Medicine recalls
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| The United States: Bayer issues voluntary nationwide recall of Vitrakvi® (larotrectinib) Oral Solution 20mg/ml due to presence of microbial contamination |
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The US Food and Drug Administration (FDA) announces that Bayer is voluntarily recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20mg/ml (lot number: 2114228) in 100ml glass bottles to the consumer/user level. The product is being recalled due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing.
Given that Vitrakvi® is indicated for the treatment of solid tumors that are NTRK gene fusion positive, it is expected that patients on Vitrakvi® may be immunocompromised. Although there is little data in the literature on human pathology caused by Penicillium brevicompactum, there are cases of invasive disease caused by similar Penicillium species, particularly in patients with underlying immunosuppression. Therefore, there is a reasonable probability that ingestion of Penicillium brevicompactum in patients on Vitrakvi® with underlying immunosuppression may result in invasive fungal infections of the blood or pneumonia that can be life-threatening. To date, Bayer has not received any adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-issues-voluntary-recall-nationwide-vitrakvir-larotrectinib-oral-solution-20-mgml-due-presence
In Hong Kong, Vitrakvi Oral Solution 20mg/ml (HK-66493) is a pharmaceutical product registered by Bayer Healthcare Limited (Bayer). The product is a prescription-only medicine. As confirmed with Bayer, the affected lot has not been imported into Hong Kong. Related news was previously issued by Health Canada, and was posted on the Drug Office website on 9 Nov 2023.
Ends/Wednesday, Nov 22, 2023
Issued at HKT 14:30
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