FREQUENTLY ASKED QUESTIONS

ABOUT alli®

  • What is alli®?

    alli® (60 mg orlistat capsules) is the only FDA approved, over-the-counter weight loss product. alli® is indicated for use by overweight adults 18 years of age or older, when used along with a reduced-calorie, low-fat diet. The alli® capsules are supported by a comprehensive weight loss program to help promote a healthy dietary lifestyle and gradual weight loss. Clinical studies have shown that for every 2 pounds you lose through diet and exercise alone, alli® can help you lose 1 pound more.

    See full product information here.

  • Who can take alli®?

    The alli® product can be taken by overweight adults (with a BMI of 25 or above), 18 years or older, when used along with a reduced-calorie, low-fat diet. Please review the label before taking alli®. As with all medicines, please check with your health care professional first if you have questions or concerns. Clinical studies have shown that alli® along with a reduced-calorie, low-fat diet results in greater weight loss than diet alone.

  • Who should not take alli®?

    The alli® product is an important tool for overweight adults who are trying to lose weight. However, our foremost concern with any product is safety.

    The alli® label instructs consumers that it not be used:

    • if you are taking cyclosporine
    • if you had an organ transplant (it may interfere with the medicines used to prevent transplant rejection)
    • if you have been diagnosed with problems absorbing food
    • if you are allergic to any of the ingredients in alli® capsules
    • if you are not overweight
    • if you are pregnant or breastfeeding

    Ask a doctor before use if you ever had:

    • gallbladder problems, kidney stones or pancreatitis

    Ask a doctor or pharmacist before use if you are:

    • taking warfarin (blood thinning medicine). Your medication may need to be adjusted.
    • taking medicine for diabetes or thyroid disease. Your medication may need to be adjusted.
    • taking antiretrovirals (HIV medicine). Your medication may need to be adjusted.
    • taking medicine for seizures.
    • or taking other weight-loss products

    Stop use and ask a doctor if:

    • If you develop itching, yellow eyes of skin, dark urine, or loss of appetite. There have been rare reports of liver injury in people taking orlistat.
    • Severe or continuous abdominal pain occurs. This may be a sign of a serious medical condition.
    • If you are taking medicine for seizures and your seizures happen more often or get worse.
  • Can alli® be used by children or adolescents?

    No. The alli® product is indicated for overweight adults 18 years and older.

  • Can you tell me how many calories per gram of fat are saved by taking alli® capsules?

    Each gram of fat contains 9 calories as compared to 4 calories per gram for carbohydrates and protein. alli® capsules inhibit the absorption of about 25-30% of the fat you consume. So, alli® will save you approximately 2 1/4 calories for each gram of fat you consume.

    For example, if you eat a meal with 20 grams of fat, (9 calories X 20 grams =180 calories of fat), alli® will prevent the absorption of 5 grams of fat (9 calories X 5 grams =45 calories from fat); you will still absorb 15 grams of fat (9 calories X 15 grams =135 calories from fat).

  • How do alli® capsules work?

    The alli® capsule works in the digestive tract and is minimally absorbed in the blood. Orlistat, the active ingredient in alli®, is a lipase inhibitor and works by binding to specific enzymes that break down fats (triglycerides). As a result, about 25% of the consumed fat is not absorbed and passes through the digestive system and is naturally excreted by the body. Since the calories associated with this unabsorbed fat are not used (1 gram of fat=9 calories), the number of calories that enter your system is reduced. Orlistat doesn’t limit the absorption of calories from protein or carbohydrate. So, if you replace calories from fat by eating carbohydrates or protein, you will not get the benefits of alli® and will lose less weight. Therefore, it is important to stick to your calorie and fat target by eating foods that are naturally low in both calories and fat.

