Soladek Side Effects Could Lead to Vitamin A and D Overdose: FDA

Federal drug safety regulators are warning consumers not to take Soladek, a vitamin supplement by Indo Pharma, S.A., because it could cause an overdose of vitamins A and D. 

The FDA issued the Soladek warning on March 28, after samples of the supplement were tested and found to contain many times the daily recommended allowances of vitamins A and D.

At least seven adverse event reports have been received by the FDA from people who took Soladek. Those reports have included serious health problems, including kidney problems, heart arrhythmia, vomiting and diarrhea, as well as elevated calcium in the blood.

FDA officials warn that taking Soladek could lead to vitamin A toxicity and vitamin D toxicity; also known as hypervitaminosis A and hypervitaminosis D. One consumer who took Soladek reportedly had 600,000 IU of vitamin D. The recommended daily allowance is 600 IU.

Vitamin A toxicity can cause anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver problems and birth defects. It can also cause softening of the skull bone, double vision and poor weight gain in infants and children. Vitamin D toxicity can cause weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, heart rhythm problems, kidney damage and coma, the FDA warns.

Soladek is sold primarily to Dominican Republic immigrants 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.” Soladek is sold in vials and labeled in Spanish.

The FDA said that Soladek is sold illegally in the U.S. because it is being marketed as a treatment to diseases and conditions without having been reviewed or approved by the FDA.

The agency is urging any consumers who have Soladek to stop using it immediately. If someone has taken Soladek and experienced any of the symptoms listed above, they should see a doctor immediately.