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Safety, Regulation, and Quality Concerns From a regulatory perspective, AOD 9604 is not approved by the US FDA, and thus it has no approved medical indications

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Besides the acute phase gastrointestinal effects which may lead to up to 10% of people discontinuing the drugs, there are other potential GI side effects of obstruction, excessive loss of muscle mass, and potentially association with some eye disease adverse events

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J Am Med Assoc 2009;302:211926

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Consequently, they have emerged as promising candidates for a new generation of tumor imaging and therapeutic agents of various CD38-expressing malignancies [85, 88]

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