BEBULIN VH SIDE EFFECTS
- Generic Name: factor ix complex intravenous administration
- Brand Name: Bebulin VH
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The following adverse reactions were reported in clinical studies with a previous formulation of BEBULIN:
Hypotension, Dizziness, Urticaria, Erythema, Pyrexia, and Chills.
The formation of inhibitor antibodies to Factor IX has been observed with the administration of BEBULIN.
Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.
Table 1 lists the adverse reactions reported during postmarketing use of BEBULIN.
Table 1: Postmarketing Adverse Reactions
|Blood and Lymphatic System Disorders
|Disseminated intravascular coagulation
|Immune System Disorders
|Anaphylactic/Anaphylactoid reactions, Hypersensitivity
|Nervous System Disorders
|Thromboembolic events (including Deep vein thrombosis, Pulmonary embolism, Thrombotic stroke), Flushing
|Respiratory, Thoracic, and Mediastinal Disorders
|Dyspnea, Bronchospasm, Wheezing, Cough
|Abdominal pain, Nausea
|Skin and Subcutaneous Tissue Disorders
|Angioedema, Facial edema, Rash, Pruritus
|Renal and Urinary Disorders
|Nephrotic syndrome (following attempted immune tolerance induction)
|General Disorders and Administration Site Conditions
|Infusion site reactions, including Infusion site pain
In addition to reactions listed above, myocardial infarction has been identified in the published literature with other Factor IX products.
SRC: NLM .