Recall -- Firm Press Release
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Important Information for Betaseron® (interferon beta 1-b) Consumers
Regarding Triad Group’s Alcohol Prep Products
FOR IMMEDIATE RELEASE - Wayne, NJ, January 8, 2011 - Bayer HealthCare Pharmaceuticals has become aware of a broad United States market recall of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names. In the interest of patient safety, Bayer wants to ensure that U.S. patients and physicians using Bayer’s Betaseron are aware of the Triad recall.
The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria, Bacillus cereus, that could lead to life-threatening infections.
Triad alcohol prep pads packaged for use in the U.S. with Betaseron should not be used by patients. There is NO involvement or potential contamination of the Betaseron vial or other components in the Betaseron U.S. packaging. This issue is confined to the actual Triad alcohol prep products. Triad alcohol prep products are not used in Betaseron packaging outside of the United States.
Bayer instructs patients using Betaseron to immediately discontinue using the Triad alcohol prep pads included in the Betaseron packaging and dispose of those pads in the trash. When preparing to take their Betaseron injection, patients should use an alternative alcohol prep pad that is not subject to this Triad recall or use a sterile gauze pad in conjunction with isopropyl alcohol.
Bayer is currently in the process of gathering additional information from both Triad and the U.S. Food and Drug Administration. In the interim, Bayer has halted shipments of Betaseron to its distribution network, until it can affect a replacement for the alcohol prep pad. Bayer has posted this important information on its websites.
Further information on this Triad recall can be found on the FDA website at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm. If you have additional questions, please consult with your pharmacist or healthcare provider or contact BETAPLUS at 1-800-788-1467 option 1 to speak to a BETA Nurse. Or call Bayer at 1-888-84-BAYER, where operators will be available 24 hours a day to respond to questions from consumers or medical professionals. Members of the media should call Rosemarie Yancosek at 973/305-5213 or Rose Talarico at 973/305-5302.
Bayer will provide additional information when it becomes available.
BETASERON® (interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
IMPORTANT SAFETY INFORMATION
- BETASERON should be used with caution in patients with depression.
- Injection-site necrosis has been reported in 4% of patients in controlled trials. Patients should be advised of the importance of rotating injection sites.
- Severe hepatic injury, including cases of hepatic failure, has been reported. Patients should be monitored for liver enzyme elevations while taking BETASERON.
- BETASERON should be used with caution in patients with seizure disorders or cardiac disease.
- Female patients should be warned about the potential risk to pregnancy.
- Cases of anaphylaxis have been reported rarely.
- The most commonly reported adverse reactions are lymphopenia (low numbers of a certain kind of white blood cell), injection-site reaction, asthenia (general weakness), flu-like symptom complex (flu syndrome and/or a combination of at least two Adverse Events from fever, chills, muscle aches, tiredness and sweating), headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For important risk and use information please see the full Prescribing Information available at www.betaseron.com.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG. One of the world’s leading, innovative companies in the healthcare and medical products industry. Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.