WASHINGTON -- The FDA has issued a warning against use of the vitamin solution Soladek because of dangerously high levels of vitamins A and D.
The product -- marketed by the Dominican company Indo Pharma -- contains vitamin A and D levels many times greater than the recommended dosage and may cause decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea according to adverse events reports, an FDA statement said.
Soladek is marketed as a treatment for "hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy," the statement said.
It is sold in a box containing a single vial of the solution that is labeled in Spanish.
Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, hypertension, heart arrhythmia, kidney damage, mental health changes, and coma.
Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects.
Patients who have used the solution and have experienced any of these symptoms should consult a healthcare professional immediately, the statement said. Consumers with vials of Soladek should stop using it immediately.
The FDA has received a number of adverse event reports related to the product, which has not been submitted to the agency for review or approval and may be being marketed illegally in the U.S.