Side effects from dietary supplements send 23,000 people a year to ER

Dietary supplements send at least 23,000 Americans a year to the emergency room and cause at least 2,000 to be hospitalized, according to a study published online Wednesday.

The true number of ER visits caused by dietary supplements – which include vitamins, minerals, herbs and other products – could be much larger than the study's estimates because many patients don't mention their supplement use when visiting the doctor, according to the study, published in The New England Journal of Medicine. 

The report has led some health advocates to renew calls for stronger regulation of supplements.

In the study, patients showed up at the ER with a range of symptoms, including chest pain and heart palpitations. Researchers based their estimates on reports from 63 hospitals from 2004 to 2013, using a surveillance system from the Centers for Disease Control and Prevention, the Food and Drug Administration and the Consumer Product Safety Commission. The surveillance system also has been used to study side effects from pharmaceuticals.

Many supplement users don't realize the products can cause serious side effects, said study coauthor Andrew Geller, a medical officer in CDC's division of health care quality promotion.

"Many Americans take dietary supplements in an effort to stay healthy, but these products can cause harm for some people," Geller said.

About 20% of supplement-related ER visits involved children who took the products while unsupervised, according to the study, which was co-written by researchers at the FDA.

With the exception of iron pills, supplements aren't required to be packaged in child-resistant containers. Yet, iron supplements – which can be fatal to children in large doses – were still the second-most common cause of an ER trip for children, in spite of the resistant packaging, Geller said.

Excluding these children's visits, about 25% of ER visits were related to weight-loss products, while 10% were related to energy supplements.

Among senior citizens, 38% went to the ER after a pill or pill fragment became lodged in the back of the throat, esophagus or windpipe, Geller said. He noted that the FDA doesn't limit the size of supplements, which can be too large for some people to swallow easily.

Unlike companies that make prescription or over-the-counter drugs, those that manufacture supplements aren't required to list possible side effects on their products, the study said.

That can leave some consumers unaware of the risk of taking too many, said emergency physician Jay Kaplan, president-elect of the American College of Emergency Physicians, who was not involved in the new study. Kaplan said he once treated a young man who overdosed on bodybuilding supplements and wound up in kidney failure.

Dietary supplements are used by 150 million Americans, according to the Council for Responsible Nutrition, which represents the $35 billion supplement industry. Douglas MacKay, senior vice president for scientific and regulatory affairs for the group, said the study overestimated the true number of supplement-related ER visits because researchers included some topical creams or homeopathic remedies, which aren't technically supplements.

Even if the researchers' estimate of 23,000 supplement-related ER visits is accurate, MacKay said, that would represent a fraction of 1% of all supplement users in the U.S., suggesting that the products are overwhelmingly safe.

"Supplements are used safely every day," said Daniel Fabricant, executive director and CEO of the Natural Products Association, a supplement industry group, and the former director of dietary supplement programs at the FDA.

Certain types of supplements,  especially those marketed for weight loss, bodybuilding and sexual enhancement, have a history of problems, said Josephine Briggs, director of the National Center for Complementary and Integrative Health at the National Institutes of Health. Some have been found to contain dangerous stimulants.

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Some supplements marketed as "all natural" have been found to contain pharmaceuticals. Certain "herbal Viagra" products, for example, have been found to contain the active ingredient in actual Viagra, Briggs said.

Earlier this year, tests from New York state found that only 21% of store-brand herbal supplements actually contained the plants advertised on their labels. The state attorney general asked retailers who made the supplements – GNC, Target, Walgreen's and Walmart – to stop selling them.

A spokesman for Consumers Union, the advocacy arm of  of Consumer Reports magazine, said the FDA should have more power to recall dangerous supplements. Supplements also should have to undergo safety testing before they're sold,  said Charles Bell, programs director for Consumers Union.

Unlike pharmaceutical makers, supplement manufacturers today don't have to prove that their products are safe before selling them, Bell said.

Consumers Union would "also like to see the FDA make greater use of hospital and poison control data to identify dangerous products and get them off the market more quickly," Bell said.

The FDA does have the power to force manufacturers to recall dangerous products. Fabricant said the FDA has all the authority it needs to ensure supplements are safe.

Both supplement makers and drug manufactures are already required to report serious side effects to the FDA and follow good manufacturing practices, Fabricant said.

The key difference between drugs and supplements, Fabricant said, is that supplements are regulated like a category of food, rather than medication. The FDA can take action against supplements if they cause harm or contain illegal ingredients.

Geller said consumers should take basic precautions with supplements.

For example, people with heart conditions should consult their doctors before beginning a weight-loss or energy supplement, Geller said. People with children in the home should store supplements "up, high and away" from kids.

Kaplan said supplement makers should be required to use child-resistant packaging.

"You can childproof your home, but that doesn't mean that children are not amazingly creative" about getting into trouble, Kaplan said. "If it costs these companies a little more money to do that, that's OK."

Fabricant said there's no need to make supplements child-resistant.

When children swallow supplements, "you're talking about a failure in parenting," not packaging, Fabricant said. "There's some personal responsibility here" on the part of parents who fail to supervise their children, he said.