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The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a ...
(The Center Square) – The U.S. Food and Drug Administration has revoked authorization for Red No. 3 in food and ingested drugs in response to a 2022 color additive petition. Safety concerns over ...
The FDA cited in its announcement two studies that linked high levels of red dye No. 3 to cancer in male rats, but stressed that studies in other animals and humans did not show the same effect.
In January 2024, the FDA approved erdafitinib for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy.
This policy was later challenged in court following FDA approval of a food coloring manufactured with a compound known to be carcinogenic, after separate testing indicated that the food coloring itself did not cause cancer in test animals. The United States Court of Appeals for the Sixth Circuit upheld the FDA's approval of the food coloring. [36]
Like many chemotherapy drugs, dacarbazine may have numerous serious side effects, because it interferes with normal cell growth as well as cancer cell growth. Among the most serious possible side effects are birth defects to children conceived or carried during treatment; sterility, possibly permanent; or immune suppression (reduced ability to ...
The FDA’s decision is a victory for consumer advocacy groups and some U.S. lawmakers who have long urged the FDA to revoke Red No. 3’s approval, citing ample evidence that its use in beverages ...
[15] [19] The FDA-approved drug label for thioguanine notes that patients who are TPMT-deficient may be prone to developing myelosuppression and that laboratories offer testing for TPMT deficiency. [20] Indeed, testing for TPMT activity is currently one of the few examples of pharmacogenetics being translated into routine clinical care. [21]