Pradaxa Lot Recalled Due To Packing Issue

The prescription drug PRADAXA is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., a large German pharmaceutical company, and is a blood thinner used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Due to a packaging issue with a single lot of the drug, the effected bottles could be damaged that may allow moisture to get into the bottles that could effect the quality of the drug. As a result, the patient may not receive his/her full intended dosage of Pradaxa and thereby be at an increased risk of suffering an ischemic stroke. The voluntary recall is intended to eliminate this small risk. The particular lot subject to the recall is labeled 75mg 60 US, NDC 0597- 0149-54, lot 201900, Exp January 2015.

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PRADAXA (Dabigatran) is used to help prevent strokes or serious blood clots in people who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) without heart valve disease. Dabigatran is in a class of anticoagulant medications (”blood thinners”) called direct thrombin inhibitors. Dabigatran works by preventing blood clots from forming in the body.

The side effects of taking Pradaxa may include stomach pain, heartburn, and nausea, and more serious possible side effects may include unusual bruising or bleeding; pink or brown urine; red or black, tarry stools; coughing up blood; vomiting material that is bloody or looks like coffee grounds; bleeding from the gums; frequent nosebleeds; heavy menstrual bleeding; bleeding from a cut that lasts longer than normal; joint pain or swelling; headache; dizziness; weakness; hives; rash; itching; difficulty breathing or swallowing; and, swelling of the arms, hands, feet, ankles, or lower legs.

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Pradaxa was approved by the FDA in 2010 for patients with irregular heartbeat. Pradaxa was intended to replace the older blood-thinning drug Coumadin (warfarin) that requires weekly medical exams and dietary restrictions. Warfarin’s side effects include brain hemorrhages and other types of internal bleeding.

Sales of Pradaxa were in excess of $1 billion in 2011 (its manufacturer spent $464 million in 2011 to market Pradaxa, often directly to consumers). Pradaxa is the subject of many product liability lawsuits filed throughout the United States. There were 3,781 adverse effects and 542 deaths associated with Pradaxa that were reported to the U.S. Food and Drug Administration (“FDA”) during 2011, which surpassed adverse effects reports and death reports for all other monitored drugs in 2011. As a result, the FDA is conducting a safety review of Pradaxa.

In January, 2012, a study of Pradaxa by the Cleveland Clinic found that Pradaxa may increase patients’ risk of heart attack and cause irreversible bleeding complications.

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If you or a loved one took Pradaxa and may have suffered a side effect, injury, or other harm as a result, you may be entitled to compensation for your losses due to your use of Pradaxa. You should promptly contact a local drug claim attorney to discuss your possible Pradaxa claim.

Click here to visit our website or telephone us on our toll-free line, 800-295-3959, to be connected with medical malpractice lawyers in your state who are handling Pradaxa product liability claims.

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This entry was posted on Friday, November 9th, 2012 at 11:07 am. Both comments and pings are currently closed.

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