FDA warns about heavy metal poisoning associated with certain unapproved ayurvedic drug products

FDA warns consumers that using unapproved ayurvedic products containing harmful levels of heavy metals may cause heavy metal poisoning. Using these products may result in high blood pressure, kidney injury, fatigue, gastrointestinal distress and neurologic symptoms. There are no FDA-approved ayurvedic products. Ayurvedic products marketed to prevent, treat, diagnose or cure any disease are illegally marketed in the U.S.

Ayurvedic medicine is a traditional system of healing arts that originated in India. Ayurvedic products may include ingredients such as spices, herbs, vitamins, proteins and minerals, and some include heavy metals, such as lead, mercury, arsenic, iron and zinc. However, these products typically are not labeled to contain heavy metals such as lead, mercury or arsenic.

FDA’s recent product testing

An FDA laboratory recently tested Rheumacare Ayurvedic Proprietary Medicine purchased from NavaFresh.com. The testing found high levels of lead and mercury, as well as the presence of strychnine, brucine toxins and arsenic.

The agency urges consumers not to use Rheumacare. Consumers who have this product should discard it. The agency testing was based on an adverse event report of a consumer who used the product and experienced extremely elevated blood lead levels.

Symptoms of heavy metal poisoning or toxicity

Chronic exposure to heavy metals can lead to their accumulation in the body and cause harmful health effects like:

• high blood pressure
• kidney injury
• fatigue
• gastrointestinal symptoms such as abdominal pain, constipation, diarrhea, nausea and vomiting
• nervous system-related symptoms such as burning or tingling in the fingers and/or toes, weakness in limbs, dizziness or a spinning sensation, feeling agitated and not thinking clearly or being confused

Risks of heavy metal poisoning

• Adults and children can become very sick when heavy metals accumulate in their bodies over time, and large acute ingestions over short periods of time can be life-threatening.
• Chronic exposures to arsenic may increase the risk of cancer.
• If a mother has heavy metals in her body, the metals may enter her breast milk and be passed onto the baby during breastfeeding.

Information for consumers

• Talk with your health care provider before using ayurvedic products.
• Talk to your health care provider or consult with a poison center (1-800-222-1222) if you have used ayurvedic products and you are experiencing symptoms of possible heavy metal poisoning.
• Report products suspected of containing heavy metals to FDA’s MedWatch program.

Information for health care providers

• Ask patients about their use of all products, including ayurvedic products.
• Consider the potential for heavy metal toxicity among patients who indicate they use ayurvedic products if they exhibit signs or symptoms of heavy metal toxicity.
• Warn patients about the risks of heavy metal poisoning from ayurvedic products.
• Report products suspected of containing heavy metals to FDA’s MedWatch program.

Additional FDA actions to protect consumers

FDA works to protect consumers from potentially dangerous products by:

• Reviewing adverse event reports of heavy metal poisoning associated with ayurvedic products and tests certain products for heavy metals. When FDA identifies products with heavy metals, the agency recommends the company recall the product to protect consumers.
• Issuing warning letters to manufacturers of these products and adds companies to import alert to help stop these products from entering the U.S market (import alert 66-41 or import alert 99-42) to protect consumers.