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Dee
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA and Aventis Pharmaceuticals revised the CLINICAL PHARMACOLOGY,
PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of labeling, describing
the need for a dosage adjustment for patients with severe renal impairment
(creatinine clearance <30mL/min) who have increased exposure to enoxaparin.
No specific dosage adjustment is required in patients with mild or moderate
renal impairment and in low-weight patients. However, low-weight patients
should be observed carefully for signs and symptoms of bleeding.
Read the MedWatch 2004 safety summary, including links to the "Dear
Healthcare Professional" letter and the revised professional labeling, at:
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#lovenox
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Thank you for using MedWatch as a trusted source for timely safety information on drugs and other medical products regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch. They can learn more about us and subscribe/unsubscribe to the e-list at the MedWatch homepage, http://www.fda.gov/medwatch or by going directly to http://list.nih.gov/cgi-bin/wa?SUBED1=medwatch&A=1
FDA and Aventis Pharmaceuticals revised the CLINICAL PHARMACOLOGY,
PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of labeling, describing
the need for a dosage adjustment for patients with severe renal impairment
(creatinine clearance <30mL/min) who have increased exposure to enoxaparin.
No specific dosage adjustment is required in patients with mild or moderate
renal impairment and in low-weight patients. However, low-weight patients
should be observed carefully for signs and symptoms of bleeding.
Read the MedWatch 2004 safety summary, including links to the "Dear
Healthcare Professional" letter and the revised professional labeling, at:
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#lovenox
--------
Thank you for using MedWatch as a trusted source for timely safety information on drugs and other medical products regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch. They can learn more about us and subscribe/unsubscribe to the e-list at the MedWatch homepage, http://www.fda.gov/medwatch or by going directly to http://list.nih.gov/cgi-bin/wa?SUBED1=medwatch&A=1
