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Abbott Statement on the FDA Advisory Committee Recommendation on Sibutramine
Date:9/15/2010

ormation.

UseMeridia (sibutramine hydrochloride monohydrate) is a prescription medicine used to help overweight or obese people lose weight.  Meridia should be used together with a low-calorie diet.

Important Safety InformationMeridia is not for everyone.  People should not take Meridia if they"

  • have or have had, heart problems, including:
  • heart attack
  • chest pain
  • heart failure
  • fast or irregular heart beat
  • hardening of their arteries or other blood vessels
  • poor circulation in their legs
  • have or have ever had a stroke or symptoms of a stroke.
  • uncontrolled or poorly controlled blood pressure (above 145/90).
  • are over age 65.
  • are taking or have taken a type of medicine used to treat depression called a monoamine oxidase inhibitor (MAOI) in the past 2 weeks.  MAOIs should not be taken for at least 2 weeks before using Meridia.  MAOIs should not be taken for at least 2 weeks after stopping Meridia.  People should ask their doctor or pharmacist if they are not sure if any of their medicines are MAOIs.
  • have an eating problem called anorexia nervosa or bulimia nervosa.
  • are taking certain other weight loss medicines.
  • are allergic to sibutramine hydrochloride monohydrate or any other ingredients in Meridia.

  • Meridia can cause serious side effects including large increases in blood pressure or heart rate (pulse) in some people.  Patients should call their doctor right away if they check their blood pressure and it is higher than normal for them, or if they have symptoms of high blood pressure such as headache, dizziness or blurred vision.

    Before starting Meridia, patients should have their blood pressure and heart rate checked by their doctor.  Their doctor should continue checking their blood pressure regularly while taking Meridia.  It is important that patients have regular check-ups with
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    SOURCE Abbott
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