The influx of injury reports to the FDA since Pradaxa was approved for the market has prompted the need for more reviews and studies. In the meantime, patients who are taking Pradaxa should be aware of the dangers this drug could pose, even under the supervision of a doctor's care.
Pradaxa was approved to treat atrial fibrillation, which occurs when the upper atria in the heart does not contract properly. Pradaxa acts as a blood thinner to enable blood to flow normally. Life-threatening blood clots may occur, causing a stroke.
The most serious patient complaints after taking Pradaxa include internal bleeding. This is especially true for patients with kidney disease and those over age 75. Untreated blood clots linked to Pradaxa have also led to pulmonary embolism and deep vein thrombosis in some patients. The risks that may occur should be balanced with the proposed benefits of taking Pradaxa.
Other conditions can become adversely worse with Pradaxa in a patient's system. While it is easy to recognize external bleeding, internal bleeding may go unnoticed until a condition worsens. Damaged skin from an abrasion or laceration is visible. Internal bleeding can occur from a blood clot compressing an organ such as the heart and preventing its proper function.
Generally, patients who take anticoagulant medications such as Pradaxa are more susceptible to internal bleeding when an artery or vein becomes damaged. Significant bleeding may occur from an injury or illness that seems minor, but worsens because of the medication.
Fractured bones can cause internal bleeding, particularly in older patients who may experiences falls. The structure surrounding the bone can tear when a trauma such as a fall occurs. The result can be massive internal bleeding.
Most understand the body can endure internal trauma after a car accident or a significant fall. Externally, the body might appear intact. Internally, compression to vital organs can cause serious injury and internal bleeding.
Car accidents, stomach ulcers or childbirth could also lead to internal bleeding. A mishap during a routine surgery could cause sudden internal bleeding in some patients. Complications can occur from different types of blood loss, but the rapid loss during trauma or surgery can be the most severe. These can lead to death. Additionally, the patient's physical size and other health conditions factor into the affects of complications.
A review of the reports received by the FDA concerning Pradaxa reveals nearly 1,000 serious injuries linked to the use of this drug. These all occurred during the first quarter of 2011, soon after the drug was released. Of these cases, 120 people died, 25 patients suffered permanent disability and over 500 patients were hospitalized because of issues with internal bleeding.
Further study may reveal that some patients are receiving excessive doses of Pradaxa. This could ultimately leads to serious internal bleeding and become fatal.