Other safety alerts
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| Australia: Duro-K 600mg potassium chloride tablets: Advisory – lead content may exceed regulatory guidelines |
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The Therapeutic Goods Administration (TGA) advises consumers and health professionals that the TGA is aware that one batch of Duro-K 600mg potassium chloride tablets that has been supplied in Australia has higher levels of lead than permitted under new regulatory guidelines.
Following testing to comply with a new regulatory guidelines that came into effect in Dec 2017, the sponsor, Novartis, notified the TGA that Duro-K potassium chloride 600mg tablets and Slow-K potassium chloride 600mg tablets may exceed the new maximum oral permitted daily exposure (PDE) for lead, which is 5 micrograms. The TGA then tested samples from each of the batches of Duro-K and Slow-K tablets that were being supplied in Australia. Of these samples, only one batch of Duro-K exceeded the new PDE for lead. However, that batch was compliant with the limit set by the previous guidelines, which was in effect at the time of manufacture. Novartis has also confirmed they no longer hold supply of this batch. The TGA also tested two other potassium chloride products, Span-K and Chlorvescent, which are sponsored by a different company. The lead content in these two products was within acceptable limits.
The TGA has determined that the lead content in the affected batch of Duro-K does not present a significant health risk, even for people taking the maximum dose (12 tablets per day). The PDE for lead in the new regulatory guidelines is based on the paediatric population, who absorb more lead than adults and are more sensitive to the toxic effects of lead. Duro-K tablets are not indicated for use in children. As of 13 Mar 2018, there have been no reports of adverse events relating to exposure to lead associated with Duro-K.
It should be noted that lead is a known impurity that can occur due to the mining process for potassium chloride.
Based on these considerations, the TGA has determined that no further action regarding the affected batch is required. However, any future batches of Duro-K and Slow-K tablets must be tested to ensure they comply with the new PDE for lead before they can be supplied in Australia.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/duro-k-600-mg-potassium-chloride-tablets
In Hong Kong, Novartis Pharmaceuticals (HK) Limited (Novartis) is currently the registration certificate holder of two pharmaceutical products under the name of Slow K, i.e. Slow K Tab 600mg (HK-00200) and Slow-K Tablets 600mg (HK-62640). In Dec 2017, Novartis notified the Department of Health (DH) that Slow K may exceed the new ICH (International Conference for Harmonisation) guidelines for elemental impurities, i.e. when taking a high dose of Slow K, the lead intake as a result of administering the product will exceed the new guidelines.
According to Novartis, the raw materials of Slow K naturally contain lead impurities, and lead intake will not exceed the above guidelines when general therapeutic dosage (i.e. two to three tablets per day) is used. As Slow K is registered and sold in various ICH member countries, Novartis notified the drug regulatory authorities of various countries and decided to suspend the global sales of the product.
The DH has continuously reviewed the requirements of the ICH, and other relevant international standards and pharmacopoeias to assess the safety and quality of drugs.
In response to Novartis' notification, the DH has contacted other drug suppliers to ensure local supply of the drug so that treatment of patients will not be affected. So far, the DH has not received any case of adverse drug reaction related to potassium chloride. The DH will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/Thursday, Mar 15, 2018
Issued at HKT 16:00
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