NewsWhore
04-01-2011, 06:10 PM
The US Food and Drug Administration has issued a consumer warning against a very popular local over-the-counter pharmaceutical product, Soladek. Soladek is manufactured by Indo Pharma, an Indian company.
For years, Dominicans have taken the vitamin solution as an immune-system booster. The FDA now says there is the risk of serious health problems because it contains dangerously high levels of vitamins A and D.
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 FDA says it has 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.
Soladek cannot currently be marketed legally in the United States because US law prohibits the sale of products claiming to treat disease conditions without review and approval by the FDA. The FDA issued the warning because it has information that Soladek may be available illegally in the country.
Hoy reports that the National Commission for the Removal and Restriction of Pharmaceuticals would be meeting to determine what action needed to be taken. Meanwhile, J. Gasso Gasso, the distributors of the vitamin, also met with the Ministry.
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm248588.htm?sms_ss=facebook&at_xt=4d93a81af925308c%2C0 (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm248588.htm?sms_ss=facebook&at_xt=4d93a81af925308c%2C0)
More... (http://www.dr1.com/index.html#8)
For years, Dominicans have taken the vitamin solution as an immune-system booster. The FDA now says there is the risk of serious health problems because it contains dangerously high levels of vitamins A and D.
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 FDA says it has 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.
Soladek cannot currently be marketed legally in the United States because US law prohibits the sale of products claiming to treat disease conditions without review and approval by the FDA. The FDA issued the warning because it has information that Soladek may be available illegally in the country.
Hoy reports that the National Commission for the Removal and Restriction of Pharmaceuticals would be meeting to determine what action needed to be taken. Meanwhile, J. Gasso Gasso, the distributors of the vitamin, also met with the Ministry.
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm248588.htm?sms_ss=facebook&at_xt=4d93a81af925308c%2C0 (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm248588.htm?sms_ss=facebook&at_xt=4d93a81af925308c%2C0)
More... (http://www.dr1.com/index.html#8)