XENICAL

XENICAL (orlistat) is a lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats. Orlistat is (S)-2-formylamino-4-methyl-pentanoic acid (S)-1-[[(2S, 3S)-3-hexyl-4-oxo-2-oxetanyl] methyl]-dodecyl ester. Its empirical formula is C29H53NO5, and its molecular weight is 495.7. It is a single diastereomeric molecule that contains four chiral centers, with a negative optical rotation in ethanol at 529 nm.

Do not take this medication if you are allergic to orlistat, or if you have gallbladder problems, or chronic malabsorption syndrome (an inability to absorb food and nutrients properly). Before taking orlistat, tell your doctor if you have an underactive thyroid, a history of gallstones or pancreatitis, type 1 or type 2 diabetes, an eating disorder, liver disease, or if you take other weight-loss medications (prescription or over-the-counter).

Do not give over-the-counter orlistat (Alli) to a child younger than 18 years old. Prescription orlistat (Xenical) should not be used by anyone age 12 to 18 without the advice of a doctor. Orlistat should be used only by the person it was prescribed or recommended for. Never share orlistat with another person, especially someone who has a history of eating disorder. Keep the medication in a place where others cannot get to it. Orlistat is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.

Avoid a diet that is high in fat. High-fat meals taken in combination with orlistat can increase your risk of unpleasant side effects on your stomach or intestines.

Do not take Xenical if you are allergic to orlistat, or if you have:

• chronic malabsorption syndrome (an inability to absorb food and nutrients properly); or
• gallbladder problems.

If you have any of these other conditions, you may need adjust your dose of Xenical or have special tests:

• an underactive thyroid;
• a history of gallstones;
• a history of pancreatitis;
• liver disease;
• type 1 or type 2 diabetes;
• an eating disorder (anorexia or bulimia); or
• if you take any other weight-loss medications (prescription or over-the-counter).

If you have any of these conditions, you may not be able to use Xenical, or you may need a dosage adjustment or special tests during treatment.

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Do not take Orlistat if you are pregnant. If you become pregnant, contact your doctor. It is not known if Orlistat is found in breast milk. Do not breast-feed while taking Orlistat. Orlistat Pregnancy Warnings
Orlistat has been assigned to pregnancy category B by the FDA. High-dose animal studies have failed to reveal evidence of embryotoxicity or teratogenicity. There are no controlled data in human pregnancy. The manufacturer does not recommend the use of orlistat during pregnancy.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking Xenical can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not use Xenical without telling your doctor if you are breast-feeding a baby.

Xenical Risks
Xenical® (orlistat) is a prescription medicine approved as a weight loss aid. In order to help ensure safe treatment, the risks associated with this medication should be reviewed with your healthcare provider before treatment begins.

Since Xenical may not be suitable for everyone; it is important that you talk to your healthcare provider before taking this drug if you have:

• Had an organ transplant
• Diabetes
• A thyroid disorder
• A medical problem that decreases your ability to absorb food
• Gallbladder problems
• An eating disorder, such as anorexia nervosa or bulimia
• Had kidney stones
• Had pancreatitis.

It is also important to be aware of the potential side effects of Xenical. In clinical studies, a number of intestinal-related side effects were reported with Xenical, including:

• Oily spotting (uncontrolled anal oil seepage)
• Abdominal pain (stomach pain) or discomfort
• Gas with a small amount of oil or stool
• Fecal urgency (an urgent but controlled need to have a bowel movement)
• Fatty or oily stool
• Oily evacuation (bowel movements of just oil, without stool)
• Increased frequency of bowel movements
• Nausea
• Uncontrolled, spontaneous bowel movements.

Common Side Effects of Xenical
Xenical has been studied thoroughly in clinical trials. In these studies, the side effects that occur in a group of people taking the drug are documented and are then compared to side effects that occur in another group of people not taking the medicine. This way, it is possible to see what side effects occur, how often they appear, and how they compare to the group not taking the medicine.

In these studies, side effects that affected the digestive system were common (as would be expected, based on how Xenical works). These side effects included:

• Oily spotting (uncontrolled anal oil seepage) -- in up to 26.6 percent of people
• Abdominal pain (stomach pain) or discomfort -- up to 25.5 percent
• Gas with a small amount of oil or stool -- up to 23.9 percent
• Fecal urgency (an urgent but controlled need to have a bowel movement) -- up to 22.1 percent
• Fatty or oily stool -- up to 20 percent
• Oily evacuation (bowel movements of just oil, without stool) -- up to 11.9 percent
• Increased frequency of bowel movements -- up to 10.8 percent
• Nausea -- up to 8.1 percent
• Uncontrolled, spontaneous bowel movements (known as fecal incontinence) -- up to 7.7 percent.

Many of the side effects of Xenical that affect the digestive tract can be avoided or reduced by decreasing the amount of fat in your diet. Because Xenical decreases the absorption of fat, more fat stays in the digestive tract, causing many of the bothersome and sometimes embarrassing side effects. You are more likely to experience these problems if you eat too much fat. As you continue to take Xenical, you will learn how different foods and different amounts of fat affect you. In fact, in studies, these side effects occurred much less commonly in the second year of treatment. If you have consumed a meal that is high in fat and have taken Xenical, you may want to prepare for possible side effects.

Other common side effects (occurring in 4 to 40 percent of people) included:

• The flu
• A respiratory tract infection (such as the common cold)
• Headaches
• Back pain
• Fatigue
• Menstrual irregularity
• Anxiety
• Ear infection.