Erratum for Ladewski et al., J Clin Oncol 21 (20) 3859-3866.

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ERRATUM

The Demetri report of the GIST trial (reference 37) reported an incidence of gastrointestinal or intraabdominal hemorrhage of 5% for Imatinib, which was incorrectly placed in table 1 as 1 in 5 or 20%.

In addition, the placement of the reference for epoetin alpha in the second full paragraph on page 3862 may be misleading. As located, readers may believe that all eight warnings are located in this reference, while it only refers to the warning for epoetin alpha. This reference should be located in the fourth full paragraph on page 3862, so that the paragraph reads as follows:

In the United States, pharmaceutical manufacturers and distributors mailed Dear Doctor letters to physicians describing 12 serious ADRs, which occurred within 2 years of FDA approval (four ADRs), more than 2 years and less than 6 years after FDA approval (three ADRs), and between 6 and 25 years after FDA approval (five ADRs).^41-51 Seven of the 11 ADRs (64%) described in black box warnings or contraindications are described in Dear Doctor letters. One ADR, erythropoietin-associated pure red cell aplasia, was described in Dear Doctor letters and PI revisions if Europe, Canada, and Australia in 2001, but not until 2002 in the United States (Procrit [epoetin alfa; package insert], Bridgewater, NJ; Ortho Biotech LP, 2002). One ADR, oprelvekin-associated papilledema in children, was described in a Dear Doctor letter, but not in the PI nor in a peer-reviewed journal article.⁴⁵

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				I. A. Olivotto, V. Bernstein, P. T. Truong, and J. S. Kelly In Reply: J. Clin. Oncol., February 1, 2005; 23(4): 932 - 933. [Full Text] [PDF]

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