The TGA has advised that it has learned that one batch of Duro-K 600mg potassium chloride tablets exceed permitted lead levels
Following testing to comply with the new regulatory guidelines that came into effect in December 2017, 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 says that it 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,” the TGA says.
As of 13 March 2018, there have been no reports of adverse events relating to exposure to lead associated with Duro-K, it says.
“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.”
Health professionals are asked to consider informing patients taking Duro-K 600mg potassium chloride tablets of the issue.
Patients are asked not to be alarmed, and that even if they are taking tablets from the one affected batch, the health risk is considered negligible.