At Bayer HealthCare Pharmaceuticals Inc., we are committed to providing the multiple sclerosis (MS) community with information to help ensure the safety of patients. Bayer has established a prospective pregnancy registry to study the maternal and infant pregnancy outcome in women who have taken BETASERON^® (interferon beta-1b) at any point before the time of conception and/or during pregnancy.

This Registry has been established to evaluate the safety of BETASERON use during pregnancy. Information from the Registry may assist clinicians and patients in making an informed decision should exposure to BETASERON occur around the time of conception or while pregnant.

Enrollment into The Betaseron Pregnancy Registry closed on July 31, 2011. Follow-up information on previously registered cases is still ongoing.

For more information about the Registry, please call (800) 478-7049.

INDICATIONS AND USAGE

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.

See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information.

For important risk and use information, please see the full Prescribing Information.

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.