More than half of American adults take vitamins, minerals, herbs, or other nutritional supplements. Some of those products aren’t especially helpful, readers told us in a recent survey, but that aside, don’t assume they’re safe because they’re “all natural.” They may be neither. Here are 10 hazards that we’ve distilled from interviews with experts, published research, and our own analysis of reports of serious adverse events submitted to the Food and Drug Administration, which we obtained through a Freedom of Information Act request. Read and be warned.
More than 6,300 reports of serious adverse events associated with dietary supplements, including vitamins and herbs, streamed into the FDA from supplement companies, consumers, health-care providers, and others between 2007 and mid-April of 2012. The reports by themselves don’t prove the supplements caused the problems, but the raw numbers are cause for some concern. Symptoms included signs of heart, kidney, or liver problems, aches, allergic reactions, fatigue, nausea, pains, and vomiting.
The reports described more than 10,300 serious outcomes (some included more than one), including 115 deaths and more than 2,100 hospitalizations, 1,000 serious injuries or illnesses, 900 emergency-room visits, and some 4,000 other important medical events.
The FDA gets far more reports about serious problems with prescription medication than about supplements. But there’s a big difference between the two, notes Pieter Cohen, M.D., an internist at Cambridge Health Alliance in Massachusetts with a special interest in supplements. “These powerful medications with powerful side effects are actually saving lives when used appropriately,” he says of prescription drugs. “But when healthy consumers use supplements, there’s rarely, if ever, a powerful lifesaving effect.”
The FDA suspects most supplement problems never come to its attention, says Daniel Fabricant, Ph.D., director of the agency’s Division of Dietary Supplement Programs. But those that do are still useful because they can raise red flags about a developing problem. For instance, last year the agency noted seven reports of serious health problems regarding consumers who took Soladek vitamin solution, marketed by Indo Pharma of the Dominican Republic. When the FDA learned that tested samples contained vitamins A and D at concentrations many times the recommended daily allowances, it issued a consumer warning.
Why not simply order a problem product off the market? Current laws make that so difficult for the FDA that to date it has banned only one ingredient, ephedrine alkaloids. That effort dragged on for a decade, during which ephedra weight-loss products were implicated in thousands of adverse events, including deaths.
Type the name of the supplement you’re interested in into the search box at www.fda.gov to see whether it has been subject to warnings, alerts, or voluntary recalls. If you suspect you’re having a bad reaction to a supplement, tell your doctor. You can also report your problem to the FDA at 800-332-1088 or www.fda.gov/medwatch.
Fabricant has said that dietary supplements spiked with prescription drugs are “the largest threat” to consumer safety. Since 2008 there have been recalls of more than 400 such products, mostly those marketed for bodybuilding, sexual enhancement, and weight loss, according to the FDA.
We’ve seen many recalled products that have contained the same or similar active ingredients as prescription drugs, such as sildenafil (Viagra), tadalafil (Cialis), and sibutramine (Meridia, a weight-loss drug that was withdrawn from the market in 2010 because of evidence that it increased the risk of heart attacks and strokes). Others contained synthetic steroids.
Those adulterated products can cause some of the same side effects and interactions that consumers may have been trying to avoid by choosing supplements over drugs. The FDA has received reports of strokes, acute liver injury, kidney failure, pulmonary embolism (blood clots in the lung), and death associated with drug-tainted supplements.
“A number of the spiked sexual enhancement products claim to work within 20 to 45 minutes,” Fabricant said on the FDA’s website. “When we see a product that makes claims above and beyond what a dietary supplement might do—above supporting health—and within a time frame of a few minutes, it tips us off that we might have a spiked product.”
Slim down with diet and exercise. Build muscles by weight training. And consult a doctor if you need help in the bedroom, since it could indicate an underlying health problem. If you suspect you’ve purchased a product that is tainted with undeclared prescription drugs or steroids, send an e-mail about it to the FDA, at firstname.lastname@example.org.