MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

DATE: October 2, 2007

TO: The Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee

FROM: FDA

SUBJECT: Errata to FDA Background document for the advisory committee meeting on October 18 & 19, 2007

The Division of Drug Risk Evaluation (DDRE) provides these corrections to the original background package submitted for the Joint meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee meeting scheduled for October 18 & 19, 2007.

The following items in the FDA Background volume 1, 2^nd Safety Review need to be corrected. Deletions are indicated by strikethrough and corrections are in italics.

Page 3, first bullet, 3^rd & 4^th sub-bullets:

• Approximately 16% 9% of the cases reported a medication error that resulted in a serious adverse event to include prescribing errors, dispensing errors, administration errors, duplication of therapy, and wrong drug administration.
• The manner of overdose could not be determined in the remaining 56% 11% of the cases.

Page 53, seventh bullet, 3^rd & 4^th sub-bullets:

• Approximately 16% 9% of the cases reported a medication error that resulted in a serious adverse event to include prescribing errors, dispensing errors, administration errors, duplication of therapy, and wrong drug administration.
• The manner of overdose could not be determined in the remaining 56% 11% of the cases.