrial fibrillation (AFib). More than one million Pradaxa prescriptions were filled by pharmacies in the U.S. from October of 2010 to August of 2011. Recently, Boehringer Ingelheim released a statement linking Pradaxa to 260 fatalities caused by excessive bleeding between March 2008 and October 2011.
Safety warnings have been issued in Japan and Australia. All European doctors have been instructed by the European Medicines Agency to verify a patient’s optimal kidney health before considering a Pradaxa prescription. The FDA is currently investigating numerous incidents of dangerous hemorrhages and serious internal bleeding among Pradaxa users in the United States.
Common Side Effects
The investigation involves common side effects associated with Pradaxa including brain hemorrhages, kidney bleeding, internal bleeding, gastrointestinal bleeding and even death. Additionally, some Pradaxa users have experienced complications such as heartburn, nausea, gastrointestinal pain, and stomach irritation caused by the composition of the drug with the active ingredient in the pill’s outermost layer.
Pradaxa, unlike other blood thinners, does not require patients to take monthly blood tests. While vitamin K shots are used as blood-clotting agents when patients bleed internally, studies show these shots are ineffective with Pradaxa. Since Pradaxa users are not subject to regular tests, internal bleeding is more likely to go unnoticed or untreated. Consequentially, without any known counteracting drug, excessive bleeding in Pradaxa users can quickly escalate from serious to fatal.
Certain people are at a greater risk of complications, bleeding, and heart attack than others. Factors which increase the risk of Pradaxa use include: age 75+, preexisting issues of stomach bleeding or ulcers, preexisting kidney problems, and regular intake of other drugs which increase risks of bleeding, i.e. aspirin and non-steroidal anti-inflammatory drugs (NSAIDs).
Pradaxa users are advised to contact their doctors immediately if they experience any of the following symptoms: bloody phlegm or vomit, nose bleeds, abnormally heavy menstrual bleeding, pink or brown urine, and red or black stools. Also, it is important for Pradaxa patients to consult a doctor before ceasing to take their medication in order to avoid an increased risk of stroke.
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If you have suffered personal injury caused by Pradaxa, Shaw Cowart LLP offers the aggressive legal representation you need to help you protect your rights. In addition to Pradaxa, Shaw Cowart LLP lawyers have experience with mass tort claims involving Actos, Avandia, SSRIs, Yaz, Transvaginal Mesh Implants, and DePuy Hip Implants.