Linezolid-Associated Neuropathy in Patients with MDR/XDR Tuberculosis in Shenzhen, China

Zhang, Peize; Li, Wei; Liu, Miaona; Zhan, Senlin; Zhang, Hailin; Deng, Guofang; Chen, Xiaoyou

doi:10.2147/idr.s365371

Cited by 11 publications

(3 citation statements)

References 23 publications

(43 reference statements)

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“…In MDR-TB patients with serum concentration > 2 mg/L, peripheral and optic neuropathy were more frequent than that of < 2 mg/L. [42] Compared to the study by Huerga et al DR-TB patients who received linezolid for individual regimens, the incidence of myelosuppression, peripheral neuropathy, and optic neuritis was 6.0%, 26.4%, and 3.1%, respectively. [21] Furthermore, Gao et al reported adverse events related to linezolid in MDR and XDR-TB were peripheral neuropathy (4.5%), thrombocytopenia (4.5%), neutropenia (4.0%), and optic neuritis (1.1%).…”

Section: Discussionmentioning

confidence: 71%

Six Months of Bedaquiline-Pretomanid-Linezolid (BPaL) Regimen in Patients with Drug-Resistant Tuberculosis: A Narrative Review

Putra

Faizah

2023

JETROMI

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Background: Drug-resistant tuberculosis (DR-TB) is more difficult to treat with multiple therapies and a longer duration than drug-sensitive tuberculosis. Pre-XDR and XDR-TB are highly DR-TB with a lower success treatment than MDR-TB. Therapy for high DR-TB with fewer drugs and shorter treatment is required to increase the success of treatment. We comprehensively reviewed the risk factors for unfavorable outcomes (death, treatment failure, and loss of follow-up) related to all oral regimens containing bedaquiline and or delamanid in patients with MDR-TB. Method: This was a narrative review to summarize the role of the BPaL regimen to manage highly DR-TB patients. Results: The six months of BPaL regimen was reported to provide treatment success in two previous trials, Nix and Zenix TB. BPaL offers treatment success, especially in highly DR-TB compared to standard regimens containing bedaquiline. However, several adverse effects, such as myelosuppression, peripheral neuropathy, and optic neuritis were more common in BPaL regimens than in standard regimens. In addition, the incidence of QTc interval prolongation was lower in BPaL regimens compared with standard regimens. It is mandatory to monitor adverse effects associated with linezolid in the BPaL regimen and how to manage them. Conclusion: This review concludes that the BPaL regimen provides treatment success over six months of treatment. Health facilities should prepare for the implementation of BPaL to manage DR-TB patients.

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Section: Discussionmentioning

confidence: 71%

Six Months of Bedaquiline-Pretomanid-Linezolid (BPaL) Regimen in Patients with Drug-Resistant Tuberculosis: A Narrative Review

Putra

Faizah

2023

JETROMI

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“… 19–21 Neuropathy is mainly described in patients treated for TB where the duration of treatment is much longer than 12 weeks and in combination with other antituberculosis medication. 11 , 22 , 23 In our cohort, with a median treatment duration of 42 days, the incidence of nervous system toxicity was low, probably due to the relatively shorter treatment duration up to 12 weeks for bone and joint infections compared with TB treatment.…”

Section: Discussionmentioning

confidence: 72%

Prolonged use of linezolid in bone and joint infections: a retrospective analysis of adverse effects

Veerman,

Goosen,

Spijkers

et al. 2023

Journal of Antimicrobial Chemotherapy

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Objectives Antibiotic treatment for bone and joint infections generally lasts for 6 weeks or longer. Linezolid may be a good option for treating bone and joint infections, but there is an increased risk of potential serious adverse drug events (ADEs) when used for more than 28 days. The aim of this study was to obtain detailed information on the type and time to occurrence of the patient-reported ADEs, the dynamics of haematopoiesis over time, and the reasons for early discontinuation of linezolid when used for an intended maximum duration of 12 weeks. Methods This single-centre retrospective study was conducted at the Sint Maartenskliniek in The Netherlands. Patients were included if they were planned to use linezolid for more than 28 days. The main reason for discontinuation of linezolid, the ADE according to the Naranjo score, and the time to occurrence of ADEs were analysed. Results Among 78 patients, drug toxicity led to early discontinuation of linezolid in 11 (14%) patients before and nine (12%) after 28 days of therapy. The median treatment duration was 42 days. Gastrointestinal intolerance (42%) and malaise (32%) were the most common ADEs. In 75% of the cases the ADE occurred within 28 days of therapy. Sixty-seven patients were able to continue linezolid beyond 28 days, 87% of whom completed therapy as scheduled. Severe cytopenia, according to the Common Terminology Criteria for Adverse events (CTCA), was observed in four patients and was reversible after discontinuation of linezolid. One patient suffered optic neuropathy related to linezolid use. Conclusions Linezolid could be considered an alternative option to the current standard of IV glycopeptides for the treatment of bone and joint infection for up to 12 weeks. If patients pass the first 28 days of therapy, the likelihood of successful completion of therapy is high with a low risk of serious ADEs.

