Betaseron (interferon beta-1b) is a medication approved by the FDA for the treatment of relapsing forms of Multiple Sclerosis, as a therapy to reduce the frequency of symptomatic exacerbations.
Berlex, Inc., the manufacturer of the medication, recently contacted healthcare professionals to remind them about certain aspects of the prescribing information for Betaseron as it relates to liver toxicity.
Reports have been filed during the post marketing safety surveillance indicating serious hepatic injury including autoimmune hepatitis and severe liver damage often resulting in hepatic failure and ultimately, if available, a liver transplant. Liver enzymes should be tested at regular intervals, the current recommendation being to do the test at one, three and six months, and regularly thereafter, following the initiation of Betaseron therapy.
In the initial weeks of Betaseron therapy flu-like symptoms are commonly reported following the start of the medication's use. Injection site necrosis (serious damage to the skin) has been reported in post marketing studies to occur in about 5% of those taking the medication in the first four months of therapy, and it has also been reported in some studies as occurring even after a year of treatment with Betaseron.
Further, during the clinical trials for interferon beta-1b, four suicide attempts were noted and one suicide with a fatal outcome was noted among those participating in the trials. Other common side effects include flu-like symptoms such as fever, chills, fatigue, muscle aches and sweating as well as swelling, redness, discoloration and pain at the injection site.
If you or a loved one is, or was, using Betaseron for relapsing MS and any of the problems noted above occurred requiring further medical intervention, please complete the form below.
Register your Betaseron ComplaintIf you or a loved one has suffered from liver failure, you may qualify for damages or remedies that may be awarded in a possible class action lawsuit. Please fill in our form on the right to submit your complaint and we will have a lawyer review your Betaseron complaint.
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