Sibutramine

Sibutramine was withdrawn from the U.S. market in October 2010.

Sibutramine affects chemicals in the brain that affect weight maintenance.

Sibutramine is used together with diet and exercise to treat obesity that may be related to diabetes, high cholesterol, or high blood pressure.

Sibutramine may also be used for other purposes not listed in this medication guide.

Sibutramine was withdrawn from the U.S. market in October 2010.

Do not use sibutramine if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use sibutramine before the MAO inhibitor has cleared from your body.

You should not take sibutramine if you are allergic to it, or if you have severe or uncontrolled high blood pressure, an eating disorder (anorexia or bulimia), if you are taking stimulant diet pills, or if you have a history of coronary artery disease, stroke, or heart disease.

Before taking sibutramine, tell your doctor if you have glaucoma, high blood pressure, liver or kidney disease, depression, underactive thyroid, seizures, a bleeding disorder, a history of gallstones, or if you are older than 65 or younger than 16.

Tell your doctor about all prescription and over-the-counter medications you use, especially antidepressants, cold or allergy medication, narcotic pain medicine, or migraine headache medicines.

Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks along with a low calorie diet.

Do not use sibutramine if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use sibutramine before the MAO inhibitor has cleared from your body.

You should not take this medication if you are allergic to sibutramine, or if you have:

• severe or uncontrolled hypertension (high blood pressure);
• an eating disorder (anorexia or bulimia);
• a history of coronary artery disease (atherosclerosis);
• a history of heart disease (congestive heart failure, heart rhythm disorder);
• a history of heart attack or stroke; or
• if you are taking stimulant diet pills.

If you have any of these other conditions, you may need a sibutramine dose adjustment or special tests:

• glaucoma;
• high blood pressure;
• liver disease;
• kidney disease;
• depression;
• underactive thyroid;
• epilepsy or seizure disorder;
• a bleeding or blood clotting disorder;
• a history of gallstones; or
• if you are older than 65 or younger than 16.

FDA pregnancy category C. It is not known whether sibutramine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using sibutramine.

It is not known whether sibutramine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to anyone younger than 16 years old.

Sibutramine is part of the drug class:

• Centrally acting antiobesity products

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Sibutramine falls into category C:

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

OR

There are no well-controlled studies that have been done in pregnant women. Sibutramine should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

OR

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Sibutramine should be given to a pregnant woman only if clearly needed.