Global Briefs: Haleon, WHO & FDA 

A roundup of news from Haleon, The World Health Organization and the US Food and Drug Administration. Highlights below.  

* GSK Spin-out Company Haleon Recalling Select Lots of Robitussin Cough Syrup 
* WHO Issues AI Guidelines 
* FDA Requiring Boxed Warnings for Certain CAR T Therapies 

GSK Spin-out Company Haleon Recalling Select Lots of Robitussin Cough Syrup 
Haleon, the consumer healthcare spin-out company of GSK and now a stand-alone company, is voluntarily recalling eight lots of certain Robitussin cough-syrup products to the consumer level due to microbial contamination. The products being recalled are Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult.  

To date (as of January 24, 2024), Haleon says it has not received any reports of adverse events related to this recall. 

Source: US Food and Drug Administration 

WHO Issues AI Guidelines 
The World Health Organization (WHO) has issued new guidance on the ethics and governance of large multi-modal models (LMMs), a type of generative artificial intelligence (AI) technology with applications across healthcare. 

The guidance outlines over 40 recommendations for consideration by governments, technology companies, and healthcare providers for the appropriate use of LMMs. 

The new WHO guidance outlines five broad applications of LMMs for health: (1) diagnosis and clinical care, such as responding to patients’ written queries; (2) patient-guided use, such as for investigating symptoms and treatment; (3) clerical and administrative tasks, such as documenting and summarizing patient visits within electronic health records; (4) medical and nursing education, including providing trainees with simulated patient encounters; and (5) scientific research and drug development, including using it to identify new compounds. 

Source: The World Health Organization 

FDA Requiring Boxed Warnings for Certain CAR T Therapies 
The US Food and Drug Administration (FDA) has issued safety labeling change notification letters to all manufacturers of licensed B-cell maturation antigen (BCMA)-directed and CD19-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapies requiring a revision to the package insert due to the risk of T cell malignancies. 

The letters notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the medication guide for these products to identify the possibility of the increased risk of getting cancers, including certain types of cancers of the immune system. 

FDA announced last November (November 2023) that it was conducting an investigation and determined that the risk of T-cell malignancies was applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. These products were: (1) Gilead Sciences’ Kite Pharma’s Yescarta (axicabtagene ciloleucel); (2) Novartis’ Kymriah (tisagenlecleucel); (3) Johnson & Johnson’s and Legend Biotech’s Carvykti (ciltacabtagene autoleucel) (4) Bristol-Myers-Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel); (5) BMS’ Abecma (idecabtagene vicleucel); and (6) Gilead Sciences’ Kite Pharma’s Tecartus (brexucabtagene autoleucel).   

Source: The US Food and Drug Administration