The authors reply

New England Journal of Medicine

Volumn 362, Issue 6, 2010, Pages 563-

  Woloshin, Steven ^a   Schwartz, Lisa M ^b  

^a DARTMOUTH INSTITUTE FOR HEALTH POLICY AND CLINICAL PRACTICE   (United States)

^b VA MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ZOLEDRONIC ACID;

ADVISORY COMMITTEE; BONE METASTASIS; CLINICAL TRIAL; DISEASE ASSOCIATION; DRUG APPROVAL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG INFORMATION; DRUG LABELING; DRUG MEGADOSE; DRUG SAFETY; ERROR; FOOD AND DRUG ADMINISTRATION; FRACTURE; HUMAN; HYPERCALCEMIA; LETTER; MORTALITY; OFF LABEL DRUG USE; PHYSICIAN; PRIORITY JOURNAL;

EID: 76649136173     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: None     Document Type: Letter

References (4)

1. Major P, Lortholary A, Hon J, et al. Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: a pooled analysis of two randomized, controlled clinical trials. J Clin Oncol 2001;19:558-67.
2. sNDA21-386, Zometa (zoledronic acid for injection). Presented by Novartis to the Food and Drug Administration Oncologic Drugs Advisory Committee, January 31, 2002. (Accessed January 21, 2010, at http://www.fda.gov/ohrms/dockets/ac/ 02/briefing/3827b1.htm.)
3. sNDA21-386, Zometa: appendix 1 - review of zoledronate safety in prostate cancer. Study 039. Presented by Novartis to the Food and Drug Administration Oncologic Drugs Advisory Committee, January 31, 2002. (Accessed January 21, 2010, at http://www.fda.gov/ohrms/dockets/ac/02/briefing/3827b1-04-FDA-Part2%20. htm.)
4. Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance. Arch Intern Med 2009;169:1976-85.