Ayurvedic medicines containing lead, other heavy metals and scheduled poisons

What is the issue?

The Department of Health continues to receive notifications of cases of lead poisoning caused by the ingestion of imported Ayurvedic medicines that are contaminated with lead. Testing of these medicines has shown contamination with other heavy metals such as mercury and arsenic.

The Department of Health has also been informed that a range of Ayurvedic medicines for sale in some grocery stores in Victoria contain:

• ingredients that are scheduled poisons, some of which are prohibited for supply and use in Australia because of the danger they pose to human health. Examples include Azadirachta indica (which may be identified as “neem” or “Veppilai”) and Acorus calamus (which may be identified as “Ghodbach”, “Vacha”, “Vasambu”, or “Vat Jata”)
• ingredients that may indicate the presence of heavy metals.

Who is at risk?

Anyone taking Ayurvedic medicines imported from overseas or purchased in Australia where the product does not have an ‘AUST R’ or ‘AUST L’ number on the packaging may be at risk. Some groups, such as children or pregnant women, may be at higher risk.

Symptoms and transmission

The health effects from exposure to lead depend on a number of factors including:

• a person’s age
• how much lead they are exposed to and for how long
• if they have any other health conditions.

Acute lead poisoning is very serious and is usually caused by a recent exposure to a high amount of lead. The symptoms may include:

• abdominal pain
• constipation
• fatigue
• headache
• nausea and vomiting
• seizures.

Extremely high blood lead levels can cause long-term organ damage and even death.

A person who is exposed to smaller amounts of lead over a longer period may have symptoms such as:

• irritability
• fatigue
• loss of appetite
• difficulties with memory and concentration
• behavioural problems
• raised blood pressure
• poor coordination.

The symptoms of low-level exposure can be hard to detect clinically but can still cause long-term harm. Many of the symptoms above could be caused by other conditions.

Symptoms from other poisons that may be in Ayurvedic medicines that have no AUST L or AUST R number include:

• nausea and vomiting
• diarrhoea
• numbness and muscle weakness
• seizures
• respiratory (breathing) and cardiovascular (heart) problems
• miscarriage if used in pregnancy.

How are Ayurvedic medicines regulated in Australia?

Medicines, including Ayurvedic medicines, are regulated by the Therapeutic Goods Administration (TGA). Ayurvedic medicines supplied in Australia must be included in a central database maintained by the TGA, known as the Australian Register of Therapeutic Goods. You can identify if the TGA has listed a medicine on the Australian Register of Therapeutic Goods by checking to see if it has an AUST R or AUST L number on the package. For further information on how the TGA regulates registered and listed medicines, see the TGA's website.

The benefits of purchasing complementary medicines that are regulated by the TGA include that these products are low risk when taken as directed, contain the ingredients identified on the label and were made in accordance with strict manufacturing practices.

Where a product does not have an AUST number, it may be unregulated, and so does not come with any assurances. Anyone buying unregulated medicines, either from a local retailer or online, may be wasting their money and risking their health.

If side effects from taking a product are suspected to have occurred (also known as an adverse event), please report it to the TGA.

• Consumers are advised to seek medical advice and can report the adverse event or problem online through the TGA’s website Report an adverse event or problem (consumers) | Therapeutic Goods Administration (TGA) or by calling 1300 MEDICINE (1300 633 424).
• Health professionals can report an adverse event to the TGA Report an adverse event or problem (health professionals) | Therapeutic Goods Administration (TGA) and can report problems requiring urgent investigation by calling the TGA’s Pharmacovigilance and Special Access Branch on 1800 020 653.

Recommendations

For the general public

• Anyone taking Ayurvedic medicines imported from overseas or purchased in Victoria where the product does not have an ‘AUST L’ or ‘AUST R’ label should stop taking the product immediately.
• Anyone planning to purchase or use complementary medicines should look for the ‘AUST L’ or ‘AUST R’ number on the packaging to know that these medicines have been approved by the TGA for supply and use in Australia.
  • There is no guarantee that complementary medicines purchased online, overseas or available in grocery stores that are not on the Australian Register of Therapeutic Goods (ARTG) have been manufactured to Australian standards of safety and quality. These medicines may be contaminated with chemicals, contain illegal ingredients or have the wrong amount of active ingredient. This can lead to serious health consequences.
  • Some online retailers may sell non-ARTG listed, out-of-date, low-quality, fake or even harmful medicines.
• If anyone does want to purchase online, it’s important they carefully consider the risks involved and make sure the product is genuine and safe. Some websites may have fake Australian addresses and business identifiers (ABN or ACN). All business identifiers can be searched in either the Australian Business Register (ABR) or with the Australian Securities and Investment Commission (ASIC).

For health professionals

• Clinicians should consider testing for elevated blood lead for anyone taking unapproved Ayurvedic medicines.