Primary source: form
The FDA has advised the public not to purchase or use MAXMAN Coffee due to hidden drug ingredients discovered through laboratory analysis.
Undisclosed ingredients like sildenafil and tadalafil in MAXMAN Coffee pose serious health risks, especially for individuals with certain medical conditions or those taking medication that may interact with these substances.
Enhanced monitoring for products with hidden drug ingredients is required, leading to increased need for rapid reporting and investigation of adverse events associated with similar products.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Enhanced monitoring for products with hidden drug ingredients is required, leading to increased need for rapid reporting and investigation of adverse events associated with similar products.
The FDA has issued a warning about MAXMAN Coffee, confirming the presence of sildenafil and tadalafil, which are not listed on the product label. These ingredients, found in prescription medications for erectile dysfunction, can dangerously interact with certain medications and health conditions. Consumers are advised to refrain from using this product.
What changed: The FDA has advised the public not to purchase or use MAXMAN Coffee due to hidden drug ingredients discovered through laboratory analysis.
Why it matters: Undisclosed ingredients like sildenafil and tadalafil in MAXMAN Coffee pose serious health risks, especially for individuals with certain medical conditions or those taking medication that may interact with these substances.
Practical implication: Enhanced monitoring for products with hidden drug ingredients is required, leading to increased need for rapid reporting and investigation of adverse events associated with similar products.
Published from the regulator source ingestion pipeline after PV impact triage.
Ensure that all labeling and safety information reflects the updated product name 'Prasugrel Viatris' instead of 'Prasugrel Mylan'.
The program will implement collaborative processes for the evaluation of technologies, enhancing real-world evidence integration into signal management and impacting regulatory compliance workflows.
Operational support will now be increased for disease surveillance, health worker assistance, and community outreach based on the new funding and response framework.
Applicants must adhere to new timelines: submit a rapporteurs' allocation request 9 months prior to the intended MAA submission date, and submit their Letter of Intent at least 2 months before the MAA submission.
