Core Viewpoint - The "Black Box Warning" is the highest level of risk alert in the global pharmaceutical regulatory system, aimed at clearly communicating potential severe risks associated with medications to healthcare professionals and patients [1][3]. Group 1: Definition and Purpose - The Black Box Warning was introduced by the FDA and has been adopted by many other countries' regulatory agencies, initially targeting drugs with serious safety concerns identified post-market [1]. - The warning has expanded to include drugs that may pose significant risks during the new drug approval process if severe potential risks are identified [1]. Group 2: Regulatory Conditions - Regulatory agencies implement Black Box Warning when: 1. A drug has clear adverse reactions that can lead to severe consequences [3]. 2. Improper use (e.g., dosage, duration, special populations) significantly increases risks [3]. 3. Drug interactions with other medications or foods may result in fatal outcomes [3]. Group 3: Usage Guidelines - Patients must fully understand the content of the Black Box Warning and the associated severe adverse reactions before using such medications [6]. - Medications with Black Box Warnings should be used under strict medical guidance, adhering to prescribed dosages and schedules [6]. - Patients should monitor their health closely for any abnormal symptoms and seek immediate medical attention if severe reactions occur [6]. Group 4: Antituberculosis Drug Challenges - Antituberculosis treatment faces challenges such as numerous adverse reactions and lengthy treatment durations, complicating patient compliance [7]. - The development of new antituberculosis drugs has been slow, with only three new drugs approved in nearly 50 years [7]. - Bedaquiline, the first new antituberculosis drug in 50 years, has a Black Box Warning due to increased mortality risk and potential QT prolongation [7][9]. Group 5: Recent Drug Approvals - Delamanid, approved in 2014, also carries a Black Box Warning for QT interval prolongation, necessitating regular ECG checks during treatment [9]. - Pretomanid, approved in 2019, does not have a Black Box Warning, indicating a relatively better safety profile and showing promise in treating drug-resistant tuberculosis [11]. Group 6: Risk Management - Black Box Warning does not equate to prohibition; drugs like Bedaquiline and Delamanid remain crucial for tuberculosis control [14]. - Physicians will weigh the benefits and risks based on individual patient conditions to create tailored treatment plans [14]. - The WHO-recommended BPaL/M regimen has gained international recognition for its safety and efficacy, contributing to the goal of ending tuberculosis by 2035 [14].