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Injured By Betaseron?
The FDA approved Betaseron on July 23, 1993. Betaseron is approved for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbation's. On April 22, 2005 healthcare professionals were warned regarding the prescribing information for Betaseron (interferon beta-1b) pertaining to hepatic toxicity.There have been reports during post-marketing safety surveillance of serious hepatic injury including autoimmune hepatitis and severe liver damage leading to hepatic failure and transplant. Liver function testing is recommended at regular intervals (one, three, and six months) following introduction to Betaseron therapy, and then periodically thereafter in the absence of clinical symptoms.
Flu-like symptoms are a common side effect associated within the initial weeks of taking Betaseron. Injection site necrosis [skin damage], which occurs in about 5% of patients during the first four months of therapy, has been reported in post-marketing studies even after a year of treatment.
During the clinical trial of interferon beta-1b, there were four suicide attempts and one completed suicide among those taking interferon beta-1b. Common side effects include flu-like symptoms (fatigue, chills, fever, muscle aches, and sweating) and injection site reactions (swelling, redness, discoloration, and pain).
If you or a loved one took Betaseron and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
BetaseronRSS Feed
Betaseron (interferon beta-1b) Hepatoxicity Reminder
Apr 22, 2005 | www.fda.gov
Berlex, Inc. reminded healthcare professionals of the prescribing information for Betaseron (interferon beta-1b) as it pertains to hepatic toxicity. Betaseron is approved for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations.There have been reports during post-marketing safety surveillance of serious hepatic injury including autoimmune hepatitis and severe liver damage leading to hepatic failure and transplant. Liver function testing is...
Betaseron
Quick Facts
Betaseron Reference Guide
Generic Name
Interferon beta-1b
Date Approved
July 23, 1993
Manufacturer
Chiron Corp.
Status
On the market
4/22/05 FDA warning
Approved Uses
Multiple Sclerosis
Serious Side Effects
Hepatic injury
Autoimmune Hepatitis
Severe liver damage
Skin damage
Related Topics
Defective Drugs
Interferon beta-1b
Date Approved
July 23, 1993
Manufacturer
Chiron Corp.
Status
On the market
4/22/05 FDA warning
Approved Uses
Multiple Sclerosis
Serious Side Effects
Hepatic injury
Autoimmune Hepatitis
Severe liver damage
Skin damage
Related Topics
Defective Drugs
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