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.
|Preferred Term||CaloMist Nasal Spray (cyanocobalamin)
|Nasal Discomfort||2 (8%)|
|Back Pain||1 (4%)|
|Influenza Like Illness||1 (4%)|
|Pharyngolaryngeal Pain||1 (4%)|
|Postnasal Drip||1 (4%)|
|Procedural Pain||1 (4%)|
|Sinus Headache||1 (4%)|
|Tooth Abscess||1 (4%)|
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
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]