FDA Issues Warning on Imported Vitamin

WASHINGTONFDA issued a consumer warning regarding Soladek, a vitamin product marketed by Indo Pharma SA, based in the Dominican Republic, as the product may contain dangerously high levels of vitamins A and D. In its warning, FDA noted Soladek is marketed with Spanish language labeling featuring claims that the product treats 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 agency noted it received information that tested samples of Soladek contains levels of vitamin A and D that were may times the recommended daily allowances of these vitamins. Vitamin D toxicity can lead to fatigue, vomiting, changes in blood pressure and heart rate and kidney damage, while vitamin A toxicity can cause anemia, joint pain, liver abnormalities and birth defects. FDA added it has received seven reports of serious health problems occurring in people taking the product, including decreased renal function, elevated blood calcium levels, fatigue, arrhythmia, vomiting and diarrhea.

FDA stated Soladek cannot currently be marketed legally in the United States as its claims position the product as an unapproved and misbranded new drug; however, the agency has concluded it may be available illegally in the United States. The agency is therefore advising consumers to stop using the product immediately, and see a health care practitioner if they have any possible adverse reactions. Health care professionals and consumers can report adverse events to FDA online or by calling (800) FDA-1088.