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  5. FDA warns about heavy metal poisoning associated with certain unapproved ayurvedic drug products
  1. Information for Consumers and Patients | Drugs

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

Use of unapproved ayurvedic drug products containing harmful levels of heavy metals may cause heavy metal poisoning and a range of health problems such as high blood pressure, kidney injury, fatigue, gastrointestinal distress and neurologic symptoms. Product labels may or may not disclose the presence of heavy metals such as lead, mercury or arsenic. Ayurvedic products and their product labels are not approved by the agency, and FDA cannot ensure the safety of these products.

Consumers should consider the risks of taking these products and tell their doctor about all products they are taking, including ayurvedic products.

Ayurvedic medicine is a traditional system of healing arts that originated in India. FDA does not regulate the practice of ayurvedic medicine. 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.

No ayurvedic product is FDA-approved to prevent, treat, diagnose or cure any disease. Ayurvedic products marketed to prevent, treat, diagnose or cure any disease would be illegally marketed in the U.S.

What are the 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 (e.g., abdominal pain, constipation, diarrhea, nausea and vomiting), and
  • nervous system-related symptoms (e.g., 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).

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.

What should consumers or patients know and do?

  • Consider the risk of heavy metal poisoning if taking unapproved drug products labeled to contain heavy metals such as lead, arsenic and mercury.
  • Consider risk to your health if taking unapproved drugs labeled as ayurvedic that make claims to prevent, treat, diagnose or cure a disease. Some unapproved drug products can contain hidden ingredients harmful to your health.
  • If you have a health condition, talk with your health care provider before using ayurvedic products.
  • Tell your health care provider about all products you are taking, including 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.

What should health care providers do?

  • 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.
  • Caution patients about the risk of heavy metal poisoning from ayurvedic products.
  • Report products suspected of containing heavy metals to FDA’s MedWatch program.

What data did FDA find about this topic?

FDA searched multiple data sources, including the FDA Adverse Event Reporting System (FAERS) and the published medical literature, from January 1, 2008, through May 31, 2022. We identified cases in which use of ayurvedic products was associated with increased lead and arsenic levels in the blood or urine of patients ranging in age from newborn to 76 years. We found children’s blood lead levels that were 2-15 times higher than acceptable and adult blood lead levels that were 3-21 times higher than acceptable, based on thresholds for heavy metals published by the Centers for Disease Control and Prevention (CDC).

Lead content in various products ranged from 1.2 parts per million to 130,000 parts per million. For example, bottled water has less than 0.005 parts per million. Mercury, gold, thallium and other heavy metals were also detected. These findings are expected because the practice of ayurvedic medicine often intentionally incorporates various metals as product ingredients.

What is FDA doing?

FDA continues to evaluate reports about products of concern. FDA’s evaluation found that most unapproved ayurvedic drugs are not manufactured in the U.S. These products may be brought into the country by individuals, purchased online, or mailed internationally through personal shipments.

The agency continues to issue warning letters to manufacturers of these products and add companies to import alert to help stop these products from entering the U.S market. See FDA’s Unapproved Drug Import Alert 66-41 or Import Alert 99-42 food contaminated with heavy metals.

How can I get new safety information on these types of products?

Sign up for email alerts about safety concerns with drugs that have not been reviewed by FDA.

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