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FDA Issues Warning About So-Called Brain Supplement Prevagen

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.”

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.

“Prevagen” is hyped as a “brain vitamin” that can dramatically improve such things as learning, short-term memory and word recall. It is sold through major retailers, including CVS Pharmacy and Walgreens.  The company’s website says Prevagen does not carry any serious side-effects.

The ingredient in Prevagen is apoaequorin, which is found in a certain kind of jellyfish. But because the company manufactures a synthetic form of apoaequorin, the supplement is a drug, the FDA says. As a drug, the company must perform studies to show it is both effective and safe, and the company must follow drug labeling and marketing regulations.

This is another example of the blurry line between supplements and drugs and how consumers can get caught in the middle. The supplements industry makes a fortune through exaggerated or false promises. Clearly, the safety of Prevagen needs to be proven before it is offered to the public and should be sold as a drug, not a vitamin.

 

 
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Rob Jenner

Robert Jenner brings to the My Advocates medical and legal team more than 26 years experience representing injured consumers nation-wide against the manufacturers of dangerous prescription drugs, defective medical devices, tainted blood products, and other unsafe products. Mr. Jenner has been honored by his peers for inclusion in “The Best Lawyers in America” and “Maryland’s Super Lawyers”(named in Top 50). READ FULL BIO

6 Responses to “FDA Issues Warning About So-Called Brain Supplement Prevagen”

  1. avatar Frankie Rene White says:

    Just want to say thank you for exposing dangers in products which would normally be undisclosed to the public.

  2. avatar Cheryl says:

    Times have changed, you’re living in the past because today’s FDA has not only lost its credibility but has been clearly delineated time and time again as being dangerous to human health. Aspartame and flouride are just two examples of what the FDA supports.

    It’s as clear as day FDA is nothing more than a type of mafia operating on behalf of corporate interests. So when you attack a product, we don’t at all take what the FDA claims seriously. The agency has completely 100% lost all credibility. Because the FDA is attacking Prevegen, I’m going to use the product.

  3. avatar Urban Daniel says:

    Cheryl needs to read some of the non-FDA reports on Prevagen written in some cases by those with an education in that type of product. It has limited published positive results and most imply that it is somewhat like a placebo.

  4. avatar Ann says:

    Have to agree with Cheryl. FDA doesnt have much credibility lately. Every other commercial is a lawsuit against a drug that was FDA approved and now people are sick or dying from it. Consumers must be smart and do their research. Im sure they want Prevagin to be a drug so the big drug companies can manufacturer it and triple if not more, the price.

  5. My wife’s memory became so bad that we could not find her glasses in the house . . . later we found them in the freezer . . . she would cry because she was losing her memory . . . she has been taking Prevagen for a year and a half and her memory is back to normal . . . she is a retired university professor of biology and is very intelligent . . . we can only say Thanks God for Prevagen . . . Clancy DelForge Ed.D . . .

  6. avatar sarah says:

    I agree the FDA is bought by the big companies. There are side effects to anything you take so just do the research on this as any other thing you ingest.

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