Dangers of Dieter's Teas : Adverse Effects

by Food and Drug Administration (FDA)

(Page 2 of 2)

Reports filed with FDA indicate that users tend to experience adverse effects when they misuse the products by, for example, steeping the tea longer than product labeling recommends or drinking more than the recommended amount. The reports indicate three types of adverse events:

Short-term: stomach cramps, nausea, vomiting, and diarrhea lasting several days. These symptoms are likely to occur in first-time users who drink more than the recommended amount.

Chronic: chronic diarrhea, pain and constipation due to laxative dependency, which causes a sluggish bowel. In one report to FDA, a person who reported using herbal products with stimulant laxatives for decades suffered severe pain and constipation from loss of colon function and required surgery to remove the colon. People who develop chronic problems usually have used these types of products for years.

Severe: fainting, dehydration and electrolyte disorders (for example, low blood potassium, a condition that can cause paralysis, irregular heartbeat, and possibly death). People who develop severe problems tend to be those who are nutritionally compromised, partly as a result of drastic reductions in food intake — for example, rigorous weight-loss dieters and people with the eating disorders anorexia nervosa and bulimia. Four deaths reported to FDA involved women with a history of such medical problems. According to information presented at a 1995 meeting of FDA's Food Advisory Committee, these herbal stimulant laxatives may have been a contributing factor in their deaths.

Label Warning

At the 1995 meeting, the advisory committee's task group agreed that dietary supplements containing stimulant laxatives can have adverse effects and that a label statement would be helpful in warning consumers about the risks and reducing the incidence of these adverse effects. The group proposed this label warning:

"NOTICE (or WARNING): Contains herbs (insert name of herbs) that can act as stimulant laxatives. Prolonged steeping time can increase the risk of adverse laxative effects, including: nausea, vomiting, abdominal cramps, and diarrhea. Chronic use of laxatives can impair colon function. Use of laxatives may be hazardous in the presence of abdominal pain, nausea, vomiting, or rectal bleeding. Laxative-induced diarrhea does not significantly reduce absorption of food calories. Acute or chronic diarrhea may result in serious injury or death."

The full advisory committee concurred with the recommendations.

California has taken steps to require a similar warning label statement on all food products containing stimulant laxatives sold in that state. Some manufacturers have begun to carry the state's drafted warning statement on their food products. FDA will monitor products sold nationally to be sure that their labels carry information similar to that required in California.

Consumer Action

The California warning advises all users of these types of dietary supplements to:

• Read and follow package directions carefully.
• Stop using the product if diarrhea, loose stools, or stomach pain develop.
• See a doctor if frequent diarrhea develops.
• See a doctor before using the product if the user is pregnant, nursing, taking medication, or has a medical condition.

Consumers should report adverse effects associated with use of laxative teas or supplements to FDA by calling FDA's MedWatch adverse event and product problem hotline at 1-800-FDA-1088. Additional information about the MedWatch program can be found at www.fda.gov/medwatch/report/consumer/consumer.htm on FDA's Website. They also may write to FDA at 5600 Fishers Lane, HFC-160, Rockville, MD 20857.

The report should include:

• name, address and telephone number of the person who became ill
• name and address of the doctor or hospital providing medical treatment
• description of the problem
• name of the product and store where it was bought.

Consumers also should report the problem to the manufacturer or distributor listed on the product's label and to the store where the product was bought.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.