So, What Could Go Wrong with Unregulated Dietary Supplements?

As noted before on this blog (see below), dietary supplements, marketed as health aids, can be quite dangerous.  More data on the complications has been published (AI Geller et. NEJM 2015; 373:1531-1540).

Here is an excerpt of a summary from the NY Times: Dietary Supplements Lead to 20,000 E.R. Visits Yearly, Study Finds

A large new study by the federal government found that injuries caused by dietary supplements lead to more than 20,000 emergency room visits a year, many involving young adults with cardiovascular problems after taking supplements marketed for weight loss and energy enhancement.

The study is the first to document the extent of severe injuries and hospitalizations tied to dietary supplements, a rapidly growing $32 billion a year industry that has attracted increased scrutiny in the past year and prompted calls for tougher regulation of herbal products….

Among the injuries cited were severe allergic reactions, heart trouble, nausea and vomiting, which were tied to a broad variety of supplements including herbal pills, amino acids, vitamins and minerals. Roughly 10 percent, or about 2,150 cases yearly, were serious enough to require hospitalization, the researchers found…

More than a quarter of the emergency room visits occurred among people ages 20 to 34, and half of these cases were caused by a supplement that was marketed for weight loss or energy enhancement…

Medical experts say that these products can be particularly hazardous because they have potent effects on the body and are frequently adulterated with toxic chemicals. The new study found that cardiovascular problems were even more commonly associated with weight loss and energy supplements than prescription stimulants like amphetamine and Adderall, which by law must carry warnings about their potential to cause cardiac side effects…

Under a 1994 federal law that has been widely criticized by health authorities, supplements are considered safe until proved otherwise.

Other points from the study:

  • “Child-resistant packaging is not required for dietary supplements other than those containing iron”
  • While these supplements result in <5% of the numbers for hospitalizations and admissions for pharmaceutical products, “dietary supplements are not regulated and marketed under the presumption of safety.”

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Web is Better: Liver Toxicity from Herbs

A recent review article (Clin Gastroenterol Hepatol 2014; 1069-76) provides a good overview of herbs and liver injury; however, the NIH website http://livertox.nih.gov/ is more comprehensive.

The article notes the difficulty in assessing liver injury from herbs and dietary supplements due to the permissive regulatory environment and underreporting.

Specific products reviewed include the following:

  • Weight loss supplements: hydroxycut, herbalife, green tea, usnic acid
  • “Health-promoting” herbs: black cohosh, comfrey, kava
  • Joint health supplements: flavocoxid, glucosamine
  • Bodybuilding supplements: anabolic steroids

The article explains issues with regard to causality and the regulatory issues. However, for each of these products, I found them on the livertox website. So, that is where I would start if I needed to look up herb-induced liver injury.  Reporting of adverse events can occur through FDA website: http://www.fda.gov/safety/medwatch/default.htm or through hotline: 800-FDS-1088.

A related reference –Bad Way to Lose Weight: “SlimQuickTM-Associated Hepatotoxicity Resulting in Fulminant Liver Failure and Orthotopic Liver Transplantation” ACG Case Rep J 2014;1(4):220–222. http://dx.doi.org/10.14309/crj.2014.59. Published: July 8, 2014

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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.

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