In December 2023, the EMA's PRAC concluded a review of Bromhexine-containing medicines, reaffirming the small risk of severe allergic reactions and SCARs. The committee recommended that healthcare professionals remain vigilant and report any adverse events associated with Bromhexine use. (ema.europa.eu)
In January 2024, the Indian Ministry of Health and Family Welfare issued a notification emphasizing the importance of pharmacovigilance for mucolytic agents, including Bromhexine. The notification urged manufacturers to strengthen adverse event reporting mechanisms to ensure patient safety.
In February 2024, the Australian Therapeutic Goods Administration (TGA) updated the product information for Bromhexine-containing medicines to include warnings about the risk of severe allergic reactions and SCARs, aligning with EMA recommendations.
In March 2024, the Russian Ministry of Health conducted a review of Bromhexine's safety profile, resulting in updated guidelines for healthcare providers on monitoring and managing potential adverse reactions.
In April 2024, the Iranian Food and Drug Administration (IFDA) issued a circular to pharmaceutical companies, instructing them to update the labeling of Bromhexine products to reflect the risk of severe allergic reactions and SCARs, in line with international regulatory actions.
These developments underscore the global regulatory focus on ensuring the safety of Bromhexine-containing medicines, necessitating continuous monitoring and compliance by manufacturers and exporters.
