FDA Warning on Soladek® Vitamin A and D Solution

Pam Flores @phflores Health Guide
  • Most of us are taking vitamin D and A plus other supplements, for bone loss, so we wanted to tell you about a warning issued by the FDA on a particular brand of these supplements. 

     

    The Food and Drug Administration (FDA) has issued a warning to stop taking Soladek® vitamin A and D solution.  They've also received reports of dangerous health problems from some consumers taking these supplements.

     

    The product is packaged in vial form and the vitamin information is printed in Spanish.

     

    The manufacturer also claims it cures a very long list of medical disorders, and you can't make that claim and sell it within the U.S. without it receiving the necessary testing and approval from the FDA.

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    "FDA recently received information that tested samples of Soladek 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 diarrhoea. Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhoea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma."

     

    "Symptoms of vitamin A toxicity include anaemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects." [1]

     

    Soladek Indo Pharma, SA, of the Dominican Republic is the manufacturer that has received this FDA warning.

     

    If you are taking this supplement, please note the FDA warning on this since the amounts in the product may have dangerously high levels of both vitamins.

     

    If you've purchased this product stop taking it and return the item to the retailer you purchased it from for a refund of monies spent. 

     

    If you are experiencing any of the symptoms above, contact your doctor immediately.  Also, the FDA advises that you file a report, if you've had these problems at their Adverse Events Reporting System.  By Regular Mail 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. 
You may also report this at the FDA MedWatch program.

     

    Full Food and Drug Administration warning on Soladek vitamin solution.

     

    At present this product can not be sold in the United States, however it is available through Internet sources which prompted this announcement.

     

    Sources:

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    1. Pharmabiz.com March 30, 2011http://www.pharmabiz.com/NewsDetails.aspx?aid=62132&sid=2

     

     

     

Published On: March 31, 2011