New Study on Supplement Safety: "Context Is Key"

A new study, reported on by USA Today and published in the New England Journal of Medicine, has found that each year around 23,000 emergency room (ER) visits can be attributed to adverse events from dietary supplements. This number was based on data from 63 emergency room departments from 2004 through 2013. However, data from the FDA paints a different picture: the FDA reports, for example, that there were only 3,249 adverse events associated with supplement use in 2012. Regardless, even if the 23,000 figure is accurate, the Council for Responsible Nutrition (a leading trade association representing dietary supplement manufacturers) emphasizes the need to view that number with caution, stating: “context is key to analyzing results of the new study.” Specifically:

  • Adding perspective to the numbers. If one considers that over 150 million Americans take dietary supplements, the new study’s findings actually suggest that supplement users have a relatively low risk of serious adverse events: 23,000 ER visits only represent about one-tenth of one percent of supplement users. In addition, according to the study’s lead author, the 23,000 ER visits reported for dietary supplements are less than 5% of those reported for pharmaceuticals. The severity of the adverse events is also an important consideration: 90% of the patients were discharged from the ER, suggesting that the adverse events either resolved on their own in the ER, or weren't serious enough to require further, immediate treatment in the hospital.
  • Questioning the data. There are indications that the number of adverse events for supplement users may be even lower than the study reports. The new study based its calculations in part on ER visits resulting from adverse events for ear and eye drops and other OTC products. But, under federal law, some of these OTC substances, such as topical remedies, are not considered supplements.
  • Understanding supplement regulations. Weight loss and energy supplements were implicated in around 25% and 10%, respectively, of the adverse events reported in the new study. Notably, some of the supplement manufacturers within these two categories have a history of not following the FDA’s Good Manufacturing Practices (GMPs). GMPs are a comprehensive set of regulations that manufacturers are required by law to follow (although not all manufacturers do). They outline guidelines for testing ingredients at key stages during the manufacturing process and ensuring that the finished product is tested for identity, purity, and strength. It’s also important to know that the FDA can recall a supplement if it poses a significant or serious risk to the safety of the consumer.
  • Practicing supplement safety. Some of the adverse events reported on in the new study were due to accidents: around 21% were due to misuse by unsupervised children and around 37% of adverse events in adults age 65 and older were due to pill-related choking. While the FDA does require that some supplements, such as iron, be packaged in child-proof containers, not all supplements are regulated in this way. Of course, as with any health-related practice, it’s important to take safety precautions. While the FDA does not regulate the size of supplement tablets or capsules, many manufacturers make gummy, liquid, or powder supplements to assist consumers who have difficulties swallowing tablets or capsules. Also, it is important to store supplements in a safe, high place, out of children’s reach; read and follow label instructions; discard supplements after the expiration date; and consult with your healthcare practitioner before adding any new supplements to your health regimen. Finally, it is important to do your homework, and to only purchase supplements from reputable manufacturers that follow GMPs.

Source: USA Today

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