  • How effective are alli® capsules?

    alli® (orlistat 60 mg capsules) works by blocking the absorption of about 25% of fat in the foods you eat. Since the calories associated with this unabsorbed fat are not used (1 gram of fat=9 calories), the number of calories that enter your system is reduced. alli® along with a reduced-calorie, low-fat diet can result in a 5% to 10% weight loss over time. alli® meets the rigorous FDA standards for an over the counter weight-loss drug. Clinical trials have consistently shown that alli® along with a reduced-calorie, low-fat diet to be more effective than diet alone. alli® plus diet can help people lose 50% more weight than with dieting alone. This means that if you lose 2 pounds with diet and exercise, alli® can help you lose 1 more.

  • How long does it take for the alli® product to work?

    The first time you take the alli® product along with a reduced-calorie, low-fat meal, it works to inhibit some of the fat you eat. During the first few weeks you may have some trial and error sticking with your recommended fat and calorie target. It’s important to know that although alli® works on an individual meal, if you consume a high fat meal, diet-related side effects may not appear for 12-72 hours since it depends on the time it takes for food to pass through your entire digestive system. This time, known as gastrointestinal (GI) or bowel transit time, is affected by the types of food you eat and how much you drink, and different people can have different bowel transit times.

  • How soon after taking alli® capsules should I expect to see results?

    If you follow a reduced-calorie, low-fat diet, get regular physical activity, and take alli® capsules as directed, you could see results in the first two weeks. Most weight loss usually occurs within the first six months. Individual results vary. If you stop using alli®, continue with your diet and exercise program. You may start to regain weight after you stop taking alli®. You may need to start taking alli® again along with a reduced-calorie, low-fat diet and physical activity.

  • Losing only five percent of one’s initial body weight seems like very little.

    It is important to recognize the health benefits of a five percent weight loss and to change the perception of many Americans who reject this as an insignificant amount of weight loss. A weight loss of five percent can result in significant improvements in overall health, including decreased cardiovascular risk factors. Although a greater weight loss may result in more health benefits, a 5% weight loss is an achievable and realistic starting goal. The alli® brand encourages slow, gradual weight loss and lifestyle changes that can help you achieve and maintain a realistic weight loss goal.

  • How much weight can I expect to lose while taking the alli® product?

    That depends on how closely you follow a reduced-calorie, low-fat diet, get regular physical activity, and take alli® capsules as directed. alli® along with the recommended diet promotes a gradual, modest weight loss of about 1 to 2 pounds a week. For every 2 pounds you lose from diet alone, alli® can help you lose 1 pound more. In clinical studies, most people lost 5-10 pounds over 6 months. Individual results may vary.

  • If alli® capsules only work on the fat in my food, how do I lose the fat in my body?

    alli® capsules work by blocking the absorption of about 25% of fat in the foods you eat. Since the calories associated with this unabsorbed fat are not used (1 gram fat=9 calories), the number of calories that enter your system is reduced. As you consume fewer calories on a reduced-calorie, low fat diet – and use alli® to block absorption of some of the fat you eat – your body will start to use its stored fat to meet its energy needs, which can result in weight loss.

  • Does the alli® product block calories? If alli® is blocking fat isn't it also essentially blocking the calories or reducing my calories?

    Yes. alli® capsules work by blocking the absorption of about 25% of the fat ingested. Consequently, the calories associated with that unabsorbed fat cannot be used. For example, if your meal contains 16 grams of fat, 4 grams (about 25%) will not be absorbed. Since 4 grams of fat are equal to 36 calories, your body takes in 36 less calories.

  • I have read comments that after the first shortage in 2012, the alli® product didn’t work as well.

    The formulation for the alli® product is the same as it was when it was originally launched as an over the counter (OTC) weight loss aid in 2007, and it is manufactured at the same site in the U.S.  alli® contains the same active ingredient, orlistat, at the same levels since its launch in 2007.

  • Can elderly adults take alli® capsules?

    The alli® product is indicated for use by overweight consumers 18 years of age or older, when used along with a reduced calorie and low fat diet. This includes older adults. If you have specific issues or health concerns, please check with your healthcare professional.

  • alli® pills seem to suppress the appetite for other people including some of the people on the message board. Is alli® an appetite suppressant?

    The alli® product is not an appetite suppressant and does not contain any stimulants. alli® does not work in the central nervous system, but instead, works locally in the digestive tract. