Terbinafine

## Report on Terbinafine Adverse Drug Reaction Labeling **1. Executive Summary:** This report analyzes a directive from the Central Drugs Standard Control Organization (CDSCO) regarding the drug Terbinafine. The directive mandates that manufacturers of Terbinafine formulations include Acute Generalized Exanthematous Pustulosis (AGEP) as an adverse drug reaction (ADR) in the drug's label, package insert, and promotional literature. This change is based on recommendations from the Pharmacovigilance Programme of India (PvPI) and the Subject Expert Committee (SEC). The key finding is that Terbinafine manufacturers must immediately update their product labeling to comply with this new requirement. **2. Introduction:** This report aims to provide a comprehensive overview of a directive issued by the CDSCO concerning the labeling of Terbinafine products. The analysis is based solely on the information provided in the directive text. **3. Policy Overview:** This directive constitutes an *amendment* to existing regulations concerning the labeling and marketing of Terbinafine. * **Core Objective(s):** Based on the text, the core objective is to enhance patient safety by ensuring that healthcare professionals and patients are aware of the potential adverse drug reaction, Acute Generalized Exanthematous Pustulosis (AGEP), associated with Terbinafine use. **4. Background and Rationale:** This is an amendment because it adds information to existing product labeling requirements. The likely reason for this specific amendment is the identification of a potential safety concern related to Terbinafine: the occurrence of Acute Generalized Exanthematous Pustulosis (AGEP) as an adverse drug reaction. The PvPI's review of ADR reports and the subsequent deliberation by the SEC indicate that there is sufficient evidence to warrant including AGEP in the drug's prescribing information. **5. Key Provisions / Changes:** This is an amendment, therefore the following items describe the changes: * **What specific part of the original policy is being changed:** The directive amends the existing labeling requirements for Terbinafine products. Specifically, it targets the "label/Package insert/Promotional Literature" of the drug. * **What the *new* rule/provision *is*, based *only* on the amendment text:** The new rule mandates that all manufacturers of Terbinafine formulations must include Acute Generalized Exanthematous Pustulosis (AGEP) as an adverse drug reaction in the label, package insert, and promotional literature of the drug. * **Explain the *difference* or the *effect* of this specific change:** This change ensures that patients and healthcare providers are informed of a previously unlisted, but potentially serious, adverse reaction associated with Terbinafine. This allows for more informed prescribing decisions and potentially earlier recognition and management of AGEP if it occurs. **6. Target Audience and Stakeholders:** The primary target audience and stakeholders are: * Manufacturers of Terbinafine formulations in India. * State/UT Drugs Controllers (who are tasked with directing the manufacturers). * Healthcare professionals prescribing and dispensing Terbinafine. * Patients using Terbinafine. **7. Implementation Aspects (Inferred):** * **Responsible agency/bodies mentioned:** * Central Drugs Standard Control Organization (CDSCO) is the issuing and overseeing body. * National Coordination Centre for Pharmacovigilance Programme of India (NCCPvPI) provided the initial recommendation. * Subject Expert Committee (SEC) deliberated on the recommendation. * State/UT Drugs Controllers are responsible for directing manufacturers. * **Any timelines or procedures specified *in the text*?:** The directive requests the State/UT Drugs Controllers to direct manufacturers immediately and to intimate the CDSCO of the action taken. This implies an expectation of prompt action, though no specific deadline is mentioned. **8. Expected Outcomes / Impact of Changes:** The likely intended outcome of this amendment is improved patient safety. By including AGEP as an ADR on Terbinafine labels, the amendment aims to: * Increase awareness of this potential adverse effect among healthcare professionals and patients. * Facilitate earlier diagnosis and management of AGEP in patients taking Terbinafine. * Potentially reduce the incidence of severe complications associated with AGEP through timely intervention. * Potentially impact prescribing habits by alerting physicians to this risk. **9. Conclusion:** The CDSCO directive mandates a critical update to the labeling of Terbinafine products, requiring the inclusion of Acute Generalized Exanthematous Pustulosis (AGEP) as an adverse drug reaction. This amendment reflects a commitment to patient safety and highlights the importance of ongoing pharmacovigilance. Terbinafine manufacturers must comply with this directive promptly to ensure that patients and healthcare providers have access to complete and accurate information about the drug's potential risks.

Key Entities Referenced