Findings from Confirmatory Testing
To-date, confirmatory test results have revealed that certain FPPs formulated with mifepristone, moxifloxacin or ritonavir do contain nitrosamines at levels exceeding acceptable intake limits established according to the Carcinogenic Potency Categorization Approach (CPCA), adopted by regulatory agencies collaborating under the Nitrosamines International Technical Working Group (NITWG).
Interim Measures
Based on benefit-risk considerations, PQT/MED has determined that affected FPP batches may continue to be released under interim acceptable limits, since the risk to the patient associated with interruption of treatment far outweighs any potential future cancer risk associated with nitrosamines present in the products at these levels. These interim limits will remain in place while manufacturers pursue corrective actions or conduct toxicological studies (e.g., enhanced AMES assay tests or other) that may support a higher acceptable intake/limit. PQT/MED will keep monitoring this ongoing work by manufacturers.