Clinical Trials 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 practice.

The data described below and in Table 1 reflect exposure in 25 subjects (age range 27-82 years; 17 women; 21 Caucasians) with vitamin B₁₂ deficiency (12 with pernicious anemia, 4 secondary to gastrointestinal surgery, 9 with unknown cause) who received CaloMist Nasal Spray 50 mcg daily for 8 weeks in an uncontrolled clinical trial. Prior to enrollment, all subjects were required to have normal vitamin B₁₂ levels with intramuscular vitamin BI2 injections. One patient who completed the study developed epistaxis on Day 12 of dosing and was noted to have irritation of the right nasal septum at study end. This patient had pre-existing allergic rhinitis and required a doubling of the CaloMist Nasal Spray dose during the last week of the study because of declining vitamin B₁₂ concentrations.

Table 1. Potentially related adverse reactions reported during 8 weeks of treatment with CaloMist Nasal Spray in an uncontrolled clinical trial.

Experience with Parenteral Vitamin B₁₂

The following adverse reactions have been reported with parenteral vitamin B₁₂:

Generalized: Anaphylactic shock and death

Cardiovascular: Pulmonary edema and congestive heart failure early in treatment Peripheral vascular thrombosis

Hematological : Polycythemia vera

Gastrointestinal: Mild transient diarrhea Dermatological: Itching; transitory exanthema

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of cyanocobalamin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Angioedema and angioedema-like reactions [See WARNINGS and PRECAUTIONS]

Most antibiotics, methotrexate, and pyrimethamine invalidate the vitamin B₁₂ diagnostic blood assays.

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