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Manasmithra Vatika (Manasamitram Pills) Ayurvedic medicine

Safety advisory - contains dangerous levels of lead and other heavy metals

25 September 2020

The Therapeutic Goods Administration (TGA), in conjunction with state health authorities, is investigating a report of the presence of dangerous levels of lead and other heavy metals in the Ayurvedic medicine Manasmithra Vatika (Manasamitram Pills).

Ayurvedic medicines are a type of complementary medicine (sometimes known as 'traditional medicine') originating from India.

The TGA is aware that Manasmithra Vatika was supplied to practitioners and patients in NSW and Victoria, but there may have been further product distribution to other states.

If high levels of lead are present in these products, taking them could result in lead poisoning. Lead poisoning is a serious condition that can cause long-term health effects up to and including organ damage and death. Pregnant women and children are at a greater level of risk of lead poisoning.

Further information on symptoms can be found on the Victoria Health website alert. Information on the health risks of lead exposure is available at the Better Health website.

Information for consumers

If you, or someone you care for, has Manasmithra Vatika (Manasamitram Pills), do not use them. If you have already taken some of these pills, you should seek medical advice from your doctor or call the Poisons Information Centre on 13 11 26.

If you suspect you have had a side effect (also known as an adverse event) to this product, please report it to the TGA. In addition, if you have concerns about this or other products, you can make a report to the TGA on 1800 020 653 or through our website.

You can identify if a medicine has been included on the Australian Register of Therapeutic Goods (ARTG) by checking to see if it has an AUST R or AUST L number. For further information on how we regulate registered and listed medicines, see the TGA's website.

The benefits of purchasing complementary medicines that are regulated by the TGA include that you have assurances that those products are safe and contain the ingredients identified on the label.

If you buy unregulated medicines, either from a local retailer or online, you may be wasting your money and/or risking your health.

Information for health professionals

Please be aware of the above issue and advise patients accordingly if they seek advice.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Phone: 1800 020 653

Online: Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products