Thursday, May 17, 2012

What is Pradaxa and Its Side Effects

Pradaxa has been prescribed to several patients around the globe, according to medical resources.   Boehringer Ingelheim Pharmaceuticals, Inc. is the manufacturer of Pradaxa.  Even though Pradaxa is a helpful drug, there have been reports about the dangerous side effects of the drug.   Reports of abnormal bleeding among Pradaxa patients came out after the Food and Drug Administration (FDA) approved the drug in October 2010.   The agency later announced plans to look into the risks brought by Pradaxa.

 Pradaxa belongs to the class of medication named anticoagulants. It’s generic name is dabigatran etexilate mesylate. Anticoagualants are used for the prevention of harmful blood clots in the blood vessels.

 Most patients get Pradaxa for stroke prevention and blood clot averting with atypical heart rhythm (atrial fibrillation), which normally happens after an operation.   Two million Americans are suffering from atrial fibrillation. It involves rapid and random contractions of the heart’s atria, the two upper heart chambers.  It is one of the most common types of abnormal heart rhythm.

 According to Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, “people with atrial fibrillation are at a higher risk of developing blood clots, which can cause a disabling stroke if the clots travel to the brain.”

 Two drug safety announcements on Pradaxa were made by the FDA. The first was released on March 29, 2011, which centered on the proper storage of the drug.   The second one was issued on December 7, 2011 which covered the potential bleeding side effects of Pradaxa.

 It is essential for people taking Pradaxa to go to their doctor immediately, if signs of bleeding occur namely unusual bruising, presence of blood in the urine or stools, abnormal menstrual bleeding and vomiting blood. Few of the most common negative side effects of Pradaxa are indigestion, heartburn, and abdominal discomfort.

 Vision problems, slurred speech, excessive unusual bleeding, myocardial infarction, anaphylactic shock, gastroesophageal reflux disease (GERD), digestive tract ulcers are some of the more critical side effects of Pradaxa.

 Breathing difficulties, hives, rashes and swelling of some body parts are some of the allergic reactions that may be brought by Pradaxa.

 The above-mentioned Pradaxa side effects are not the complete list.  Those who opt to take Pradaxa and experience any of these manifestations are highly-encouraged to seek medical treatment immediately upon noticing the symptoms of any of these side effects.

References:

heart.emedtv.com/pradaxa/pradaxa-side-effects-p2.html
fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230241.htm
drugs.com/sfx/pradaxa-side-effects.html