Stop using Soladek vitamin solution, FDA warns

Consumer Reports News: March 29, 2011 08:58 AM

The Food and Drug Administration this week warned consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic, because the product might contain dangerously high levels of vitamins A and D.

The FDA said it received seven reports of serious health problems in people using the product. They include decreased kidney function, elevated levels of calcium in the blood, fatigue, abnormal heart rate or rhythm, vomiting, and diarrhea.

The FDA advised Soladek users to seek medical care immediately if experiencing those symptoms or symptoms of vitamin A toxicity (which include anemia, anorexia, hair loss, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects) or vitamin D toxicity (which include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma.)

The FDA said Soladek can't be legally marketed in the U.S. because federal law prohibits the sale of products claiming to treat disease conditions without FDA review and approval.

Meanwhile, doctors reported in the February 2011 issue of the Journal of Clinical Endocrinology & Metabolism that nine patients at Columbia University Medical Center who had too much calcium in the blood had reported taking Soladek, which the article said was "readily available" in Upper Manhattan.

FDA Warns Consumers to Stop Using Soladek Vitamin Solution [Food and Drug Administration]

Vitamin D Toxicity Due to a Commonly Available "Over the Counter" Remedy from the Dominican Republic [The Journal of Clinical Endocrinology & Metabolism]

—Doug Podolsky