FDA Issues Warning About So-Called Brain Supplement Prevagen
on October 30, 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.”
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.
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