Most clinical evidence comes from dermatology and wound-healing studies with sample sizes under 100 participants
Reported reactions included nausea, vomiting, chills, low blood pressure, breathing difficulty and hospitalization, with excessive endotoxin exposure identified as a concern
Its usually ideal for delivering systemic effects
Cardiovascular (Heart and Blood Vessel) Complications In rare but serious cases, B12 replacement can lead to heart and blood vessel problems: Shortness of breath Peripheral edema (swelling in legs and arms) Rapid weight gain Pulmonary edema (fluid in lungs) Congestive heart failure (heart cannot pump effectively) Blood clots in vessels These complications arise from increased blood volume, thicker blood, and sudden changes in how hard the heart needs to work
However, if serum cobalamin concentration is within the normal range, treatment should be continued at least monthly (for parenteral supplementation) and the owner should be forewarned that clinical signs may recur sometime in the future
any change in regulation still requires FDA rulemaking for the individual compounds