Study: Supplements Need More Scrutiny in USPoison centers have no information on most dietary supplements< January 14, 2003 > People are suffering heart attacks, seizures, liver failure, and even death after taking various dietary supplements, says a new study that calls for more regulation of the substances and for a better system of monitoring harmful reactions. Dietary supplements—in the form of botanicals, herbal remedies, minerals, vitamins, and "cultural remedies" such as Asian herbal prescription medicines—are unregulated. According to the study, which appeared in a recent issue of The Lancet, some 29,000 such products are currently sold in the United States. These products do not have to be tested before hitting the stores and the US Food and Drug Administration (FDA) only monitors problems post-marketing. What's more, monitoring is done only on a voluntary basis, says an FDA official who spoke on the condition of anonymity. If a problem is reported, it is up to the FDA to prove there really is a problem. Manufacturers of pharmaceutical drugs, by contrast, are required to report all potential side effects to the FDA before a drug is sold to consumers. The article also notes there is no comprehensive and accessible register of supplement names and ingredients, further hindering any efforts to monitor health effects. A spokesman for the supplement industry says the study is flawed because the reports are "spontaneous" and the researchers did not know whether people misused the products. Issues of interactions, dosages, concentrations, and ingredients are often not spelled out with dietary supplements, says Dr. Lewis Kohl, chairman of emergency medicine at Long Island College Hospital in Brooklyn. "Those are the scarier things," he says. On the other hand, some of these substances may actually help people—it is just a question of which ones and at what dose. "Some dietary supplements do have a benefit and if they would get them studied they may be very nice, very inexpensive alternatives to modern medicine," Kohl says. The study authors enlisted the help of 11 poison control centers throughout the United States to assess what kinds of bad effects people were experiencing. They also sought information on the toll of long-term use and multiple ingredients, and gauged how complete the information sources were. Over the course of almost a year, the 11 centers recorded details of 2,332 telephone calls regarding 1,466 ingestions of dietary supplements. Patients had symptoms in 784 of these cases. The researchers then selected 489 cases in which the negative events seemed to be associated with the dietary supplements. Less than 36 percent of 1,232 dietary supplement products reported to the poison control centers were listed in the commercial information database routinely used by the centers' staffs. Less than half of adverse effects were recorded in five additional sources. One-third of the events recorded were "linked to hazardous results," the authors state, among them heart attacks, coma, bleeding, seizures, and four deaths. People using more than one ingredient tended to have worse symptoms, as did people who were older or who had been using the supplements over longer periods of time. Certain populations also seemed to be at an increased risk for bad effects, including users of aphrodisiacs such as yohimbine, women seeking herbal abortions and other alternative obstetric care, dieters, and bodybuilders. At least 28 percent of the callers reported that they were using the supplements to treat a disease, indicating that consumers find the regulatory distinction between prescription medicines and dietary supplements confusing. Safety issues should be paramount, the study authors conclude, specifically, questions of child-resistant packaging, exposure during pregnancy, multiple ingredients, long-term use, and surveillance efforts. A surveillance system such as the one already in place for drugs would be "ideal," says Susan Smolinske, a co-author of the study and managing director of the Children's Hospital of Michigan Regional Poison Control Center in Detroit. With such a system, the manufacturer is responsible for reporting every side effect. "It doesn't work that way with dietary supplements," she says. Right now, poison control centers have to rely on a database which, this study found, may or may not have information on a particular ingredient or brand name of a dietary supplement. "If you tell me you [ingested] XYZ supplement, I would type it in," Smolinske says. "If it was there I could capture the data, but if it's not I can't capture it. Until that database gets all the products listed in it it's going to be difficult to do the best job in surveillance." With such a database in place, if an unusual incident occurred, it would be much easier to issue an alert and, if necessary, pull the product from the market. John Hathcock, vice president of nutritional and regulatory science for the Council for Responsible Nutrition, a trade group, says the study finds no smoking gun between supplement use and sickness. "Poison-control centers do a good job of accumulating every possible contention, report, even remote possibility of an adverse effect, but these are spontaneous reports coming from all sources," he says. "What is not generally separated out well enough is whether these reports have any real substance with regard to are there adverse effects. That, in a nutshell, is a great weakness of the study." No seller of supplements wants to hurt anybody, Hathcock says, and "the record shows that for vast majority of dietary supplement products appropriately used, there's not a problem." Always consult your physician for more information.
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For more information on dietary supplements, please visit the Complementary & Alternative Medicine information module on this Web site. In Other News About Your Health:Feds Lax in Policing Gene-Altered Foods, Group SaysThe US Food and Drug Administration (FDA) has not sufficiently regulated companies that produce genetically altered foods, according to the Washington, D.C.-based Center for Science in the Public Interest (CSPI). The consumer group says the lack of strong government safeguards means harmful compounds could show up in some foods without consumers' knowledge. Although the current food supply seems safe, the group says, the FDA's regulations are chock full of loopholes that need immediate plugging. Current regulations are mostly a patchwork of voluntary recommendations and of older laws that were never written to deal specifically with genetically altered foods, the group says. An FDA spokesperson calls the risk to the nation's food supply "very hypothetical," but states that the agency is studying whether changes to its food-oversight policies are needed. And a food industry spokesperson, while calling the current set of voluntary regulations adequate, says the industry could support some type of mandatory FDA review. Always consult your physician for more information. New Labeling Required for Hormone Therapy ProductsFemale hormone replacement products, including those that contain estrogen and/or progestin, will be required to contain a new "black box" warning highlighting a user's increased risk of breast cancer and cardiovascular disease, the US Food and Drug Administration (FDA) has recently announced. The FDA says an estimated 10 million postmenopausal women in the United States use estrogen and combination estrogen with progestin products for relief of "hot flashes," night sweats, and other menopause symptoms. Such medications are marketed under brand names including Prempro, Premphase, and Premarin. The FDA says it ordered the labeling changes after reviewing data from the government's recent Women's Health Initiative (WHI) study, which was abruptly halted last July after researchers found a significantly increased risk of breast cancer and heart disease among study participants. FDA Commissioner Scott McClellan says women using or considering hormone replacement therapy should discuss with their physicians how the new warnings may affect them. Always consult your physician for more information. |
