Soladek May Contain Toxic Levels of Vitamins A and D, FDA Warns
FDA warns consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, SA, of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D. In fact, tested samples of Soladek contained levels of vitamin A and vitamin D that were many times the recommended daily allowances for these vitamins. Further, FDA has received seven reports of serious health problems due to the use of Soladek including reports of decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea. While Soladek is an unapproved product and thus cannot be marketed legally in the US, reports of adverse events and other information leads FDA to conclude that Soladek may be available illegally.
FDA notes that symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma. Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects. Consumers who have obtained Soladek should stop using the product immediately. FDA also advises that anyone who has used the product and is experiencing any of the toxicity symptoms noted should see a physician immediately. More information is available in an FDA news release.