Natpara (parathyroid hormone) is currently the only available adjunctive treatment for adult patients with chronic hypoparathyroidism.
The product was approved by the US Food and Drug Administration (FDA) in 2015 and brought Takeda sales of $230m in 2018.
Effective immediately, the recall was issued by the company due to a potential hazard related to rubber particulates originating from the rubber septum of the product’s cartridge.
Each day during the 14-day treatment period, the septum is punctured by a needle to obtain the daily dosage of the solution. According to Takeda, when the septum is repeatedly punctured, small rubber fragments may detach into the cartridge.
The recall regards to injection doses of 25, 50, 75 and 100 mcg.
According to the drug developer, discontinuing Natpara abruptly can cause a sharp decrease in blood calcium levels, leading to serious health consequences.
In a related announcement, Takeda advised patients using Natpara to consult their healthcare providers to ensure safe discontinuation and stated that it is working to resume the product’s supply ‘as soon as possible’.