The firm is recalling one lot of the drug, indicated to reduce the risk of stroke and systemic embolism in patients with NVAF.
Boehringer Ingelheim Pharmaceuticals, Inc. announced today that it is conducting a nationwide voluntary recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate), 75mg 60 US, NDC 0597- 0149-54, lot 201900, Exp January 2015. PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). The recall is limited to this one lot number.
This recall is being conducted due to a potential packaging defect on this lot that may compromise the bottle integrity. A damaged bottle could allow moisture to get into the bottle and, thus, may impair the quality of PRADAXA. As a consequence a patient may not receive a fully effective dose of PRADAXA 75mg, which would increase his or her risk of experiencing an ischemic stroke. This risk is small; however, not zero. Therefore, as a precautionary measure, PRADAXA is being recalled at the patient level.
Actions for patients with bottles of PRADAXA 75mg from lot 201900
Patients should continue to take the product as directed until they obtain replacement to assure there is no interruption of therapy.
We believe most of the potentially affected bottles have been returned, but if a person has or receives a bottle of PRADAXA 75mg from the potentially affected lot he/she should return the potentially affected bottle to their pharmacist as soon as possible for replacement at no charge.
Information has been sent to pharmacists alerting them of the details pertaining to this recall. As described in these recall communications, pharmacists who may have dispensed PRADAXA capsules to patients from manufacturing lot 201900 are instructed to contact those patients to return the product lot back to the pharmacy.
Distributors/retailers that have not received a recall packet should contact GENCO Pharmaceutical Services, 6101 North 64th Street, Milwaukee, WI 53218.
For information regarding this recall, please reference the following telephone numbers:
For technical product information or to report a technical product complaint, call 1-800-542-6257, option #3.
For information regarding the recall process, call GENCO Pharmaceutical Services at 1-877-319-8963.
About Pradaxa (dabigatran etexilate mesylate) Capsules
Indications and Usage
PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
IMPORTANT SAFETY INFORMATION ABOUT PRADAXA
PRADAXA is contraindicated in patients with active pathological bleeding and patients with a known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA.
WARNINGS & PRECAUTIONS
Risk of Bleeding
PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Promptly evaluate any signs or symptoms of blood loss, such as a drop in hemoglobin and/or hematocrit or hypotension. Discontinue PRADAXA in patients with active pathological bleeding.
Risk factors for bleeding include medications that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs). PRADAXA's anticoagulant activity and half-life are increased in patients with renal impairment.
A specific reversal agent for dabigatran is not available. Dabigatran can be dialyzed (removal of about 60% of drug over 2-3 hours) but data supporting this is limited. Activated prothrombin complex concentrates, recombinant Factor VIIa, or concentrates of factors II, IX or X may be considered but their use has not been evaluated. Protamine sulfate and vitamin K are not expected to affect dabigatran anticoagulant activity. Consider administration of platelet concentrates where thrombocytopenia is present or long-acting antiplatelet drugs have been used.
Temporary Discontinuation of PRADAXA
Discontinuing PRADAXA for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of stroke. Minimize lapses in therapy.
Effect of P-gp Inducers & Inhibitors on Dabigatran Exposure
The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided. P-gp inhibition and impaired renal function are major independent factors in increased exposure to dabigatran. Concomitant use of P-gp inhibitors in patients with renal impairment is expected to increase exposure of dabigatran compared to either factor alone.
For patients with moderate renal impairment (CrCl 30-50 mL/min), consider reducing the dose of PRADAXA to 75 mg twice daily when dronedarone or systemic ketoconazole is coadministered with PRADAXA.
For patients with severe renal impairment (CrCl 15-30 mL/min), avoid concomitant use of PRADAXA and P-gp inhibitors.
In the pivotal trial comparing PRADAXA to warfarin, the most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal (GI) events. PRADAXA 150 mg resulted in a higher rate of major GI bleeds and any GI bleeds compared to warfarin. In patients > 75 years of age, the risk of major bleeding may be greater with PRADAXA than with warfarin. Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions. These were commonly dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and GI ulcer). Drug hypersensitivity reactions were reported in <0.1% of patients receiving PRADAXA.
Other Measures Evaluated
In the pivotal trial, a higher rate of clinical myocardial infarction was reported in patients who received PRADAXA (0.7 per 100 patient-years for 150 mg dose) than in those who received warfarin (0.6).
For full PRADAXA prescribing information, please visit www.pradaxa.com
or contact Boehringer Ingelheim's Medical and Technical Information Unit at 1-800-542-6257.
About the Boehringer Ingelheim Cares Foundation Patient Assistance Programs
For more than 125 years, Boehringer Ingelheim has been focused on improving the lives of patients. In keeping with the company commitment to do the most good for the most people, Boehringer Ingelheim works hard to ensure its medicines are accessible to everyone who needs them, including senior citizens and families on limited incomes. The Boehringer Ingelheim Cares Foundation Patient Assistance Programs (BI-PAP) make Boehringer Ingelheim medicines available free of charge to patients who are without pharmaceutical insurance coverage, and who meet certain household income levels.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.
In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.
PRADAXA is a registered trademark of Boehringer Ingelheim Pharma GmbH and Co. KG and used under license.
RE-LY is a registered service mark of Boehringer Ingelheim International GmbH and used under license.