Ayurvedic Dietary Supplements by Shree Baidyanath: Consumer Advice Notice - Products Contain High Levels of Lead and/or Mercury

AUDIENCE: Consumers

ISSUE: Consumers who have used any of the Baidyanath brand Ayurvedic dietary supplements listed in theConsumer Advice Notice should stop using them and consult their health care provider. Testing by the New York Department of Health and the U.S. Food and Drug Administration (FDA) has found that these products contain high levels of lead and/or mercury, which can cause serious health problems. Excessive exposure to mercury can cause kidney or gastrointestinal problems with short-term use, while exposure over a month or longer could lead to neurological problems and potentially be fatal. High levels can also affect the development of the nervous system of a pregnant woman’s unborn child. Some signs of mercury poisoning may include loss of coordination, vision or hearing, "pins and needles" sensations usually in the hands, feet, and around the mouth, or muscle weakness.

BACKGROUND: The products are manufactured by Shree Baidyanath Ayurved Bhawan in India and sold in the United States at retail and via the Internet. One major retailer has recalled the products. The FDA is working to identify other companies that may have sold the products.

RECOMMENDATION:

If you are taking any of these Baidyanath brand Ayurvedic products, stop taking them immediately and consult your health care provider. Even if you are not having symptoms and feel healthy, you could have high levels of lead or mercury in your body.
If you believe that you are having an adverse event related to these products, seek immediate medical care or advice from a poison control center.
Pregnant women and parents of children who may have taken any of these products should ask their health care provider whether medical testing may be warranted.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch Safety Alert, including a link to the Consumer Advice Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm463213.htm