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MedWatch - The FDA Safety Information and Adverse Event Reporting
Program
BMS notified FDA and
healthcare professionals about proposed changes to
the
prescribing information for Tequin, including an updating of
the
existing
WARNING on hypoglycemia (low blood sugar) and hyperglycemia (high blood
sugar), and a CONTRAINDICATION
for use in diabetic patients. The
changes
also include information identifying other risk factors for developing
low
blood
sugar and high blood sugar, including advanced age, renal
insufficiency, and concomitant glucose-altering medications while
taking
Tequin. The proposed changes are highlighted in the following "Dear
Healthcare Provider" letter issued by
BMS. Specific wording of these
additions and revisions to the labeling is pending FDA review and
approval.
Read
the complete MedWatch 2006 Safety summary, including links to the
Dear
Healthcare Professional letter and proposed
revised label at:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Tequin
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