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Wednesday, July 27, 2016

Prevagen under FDA Investigation

Class-Action Lawsuit Filed Against “Memory Supplement” Marketers

In January, 2015, a class-action suit was against Quincy Bioscience (QB) LLC the manufacturer of Prevagen. The company claims that the product works by re-supplying memory-related proteins that decline as people age. The lawsuit charges:

• The product cannot work as advertised because its only purported active ingredient, apoaequorin (a protein), is completely destroyed by the digestive system and transformed into common amino acids no different than those derived from other common food products.

• The amount of amino acids Prevagen adds to the user’s intake are trivial in comparison to normal dietary intake.

• Claims that clinical tests demonstrate that Prevagen will improve memory and support healthy brain function, sharper mind, and clearer thinking are false. (Note: QB’s “clinical trials” were conducted in-house and did not have independent verification.)

• Studies touted in Prevagen’s marketing campaign “if they exist at all, are, on their face, so seriously flawed that they demonstrate nothing regarding Prevagen.”

 FDA Announces Investigation of Prevagen (April 2012)

A supplement called Prevagen, which has helped propel its manufacturer, Quincy Bioscience, into the ranks of fastest-growing companies in the U.S., shows evidence of serious side-effects and should be marketed and regulated as a drug, says the U.S. Food and Drug Administration.

Anyone taking Prevagen should check with their doctor in light of the FDA’s disclosures about this so called “brain vitamin.”

Side Effects Reported, Then Ignored

In a warning letter, the FDA accused the company of not reporting to the government “adverse events like seizures, strokes, and worsening symptoms of multiple sclerosis that had been reported to your firm as being associated with the use of Prevagen products.” Reports about the supplement to the company have also included chest pain, tremors, fainting and other serious symptoms, the FDA says.

In fact, the company received more than 1,000 incidents and product complaints about Prevagen between May 2008 and December 1, 2011, and only investigated or reported two events, the letter says.

The FDA is waiting for the company’s response. It could seek legal action to halt the manufacture and marketing of Prevagen.

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