Last Updated on December 31, 2023 by The Health Master
Drug recall
In a recent development, Bayer has taken the precautionary step of voluntarily Drug recall of one lot of its cancer drug Vitrakvi in the United States.
This article delves into the details of this recall, shedding light on the reasons behind this decision and its potential implications for patients.
Reason for drug Recall
During routine stability testing, Bayer identified the presence of microbial contamination in the drug. This alarming discovery prompted the company to take swift action to ensure patient safety.
Adverse Event Reports
As of now, Bayer has not received any adverse event reports related to the recalled lot.
This information is crucial in understanding the current impact on patients who may have used Vitrakvi from the affected batch.
Drug Description
Vitrakvi, the subject of this recall, is a drug approved for use in patients with advanced solid tumor cancers possessing a rare gene mutation.
Understanding the drug’s intended use provides context to the potential risks associated with its contamination.
Contaminant Identification
The source of the contamination has been identified as Penicillium brevicompactum, a slow-growing fungus.
This section provides insights into the nature of the contaminant, helping readers grasp the severity of the situation.
Health Risks
The ingestion of Penicillium brevicompactum poses a “reasonable probability” of invasive fungal infections or life-threatening pneumonia, especially for patients who are already immunocompromised.
This part of the article outlines the potential health risks faced by those using Vitrakvi from the affected lot.
Recalled Lot Details
The impacted lot consists of 192 100ml glass bottles of the oral solution form of Vitrakvi.
Understanding the scale of the recall helps in assessing its reach and impact on patients and healthcare providers.
Patient Accessibility
Bayer assures patients that despite the recall, there will be no disruption in accessing Vitrakvi.
This reassurance is essential for individuals relying on the drug for their treatment.
Distribution Information
The recall affects products distributed to wholesalers and specialty pharmacies between January 3 and February 13 of this year.
Bayer promptly informed these distributors of the recall on November 8, 2023.
Expiration Date
The impacted lot carries an expiration date of February 29, 2024. This information is vital for patients and healthcare providers to identify the affected products.
Must read: CDSCO Guidelines on Drug Recall
Customer Instructions
Customers possessing the recalled lot are advised to cease its use immediately and contact their physician or healthcare provider.
Clear instructions are crucial in ensuring the safety and well-being of those who may have the affected drug.
Recall Impact
This section discusses the broader impact of the recall on patients and healthcare providers.
It also highlights the steps taken by Bayer to mitigate the potential risks associated with the contaminated drug.
USFDA Involvement
Importantly, the recall is being conducted with the knowledge and cooperation of the U.S. Food and Drug Administration (USFDA.
This collaboration ensures a comprehensive and regulated approach to managing the situation.
FAQs
- Q: How was the contamination discovered?
- A: The presence of microbial contamination was identified during routine stability testing.
- Q: Are there any reported adverse events related to the recalled lot?
- A: As of now, Bayer has not received any adverse event reports associated with the affected lot.
- Q: What is the risk associated with the identified contaminant?
- A: Ingestion of Penicillium brevicompactum may lead to invasive fungal infections or life-threatening pneumonia, especially in immunocompromised patients.
- Q: How many bottles are there in the recalled lot?
- A: The impacted lot comprises 192 100ml glass bottles of the oral solution form of Vitrakvi.
- Q: What should customers with the recalled lot do?
- A: Customers are advised to immediately stop using the drug and contact their physician or healthcare provider.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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