Find risk evaluation and mitigation strategy (REMS) examples for products with a boxed warning for hepatotoxicity.
Product labels are publicly available but searching for references to hepatotoxicity within a specific section across all approved product labels is a challenge. In addition, conducting secondary searches on the identified products means finding other types of documents from different databases.
With our centralized regulatory research platform, all product labels and review packages released by regulatory agencies can be queried at once. Filters can be used to limit the search to a specific section of a document and findings can be quickly confirmed and validated. When the results have been reviewed, content related to the product list of interest can be further queried to gradually build upon the findings.
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Query the database for “hepatotoxicity”
Review the results and confirm the list of relevant products
Search all content associated with the identified products for REMS
Hepatotoxicity is referenced in the labels of 537 FDA-approved products. In 76% of cases, the reference occurs in the Warnings & Precautions section. Only 44 products were found to be associated with hepatotoxicity based on the boxed warning section. When split by therapeutic area, 43% were oncology products with breast cancer and squamous cell carcinoma as the top associated indications. By product class, 25% were antineoplastic agents and 11% were analgesics. (Figure 1)
Figure 1: Top therapeutic classes of FDA-approved products with a boxed warning for hepatotoxicity
Out of the 44 identified products, 14 were found to have risk evaluation and risk mitigation review documents available, and 8 had REMS documents available. (Table 1)
Table 1: List of products with a boxed warning for hepatotoxicity and REMS documents
|Brand Name||Generic Name|
|APADAZ||acetaminophen; benzhydrocodone hydrochloride|
From this group of 8 products with available REMS documents and a boxed warning for hepatotoxicity, 6 REMS programs were confirmed to be related to hepatotoxicity concerns and 5 of them were still active.
In comparing these findings to the results obtained through another tool, 2 out of the 8 products could only be identified using our platform. These 2 products were manually confirmed to have REMS documents associated with the hepatotoxicity risks listed in the boxed warning.