FDA Approves Vyvanse for Binge Eating Disorder

Last month, after little outside input, the Food and Drug Administration swiftly approved Vyvanse — originally marketed as an attention deficit hyperactivity disorder drug — to treat Binge Eating Disorder (BED), calling it “an effective option to help curb episodes of binge-eating.”

Days after Vyvense was approved, retired professional tennis player Monica Seles coincidentally began appearing on popular television talk shows and was featured in People magazine sharing her struggle with binge eating. The timing wasn’t coincidental; Seles is a paid spokesperson for Shire, the makers of Vyvanse, and the face of the BED drug’s marketing campaign. Along with Seles, Shire also launched a website to spur social media and began providing funding for patient groups.

Health care experts have raised concerns at the aggressive tactics Dublin based Shire is using to market Vyvanse. Originally developed to treat ADHD, the drug is a type of amphetamine that is classified by the federal government as having a high potential for abuse.

In an excellent New York Times article (Shire, Maker of Binge-Eating Drug Vyvanse, First Marketed the Disease, Feb. 24, 2015) Katie Thomas writes about Shires marketing strategy and how pharmaceutical companies “seek to influence the diagnosis and treatment of a medical condition — in an effort to make billions of dollars in sales — even in the face of concerns about potential dangers of a drug.”

Even before it was approved to treat BED, Shire had been examining ways to recycle Vyvanse to be used in other arenas. Speaking at the Reuters Health Summit in 2011, the company’s CEO expressed hope that the company would expand Vyvanse to treat schizophrenia, depression and binge eating, and generate “multiple billions of dollars” in sales.

This highlights a disturbing trend in the pharmaceutical industry where drug companies, in social media-speak, have been trolling diseases to create new markets for drugs. New drugs are being rushed to market in as little as six months so industry can start making money while their safety is still being determined. Companies pressure the FDA for this quick approval and sometimes it is years before the true side effects are discovered. Pharmaceutical companies, like Shire, also pressure the FDA to allow them repurpose drugs for different diseases then they were originally intended, often without adequate testing.

Vyvanse has already proven to be problematic. In approving the drug, the FDA listed several major side effects. The information wasn’t new, but the agency warned that Vyvanse could cause strokes or heart attack, psychotic symptoms or even sudden death for those with heart problems. From 2004 – 2012 the most common side effects reported to the FDA were insomnia, drug ineffective, decreased appetite, and aggression. Most serious has been the suggested link between Vyvanse and suicides in children. Since the drug was approved to treat ADHD in 2007 over 130 reports about suicide and Vyvanse were given to the FDA.

Shire has also previously come under legal fire regarding its promotion of Vyvanse. In 2011 the FDA cited the company for misleading advertising and in 2014 Shire paid $56 million to settle federal charges that it improperly marketed the drug. Despite denying the charges, Shire was accused of marketing Vyvanse for unapproved, off-label uses and falsely representing how safe the drug was – including downplaying Vyvanse’s addiction potential.

Even with this problematic track record, Shire convinced the FDA to allow them to recycle Vyvanse, and now expects to make hundreds of millions more marketing what are essentially amphetamines for treatment of a condition that wasn’t even classified until 2013. Expect to see Monica Seles on your television soon – so far she has refused to disclose how much she was paid to promote the drug.