Study: Supplements Need More Scrutiny in U.S.

Poison centers have no information on most of them

FRIDAY, Jan. 10, 2003 (HealthDayNews) -- 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, appearing in tomorrow's 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 U.S. 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's 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 didn't 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's 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."

More information

For more on dietary supplements, visit the National Institutes of Health's Office of Dietary Supplements. For the industry's take, try the Council for Responsible Nutrition.

Related Stories

No stories found.
logo
www.healthday.com