Artemether + Lumefantrine

## Report on Artemether-Lumefantrine Adverse Drug Reaction (SJS) Labeling **1. Executive Summary:** This report analyzes a communication from the Central Drugs Standard Control Organization (CDSCO) regarding Artemether-Lumefantrine, an approved and marketed drug in India. The communication mandates that manufacturers include Steven Johnson Syndrome (SJS) as an adverse drug reaction in the drug's package insert and promotional literature. This directive stems from recommendations by the Pharmacovigilance Programme of India (PvPI) and the Subject Expert Committee (SEC) following the evaluation of adverse drug reaction (ADR) reports. The core purpose is to enhance patient safety by informing healthcare professionals and patients about this potential risk. **2. Introduction:** The purpose of this report is to provide an informative overview of the CDSCO communication (F. No. 120118DC Pt337) dated 19 JUN 2019 regarding the labeling of Artemether-Lumefantrine with respect to Steven Johnson Syndrome (SJS). The analysis is based solely on the provided text. **3. Policy Overview:** This communication can be considered an *amendment* to the existing regulatory framework governing drug labeling and marketing in India. * **Core Objective:** The core objective, inferred from the text, is to enhance patient safety by ensuring that prescribers and patients are informed about the potential adverse drug reaction (ADR) of Steven Johnson Syndrome (SJS) associated with Artemether-Lumefantrine. **4. Background and Rationale:** This amendment appears to be driven by the following: * ADR reports on Artemether-Lumefantrine, which were reviewed by the PvPI. * The PvPI's recommendation to incorporate SJS into the drug's prescribing information leaflet (PIL). * Deliberations by the SEC which further recommended the inclusion of SJS as an ADR. This suggests a need to update the existing labeling to reflect new safety information identified through pharmacovigilance activities. **5. Key Provisions / Changes:** This is an amendment, therefore we will focus on changes. * **What is being changed:** The amendment mandates a change to the package insert and promotional literature of Artemether-Lumefantrine formulations. * **What the *new* rule/provision *is*:** The new rule requires manufacturers of Artemether-Lumefantrine to include "Steven Johnson Syndrome (SJS)" as an adverse drug reaction in the package insert and promotional literature of the drug. * **Difference/Effect:** This amendment ensures that prescribers and patients are made aware of a potential, but potentially serious, adverse effect associated with the drug, enabling more informed decisions about its use. This information was previously absent (or not explicitly mentioned) in the labeling. **6. Target Audience and Stakeholders:** The primary target audience and stakeholders are: * Manufacturers of Artemether-Lumefantrine formulations. * State/UT Drugs Controllers who are responsible for overseeing the manufacturers within their jurisdiction. * Healthcare professionals prescribing Artemether-Lumefantrine. * Patients using Artemether-Lumefantrine. **7. Implementation Aspects (Inferred):** * **Responsible Agency/Bodies:** * CDSCO (Directorate General of Health Services) is the issuing authority. * State/UT Drugs Controllers are responsible for directing manufacturers to comply. * The National Coordination Centre for Pharmacovigilance Programme of India (NCCPvPI) at IPC Ghaziabad provides recommendations based on ADR reports. * **Timelines/Procedures:** The text requires State/UT Drugs Controllers to direct manufacturers to update the labeling and to report back to the CDSCO on the actions taken. However, a specific timeline for these actions is not explicitly stated in the provided text. * **Amendment Specific Implementation:** Manufacturers will need to update their packaging and promotional materials to include SJS as an ADR. State/UT drug controllers will need to monitor and enforce this change. **8. Expected Outcomes / Impact of Changes:** The intended outcome of this amendment is to: * Increase awareness of the risk of SJS associated with Artemether-Lumefantrine among healthcare professionals and patients. * Enable more informed prescribing and usage decisions. * Potentially reduce the incidence of SJS related to Artemether-Lumefantrine through heightened awareness and monitoring. * Improve patient safety. **9. Conclusion:** The CDSCO communication mandating the inclusion of Steven Johnson Syndrome (SJS) as an adverse drug reaction in the labeling of Artemether-Lumefantrine represents an important step towards enhancing patient safety. By informing healthcare professionals and patients about this potential risk, the amendment promotes more informed decision-making and potentially reduces the incidence of this serious ADR. The effectiveness of this amendment relies on the prompt and thorough implementation by manufacturers and the diligent oversight by State/UT Drugs Controllers.

Key Entities Referenced