We are aware of an issue causing the title of some ARTG entries to disappear. We are investigating as a priority and hope to have this resolved as soon as possible.
The Therapeutic Goods Administration (TGA) received advice about high levels of lead and other heavy metals in the Ayervedic medicine named Penisole. Penisole is labelled to contain the ingredient Trivang Bhasma (also known as Trivanga Bhasma) which is a combination containing Naga (lead), Vanga (tin) and Yashada (zinc).
The Victorian State Government published a Chief Health Officer Advisory alerting consumers to the detection of high levels of lead present in Penisole. Taking Penisole could result in lead poisoning, a serious condition that can cause long-term health effects, 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.
Ayurvedic medicines are a type of complementary medicine (sometimes known as 'traditional medicine') originating from India. Penisole capsules have not been approved for supply in Australia. However, the TGA is aware that Penisole capsules are available for sale on international websites.
TGA has published alerts about similar products in the past including on Manasmithra Vatika (Manasamitram Pills) Ayurvedic medicine.
Information for consumers
If you, or someone you care for, has Penisole capsules, 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 on the medicine label. 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 contain the ingredients identified on the label and were made under strict manufacturing standards. If you buy unregulated medicines, either from a local retailer or online, you may be wasting your money and risking your health.
Information for health professionals
Please be aware of the above issue and advise patients accordingly if they seek advice. If your patient has taken Penisole it is recommended to assess them for lead and heavy metal poisoning.
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.
If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.
The TGA encourages the reporting of suspected non-compliant advertising.
Contact for members of the media:
- Email: news@health.gov.au
- Phone: 02 6289 7400