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Important Information for Betaseron® (interferon beta 1-b) Consumers Regarding Triad Group's Alcohol Prep Products
Date:1/8/2011

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,
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SOURCE Bayer HealthCare Pharmaceuticals
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