I’ve posted many times that consumers need to be cautious when buying and using supplements.
Supplements such as vitamins, minerals and herbal remedies are not regulated by the Food and Drug Administration (FDA); their usefulness and safety are debatable.
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So I was disturbed to read that two drugs that are sold only by prescription in other countries are available as dietary supplements in the US.
These drugs are vinpocetine and picamilon.
Vinpocetine is prescribed in Russia, China, Germany, and other countries for acute stroke and cognitive impairment, but it has never been approved by the FDA as a prescription drug.
Data on its neuroprotective effects are conflicting, while its known side effects include flushing, headaches, and decreased blood pressure.
It’s marketed in the US as “enhances memory” or “supports brain health.” It’s also sold as “natural” because it can be synthesized from vincamine, which is found in the leaves of the lesser periwinkle. But it is not natural.
Picamilon is also marketed for “cognitive support” as well as “stress reduction.”
Picamilion…was first developed by Russian investigators to increase CNS levels of GABA for treating anxiety and seizures. It’s currently used in Russia for various neurological conditions.
Both these drugs are readily available in different doses on Drugstore.com, Amazon and the large chain drugstores.
Researchers at Harvard Medical School analyzed different brands of both of these drugs and found
Only 26% of the vinpocetine brands provided consumers with accurate information about the dose of the ingredient in their product.
They found that 17 of the 23 vinpocetine brands contained quantities ranging from 0.3 mg to 32 mg per recommended daily serving—with many of these falling in the pharmaceutical dose range of the drug, which is 5 mg to 40 mg. There was no vinpocetine in six samples.
Of the 31 brands of picamilon supplements, 30 had quantities ranging from 2.7 mg to 721.5 mg per recommended daily serving. Prescription doses range from 50 mg to 200 mg.
These are pharmaceutical-grade drugs that should not be sold as supplements in the US, but unfortunately they are. Not only has their effectiveness not been proved, but the dosages can vary widely from what is on the label and that can be a poor value at best and dangerous at worst.
Save your money (and your health) and avoid these products.
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As one of the Harvard researchers said:
“The FDA has permitted an unapproved new drug with unproven efficacy and known adverse effects to be sold directly to consumers…The FDA should not permit unapproved drugs, even semisynthetic derivatives of natural compounds, to be sold as dietary supplements.”
“Remarkably,” he added, “the FDA has done nothing to intervene in the sale of these brain enhancing supplements containing unapproved drugs.”