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BARACLUDE(R) (entecavir) Data Continue to Demonstrate Low Incidence of Resistance Through Five Years of Treatment in Nucleoside-naive Chronic Hepatitis B Patients
Date:3/24/2008

damaging the liver. BARACLUDE does not cure HBV or stop the spread of HBV to others. People should not take BARACLUDE if they are allergic to it or any of its ingredients. BARACLUDE has not been studied in children and is not recommended for anyone less than 16 years of age.

People taking BARACLUDE should tell their healthcare provider right away if they feel very weak or tired, have unusual muscle pain, have trouble breathing, have stomach pain with nausea and vomiting, feel cold -- especially in their arms and legs, feel dizzy or lightheaded, or have a fast or irregular heartbeat, as they may be signs of a serious condition called lactic acidosis (buildup of an acid in the blood). Lactic acidosis is a medical emergency and must be treated in the hospital. Some people who have taken medicines like BARACLUDE have developed serious liver problems called hepatotoxicity. This may occur with liver enlargement (hepatomegaly) and fat in the liver (steatosis).

People should call their healthcare provider right away if they get any of the following signs of liver problems: yellowing (jaundice) of the skin or the white part of the eyes, darkening of the urine, lightening in the color of bowel movements (stools), not feeling like eating food for several days or longer, feeling sick to the stomach (nausea), or having lower stomach pain. Lactic acidosis and hepatotoxicity have happened in some people taking medicines like BARACLUDE.

For people taking BARACLUDE who have or get HIV (the virus that can cause AIDS) and are not taking medicines for HIV at the same time, some HIV treatments that they may take in the future may be less likely to work. People are advised to get an HIV test before starting to take BARACLUDE and anytime that there is a chance they were exposed to HIV. BARACLUDE will not help HIV infection.

In some people, hepatitis B symptoms may get worse or become very serious when they stop taking BARACLUDE. People should not stop BARACLUDE
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SOURCE Bristol-Myers Squibb
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