No undeclared ingredients here, just dangerous levels of Vitamins A & D in an effectively unregulated dietary supplement called Soladek Vitamin Solution.
ISSUE: Tested samples of Soladek contained levels of vitamin A and vitamin D that were many times the recommended daily allowances for these vitamins. . .Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects. 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.
For vitamins, like many biochemically active compounds, more is not better. Rather, the body wants the right amount. Many vitamins are water soluble and very difficult to overdose on, as you simply eliminate the excess in your urine. Vitamins A & D are fat soluble and not so easily removed.
Usually, these cases have not been associated with reports of health problems. Not so in this case.
The FDA 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.
Normally, when we learn that alternative medicine substances are contaminated with actual, scientifically tested pharmaceuticals that happen to do the exact same thing the “all-natural” supplement purports to do (oops), we can happily report these issues are not associated with serious injury or death. Normally. Sometimes people do get hurt:
FDA has received multiple reports of adverse events associated with the use of Fruta Planta, including several cardiac events and one death. FDA laboratory analysis confirmed that Fruta Planta contains sibutramine, a controlled substance that was withdrawn from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Fruta Planta may also interact in life threatening ways with other medications a consumer may be taking.
– FDA Medwatch – “Fruta Planta: Public Notification – Undeclared Drug Ingredient” – 23 December 2010 (emphasis mine) Continue reading “When Supplements Work? or (may) Kill”
The Universe is a funny place, full of bizarre coincidences. Like, for example, did you know that every single “dietary supplement” with an undeclared drug ingredient that we have covered in our When Supplements “Work”. . . feature so far has contained, among all the drugs in the world, a regulated drug that treats exactly the same condition that the supplement claims to treat? What are the odds?
This week we get a double whammy from EZVille, Ltd. EZVille, Ltd. has issued a recall of Revivexxx (one guess what that is supposed to “revive”) and Solo Slim. Revivexxx is a male sexual enhancement supplement (DSHEA code for treating erectile dysfunction), which was found to contain the erectile dysfunction pharmaceutical tadalafil (marketed using a series of creepy commericals under the brand name Cialis). Tadalafil is known to have potentially dangerous interactions with medications containing nitrates, such as those taken for heart disease. Solo Slim is a weight loss supplement, which was found to contain the appetite suppressant didesmethyl sibutramine. Sibutramine can increase blood pressure and heart rate putting individuals at risk for stroke and other cardiovascular issues at greater risk.
Individuals for whom tadalafil and sibutramine are not viable therapeutic options due to interacting medications or underlying medical issues may be more likely to seek out these alternative products to avoid side effects. The undeclared presence of these drugs in these supplements exposes these “at risk” individuals to these potentially dangerous side effects without their knowledge, unarguably a worse situation than if they had knowingly been prescribed these medications under the observation of a trained health care professional. Continue reading “When Supplements “Work”. . .EZVille, Ltd – Where Health & Safety are Important-ish”