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“…More recently, Zhang et al 41 reported episodes of neuropathy in 40% of the patients with MDR/extensively drug-resistant tuberculosis treated with linezolid. Of these patients, 69% had peripheral neuritis, 24% had optic neuritis, and 7% had both.…”

Section: Linezolid Underexposure: Missing From the Pimentioning

confidence: 99%

Why Product Information Should not be Set in Stone: Lessons from a Decade of Linezolid Therapeutic Drug Monitoring: An Opinion Paper

Marriott

Cattaneo

2023

Therapeutic Drug Monitoring

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WHAT IS 'PRODUCT INFORMATION'?The "product information" (PI) for a medicine contains the documents providing officially approved information for health care professionals and patients. The regulatory agencies for drugs (eg, the European Medicines Agency, the Food and Drug Administration, Therapeutic Goods of Australia) provide guidance and templates to give marketing authorization applicants practical advice on how to develop the PI for human medicines. A summary of the product characteristics, labelling, and package leaflets is included.The information in a PI document is written by the pharmaceutical company responsible for the medicine and approved by regulatory agencies. It provides objective information regarding the quality, safety, and effectiveness of the medicine, as demonstrated in the data provided by the pharmaceutical company. This information is intended to assist physicians, pharmacists, and other health care professionals in prescribing and dispensing medicines. In addition, health professionals in their consultations with patients can use this information so that patients are better informed about their medicines.A list of information that should be contained in the PI is highlighted in the box below. CAN A PHARMACEUTICAL COMPANY ALTER THE PI AFTER A MEDICINE IS MARKETED?As discussed above, the information in a PI document is written by the pharmaceutical company responsible for the medicine, based on the results of phase I-III registration trials. However, it is widely recognized that pharmacological and clinical data (efficacy/safety) may change when a drug is administered in real-world clinical practice. This is in large part because most complex patients, such as the elderly, patients with comorbidities receiving polypharmacy, patients with impairment of the excretory organs, or those undergoing renal replacement therapy are usually excluded from phase I-III clinical trials. In real life, these patients generally have access to the medicine in question, generating novel pharmacokinetic/pharmacodynamic (PK/PD) data when appropriate research is undertaken with the potential to reverse the key concepts provided in the PI. In addition, regulatory agencies require phase I studies aimed at characterizing the pharmacokinetics and safety of a new drug, which is conducted in healthy volunteers and typically after a single-dose administration. This is poorly representative of real-life scenarios in clinical practice and is an additional limitation to the applicability of the PI to all patients receiving a drug.In general, researchers who are independent of the pharmaceutical company that marketed the drug generate most of the data pertaining to a drug in real-life settings. It is presently unclear who should undertake periodic revisions of the PI, taking into consideration new evidence reported in the literature. If new data are generated during patent coverage, the pharmaceutical company responsible for the marketing of the medicine is expected to submit amended versions of the PI to regulatory agenci...

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Linezolid-Associated Neuropathy in Patients with MDR/XDR Tuberculosis in Shenzhen, China

Cited by 11 publications

References 23 publications

Six Months of Bedaquiline-Pretomanid-Linezolid (BPaL) Regimen in Patients with Drug-Resistant Tuberculosis: A Narrative Review

Six Months of Bedaquiline-Pretomanid-Linezolid (BPaL) Regimen in Patients with Drug-Resistant Tuberculosis: A Narrative Review

Prolonged use of linezolid in bone and joint infections: a retrospective analysis of adverse effects

Why Product Information Should not be Set in Stone: Lessons from a Decade of Linezolid Therapeutic Drug Monitoring: An Opinion Paper

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