Buyer Beware: Supplement at Your Own Risk

Although I’m a pretty good swimmer, I am always a little uneasy when I see signs that say “Swim at Your Own Risk.” Perhaps, signs like that should accompany ‘dietary supplements’ since they are unregulated and often pose a significant unknown danger.

A fascinating perspective article discusses the myriad of problems with over-the-counter supplements (NEJM 2014; 370: 1277-80).  The article begins by detailing the cases of severe hepatitis and death due to OxyElite Pro, a supplement marketed for weight loss and muscle building.  This agent was linked to 97 patients, 47 required hospitalizations, 3 resulted in liver transplantation (that’s one way to lose weight!), and one death.  An astute liver-transplant surgeon was the first to suspect this supplement.

Since then “nothing has been done to prevent another supplement from causing organ failure or death.”

Key points:

  • Supplement industry: $32 billion spent in U.S. per year on 85,000 different combinations of vitamins, minerals, botanicals, amino acids, probiotics, and other ingredients
  • Supplements do not require premarketing approval.  “Under the Dietary Supplement Health and Education Act of 1994, anything labeled as a dietary supplement is assumed to be safe until proven otherwise.”
  • More than 500 supplements have already been found to be adulterated with pharmaceuticals like anabolic steroids, unapproved antidepressants, banned weight-loss medications, untested sildenafil analogues, and even methamphetamine analogues.
  • The FDAs ability to monitor these supplements is poor.  The MedWatch (https://www.safetyreporting.hhs.gov) is plagued with underreporting and lack of timeliness.  Local health departments have frequently stumbled upon the problem first.

Some common problems with current supplements include the following:

  1. Arrhythmias with agents like Ephedra, horny goat weed, and oleander
  2. Bleeding with Ginkgo
  3. Cancer with anabolic steroids (hepatoma), Beta-carotene (lung cancer), and Vitamin E (prostate cancer)
  4. Hepatotoxicity with numerous supplements including chaparral, comfrey, fo-ti, gerrymander, and kava
  5. Other problems: stroke, kidney stones, panic attacks, rashes, and mood alterations

The perspective notes that a bill in a Senate committee if passed would require that manufacturers register their products and provide some safety information.  This is unlikely to make any significant change.  The author recommends that “every supplement ingredient should undergo rigorous safety testing before marketing.”

Bottomline: when a patient asks you if “this supplement” is OK, the honest answer is nobody knows.

Related blog post:

4 thoughts on “Buyer Beware: Supplement at Your Own Risk

  1. Pingback: Upside Down Incentives in Pharmaceutical Development –Profit over Patients | gutsandgrowth

  2. Pingback: “Supplements and Safety” | gutsandgrowth

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