FDA Issues Soladex Vitamin Solution Warning

The U.S. Food and Drug Administration (FDA) just issued a warning to consumers to stop using <"http://www.yourlawyer.com/practice_areas/defective_drugs">Soladek Vitamin Solution due to the risk of serious health problems from dangerously high levels of vitamins A and D. The defective Soladek is a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic.

Soladek is marketed with 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 product is sold in a box labeled in Spanish and containing a vial of the solution.

The FDA recently received information that tested samples of Soladek, which contained levels of vitamin A and vitamin D that were many times the recommended daily allowances for these vitamins. Intake of excessively high levels of these vitamins poses a risk to human health.

The FDA also received seven reports of serious health problems occurring in consumers using the product. The problems include decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea.

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 are in possession of Soladek should stop using the product immediately. Any consumers who have been using Soladek and are experiencing any of these symptoms should see a doctor immediately.

Soladek cannot be marketed legally in the United States because U.S. law prohibits the sale of products claiming to treat disease conditions without review and approval by the FDA; however, the reports of adverse events and other information leads the FDA to conclude that Soladek may be available illegally in the country; therefore, the agency is issuing this warning.

Health care professionals and consumers should report adverse events or other problems with regulated products to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax, or phone: Online at https://www.accessdata.fda.gov/scripts/medwatch; by Regular Mail by using FDA postage paid form 3500 and mailing it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787; by fax at: 800-FDA-0178; or by telephone at: 800-FDA-1088. 

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