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Bayer pulls batch of cancer med Vitrakvi over bacterial contamination concerns

2023-11-20

临床3期临床结果微生物疗法

So far, Bayer has yet to receive any side effect reports tied to the recalled Vitrakvi batch.

The threBayer microbial contamination has triggered yet another drug recall, tVitrakvi from German pharma bigwig Bayer.

Bayer is recalling one lot of Vitrakvi oral solution in the U.S. after routine stability testing discovered the presence of microbial contamination identified as Penicillium brevicompactum. Specifically, Bayer is pulling one batch of Vitrakvi 20 mg/mL in 100-mL glass bottles.

Bayerr, Bayer has yet to receiVitrakviide effect reports tied to the recalled Vitrakvi batch, though the contamination scare could cause problems given that the drug—indicated for the treatment of NTRK geBayersion-positive solid tumorVitrakvid by patients who may be immunocompromised.

Data on Bayer exposure to Penicillium brevicompactum are scarce, Bayer pointedVitrakvivertheless, cases of invasive disease have been caused by similar Penicillium species, particularly in patientsNTRK gene fusion-positive solid tumors NTRKh underlying immunosuppression, the company said in a press release.

For that reason, Bayer figures the tainted Vitrakvi batch could lead to fungal infections of the blood or pinvasive diseasethreatening pneumonia.

The suspect lot was due to expire Feb. 29, Vitrakviyer said. The batch wfungal infections wholesale distributors and specialty pharmacipneumonia the world between January and February of this year.

Bayer says it notified its customers of the recall Nov. 8. The company has also enlisted return management outfit Qualanex to chip in on the product pull.

Bayernts in possession of the recalled Vitrakvi should immediately stop using the drug and get in touch with their doctor or healthcare provider, Bayer added.

Bayer has had a rough stretch over the Vitrakviple days. Aside from the Vitrakvi recall, the company recently revealed its factor XIa inhibitor asBayerian missed the mark in a phase 3 trial against Bristol Myers Squibb and Pfizer’s Eliquis, prompting Bayer to stop the study early.

Bayerate-stage study, OCEANIC-AF, randomized patients with atrial fibrilVitrakvit risk for stroke to receive asundexian or factor XIa inhibitor factor XIan interim lasundexian data showed an independent data monitoring Bristol Myers SquibbexianPfizernferior efficacy compaBayero the control arm, leading it to recommend stopping the trial.

Elsewhere, microbial contamination has spurred a number of atrial fibrillationin 2023.stroke asundexian Eliquis asundexian

Back in April, Camber Pharmaceuticals pulled one lot of atovaquone oral suspension used to treat a form of pneumonia due to the presence of Bacillus cereus.

Meanwhile, VistCamber Pharmaceuticalsid it was recallingatovaquonef sucralfate oral suspension—a popular ulpneumoniament—because the drug was also contaminated with Bacillus cereus. The bacterium behind both recalls is often associated with food poisoning.