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Written by Administrator
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Monday, 19 July 2010 16:13 |
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Coumadin 1 mg Tablet Blister Packs: Recall AUDIENCE: Hematology, Cardiology, Risk Manager ISSUE: Bristol-Myers Squibb determined that some of the tablets, over time, may not meet specification for isopropanol. Isopropanol is used to maintain the active ingredient, Coumadin, in the crystalline state, and could affect the therapeutic levels of the active ingredient. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and if there is too much active ingredient, there is an increased risk of bleeding. The following lot numbers are included in this recall: Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012; HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012. BACKGROUND: The recall only involves Coumadin 1 mg tablet blister-packs distributed in the U.S. This recall does not involve Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product. Patients who may have product from the subject lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted. RECOMMENDATION: See the company Press Release for additional contact information. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: - Online: www.fda.gov/MedWatch/report.htm
- Phone: 1-800-332-1088
- Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
- Fax: 1-800-FDA-0178
[07/12/2010 - Press Release - Bristol-Myers Squibb] |
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Last Updated on Monday, 19 July 2010 16:27 |
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Welcome to the American APS Association |
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The American APS Association would like to thank you for visiting. Awareness and patient education of antiphospholipid syndrome are two very important parts of the mission of the AAPSA. When you share this site and the information found here with others, you help make a difference. Antiphospholipid Syndrome is one of the newest and fastest growing autoimmune disorders today. Unfortunately, it is also one of the least known and understood by the general public and medical community. Many APS patients struggle for years without a diagnosis wondering why they suffer with the symptoms that affect them daily. Once diagnosed, finding the information they need to help them understand their new diagnosis can be nearly impossible. As patients, we have partnered with some of the world renown physicians that have dedicated their lives to the study and treatment of antiphospholipid syndrome and the antibodies themselves. The result is the non-profit American APS Association. Our mission is awareness, education, research and support. Most patients had never heard of APS until their diagnosis. Education is a must. Though we have great support system in our families and friends, we all need to talk to someone who truly understands from time to time. Awareness, education, research and support. Please visit this site regularly as we update and build to bring you the most accurate and up to date information. |
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Last Updated on Wednesday, 02 June 2010 21:20 |
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In Memory of Robert Desbecker |
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May 31, 1929- May 10, 2010Robert Desbecker was a longtime resident of Beechwood Nursing Home where he was lovingly named "Deputy Mayor." In New York, he attended Buffalo's Olmstead Elementary and Bennet High School. He graduated from Hobart College majoring in Business and Music. His love for all music and entertainment genres led him to a career in the sales and distribution of records and audio equipment. He also loved swimming, art galleries, the BPO, and playing bingo. He was a wizard at song lyrics and playing music by ear, a love that he shared with his family. His sarcastic sense of humor was loved by all. Robert lost his young son, Arnold, at age 19 to Catastrophic Antiphospholipid Syndrome. As seen in many family with auto-immune disorders, APS has been diagnosed in other family members, including Robert and his daughter. His family is dedicated to awareness of Antiphospholipid Syndrome. |
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Last Updated on Wednesday, 02 June 2010 21:52 |
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13th International Congress on Antiphospholipid Antibodies - Patient Perspective |
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The 13th International Congress on Antiphospholipid Antibodies was held in Galveston, Texas April 13-16, 2010. Hosted by Chairperson Dr. Silvia Pierangeli, and co-chair Dr. Robin Brey,MD the congress was attended by hundreds of the physicians that dedicate their work to treating and studying antiphospholipid syndrome and the antibodies themselves. Several representatives of the American APS Association were in attendance. We rolled up our sleeves and immediately began serving by stuffing bags and moving boxes. While it may sound tiring and far from glamorous, it was quite an honor to help those that work so hard to give us relief and search for the cure. Being a part of early registration gave us an opportunity to get to know the staff of the Continuing Education Department of the University of Texas Medical Branch. They welcomed us with open arms and immediately treated us like part of the family. |
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