Updated September 2007-
The U.S. Food and Drug Administration (FDA) approved Avonex, also known as interferon beta-1a, in 1996 for the treatment of relapsing forms of multiple sclerosis. Multiple sclerosis (MS) is a chronic, often disabling, disease of the central nervous system that occurs when the protective sheath surrounding nerve fibers breaks down. Approximately 30 percent of MS
patients suffer from a relapsing-remitting form of the disease in which symptoms can diminish or disappear for months or years between flare-ups. Although the cause of MS is unknown, it is widely considered an autoimmune disease.
Avonex is a genetically engineered form of a naturally occurring protein in the body that is considered vital to immune functions. The medication slows the build-up of physical disability and decreases the frequency of exacerbations of MS. Avonex, injected into a large muscle (such as your buttock or hip) once a week, is made by Biogen Incorporated. In February 2003, Avonex was approved by the FDA as an early treatment for MS.
Side effects of Avonex include, but may not be limited to, flu-like symptoms, fever, fatigue
, chills, nausea
, vomiting and depression
.In February 2003, the FDA asked Biogen Inc. to notify physicians of the drug's link to two rare blood diseases. According to the FDA, a small number of Avonex patients have developed pancytopenia, a disorder in which bone marrow has difficulty making red blood cells, and thrombocytopenia, a persistent decrease in the number of blood platelets. Biogen, of Cambridge, Mass., plans to change Avonex's label to warn of the medication's link to the two disorders.
In March 2003, Biogen and FDA revised the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT INFORMATION, and CLINICAL STUDIES sections of the prescribing information to include important new safety information and a patient Medication Guide. Updated safety information includes a cautionary note regarding use in patients with depression and other severe psychiatric symptoms.
Post-marketing reports of depression, suicidal ideation and/or development of new or worsening of pre-existing psychiatric disorders, including psychosis, and reports of anaphylaxis, pancytopenia, thrombocytopenia, autoimmune disorders of multiple target organs, and hepatic injury manifesting itself as elevated serum enzyme levels and hepatitis were added to the labeling.
An FDA-approved Patient Medication Guide, providing important patient safety information and comprehensive instructions for patient self-administration of Avonex, was added.
In March 2005, FDA and Biogen notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS/Drug Interactions and ADVERSE REACTIONS/Post-Marketing Experience sections and Medication Guide. Severe hepatic injury, including cases of hepatic failure, has been reported in patients taking Avonex. Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge. In some cases, these events have occurred in the presence of other drugs that have been associated with hepatic injury. The potential risk of Avonex used in combination with known hepatotoxic drugs or other products (e.g. alcohol) should be considered prior to Avonex administration, or when adding new agents to the regimen of patients already on Avonex.
In 2007, the
Institute for Safe Medication Practices and the Division of Public Health
Sciences, Wake Forest University School of Medicine, conducted a longitudinal
Adverse Events Reporting System Review
of the U.S.
FDA's most dangerous drugs
The study found interferon beta to be one of the most
dangerous drugs on the market with some of the highest number of
deaths. Interferon beta was the eighth deadliest drug, according to the FDA
reports. Over the eight years of the study, interferon beta was found to
have over 1,100 deaths in an 8-year period.
Interferon beta was also the fourth highest tally in the study in serious drug outcomes or disability. According to FDA reports, there were over 8,300 adverse drug incidents involving interferon beta.
See your doctor if you have experienced serious side effects associated with Avonex. In addition, it may be important to contact an attorney
who can help you protect your legal rights. Please keep in mind that there may be time limits
within which you must commence suit.
- Multiple Sclerosis Drugs
- Blood Disorders: Overview
- Depression: Overview
- Fatigue: Overview
- Liver Failure: Overview
- Nausea: Overview