Medicine recalls
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| The United States: Takeda issues US recall of NATPARA (parathyroid hormone) for Injection due to the potential for rubber particulate |
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The US Food and Drug Administration (FDA) announces that Takeda Pharmaceutical Company Limited is issuing a US recall for all doses of NATPARA (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg). This recall is being conducted after discussions with the FDA and is effective immediately due to a potential issue related to rubber particulates originating from the rubber septum of the NATPARA cartridge. During the 14-day NATPARA treatment period, the septum is punctured by a needle each day to obtain the daily dosage of NATPARA solution. When the septum is repeatedly punctured, it is possible that small rubber fragments may detach into the cartridge.
Consistent with the product labeling, Takeda is alerting NATPARA patients and prescribers that discontinuing NATPARA abruptly can cause a sharp decrease in blood calcium levels (severe hypocalcemia) which can result in serious health consequences. It is critically important that patients contact their prescribing healthcare provider to discuss their individual treatment plan and ensure close supervision, including frequent monitoring of blood calcium levels and close titration of active vitamin D and calcium supplements upon stopping NATPARA to avoid low blood calcium (hypocalcemia).
Takeda is committed to supply integrity, and is working closely with FDA to resolve the issue and resume supply as soon as possible
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/takeda-issues-us-recall-natparar-parathyroid-hormone-injection-due-potential-rubber-particulate
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Sep 17, 2019
Issued at HKT 15:00
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