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Treatment regimens used for patients with AML can also lead to severe granulocytopenia and an increased risk of serious infections

The monitoring protocol is well-established because the drug has been in clinical use for years

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FDA's stated reasons: Immunogenicity risk Could trigger immune reactions Impurities Compounded versions may be contaminated Lack of characterization Don't fully understand the molecules No human safety data Haven't been properly tested Reported adverse events Some have documented side effects The DOJ Prosecution: $1.79 Million Forfeiture In a landmark case, the Department of Justice prosecuted Tailor Made Compounding LLC for distributing unapproved peptides including BPC-157