Interferon beta-1b Side Effects

Brand Names: Betaseron

Please note - some side effects for Interferon beta-1b may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Interferon beta-1b - for the Consumer

Interferon Beta-1b Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Interferon Beta-1b Solution:

Constipation;changes in menstrual cycle; diarrhea; dizziness; drowsiness; flu-like symptoms (eg, low-grade fever, chills, general body discomfort); frequent urination; headache; joint pain; muscle pain or weakness; nausea; redness, pain, or swelling at the injection site; stomach upset; sweating; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue-black discoloration or skin breakdown around the injection site; chest pain; confusion; fast or irregular heartbeat; feeling cold or hot all the time; infection; mood or mental changes (eg, depression); persistent or high fever; seizures; severe anxiety or nervousness; severe headache or dizziness; severe stomach pain; suicidal thoughts or behaviors; unexplained swelling or weight gain; unusual bruising or bleeding; yellowing of the eyes or skin.

Side Effects by Body System

General

The use of interferon beta-1b in patients with multiple sclerosis is limited, therefore, it is probable that rarely occurring adverse effects may not have been reported to date.

Other

A flu-like syndrome, which includes fever, chills, myalgias, malaise or sweating, occurs in 50% of patients. This syndrome appears to occur most frequently during the first three months of therapy, and abates with continued treatment.

Local

Locally, interferon beta-1b injections may cause pain or inflammation at the injection site in 70% of patients. Severe necrotic lesions have occurred.

Hepatic

Hepatic effects of interferon beta-1b include transient elevation of liver function tests. Mild elevations have occurred in 11% of treated patients. Therapy has been discontinued in 1.2% of patients for abnormal liver enzymes.

Hematologic

Hematologic effects include mild neutropenia in 17% of patients receiving interferon beta-1b. Lymphopenia occurs at some time in up to 80% of treated patients.

Genitourinary

A 19-year-old white woman diagnosed with multiple sclerosis experienced severe vaginal bleeding when her dose of interferon beta-1b was increased, 1 month from the start of therapy, from 4 to 8 million intl units.

Effects on the genitourinary system include menstrual disorders in 13 to 28% of women treated with interferon beta-1b.

Cardiovascular

Cardiovascular effects of interferon beta-1b may include palpitations in 8% of treated patients, and less commonly, tachycardia and hypertension.

Nervous system

The nervous system may be adversely affected by interferon beta-1b administration. Somnolence, depression, anxiety, and confusion have been reported in 4% to 6% of patients. One suicide and four suicide attempts were reported in 372 patients treated with 1.6 or 8 million intl units every other day, while none were reported in patients on placebo.

Gastrointestinal

Gastrointestinal adverse effects may include nausea and vomiting.

Other

Sudden hearing loss, which was reversible within 7 to 14 days of drug discontinuation, has been reported.

Immunologic

Immunologically, some patients may develop antibodies against interferon beta, often as early as 3 months after the start of treatment. The antibodies may bind to and block the beneficial effect of interferon beta in MS. The overall clinical significance is unknown.

Results of a prospective study suggest that several autoimmune events may occur during interferon beta treatment of multiple sclerosis and recommends the close monitoring of thyroid, liver function and autoantibodies.

Neutralizing antibodies formation occurred after the 24-week treatment in 95% of patients treated with natural interferon beta compared to 27% of patients treated with recombinant interferon beta.

Dermatologic

A case of sarcoid-like dermatitis is reported in a 57-year-old white man diagnosed with multiple sclerosis. The cutaneous eruption that developed 2 months after initiation of interferon beta-1b therapy histologically resembled sarcoidal granulomas, but without distinctive features of true sarcoidosis.

A case of cutaneous necrosis in a 38-year-old woman diagnosed with relapsing-remitting multiple sclerosis is believed to be a result of an immunological response to the improperly dissolved lyophilized drug. The patient was rechallenged with the drug, after introducing changes to the way she reconstituted the drug, without any reports of scars.

Dermatologic side effects have included contact dermatitis, erythema nodosum, exfoliative dermatitis, furunculosis, hirsutism, leukoderma, lichenoid dermatitis, maculopapular rash, psoriasis, seborrhea, benign skin neoplasm, skin carcinoma, skin hypertrophy, skin necrosis, skin ulcer, urticaria, and vesiculobullous lesions.

Endocrine

Endocrine side effects have included changes in thyroid function.

Musculoskeletal

Musculoskeletal side effects reported in a study of 124 multiple sclerosis patients have included reports of myalgia (44%) and myasthenia (13%). A study of 19 patients with primary progressive multiple sclerosis reported frequent and clinically significant increase in spasticity that appeared approximately 2 months after start of interferon beta-1b.

Renal

Renal side effects have included postmarketing case reports of hemolytic uremic syndrome, and nephrotic syndrome with minimal histologic changes of the glomerulus. Upon withdrawal of interferon beta therapy these side effects subsided.

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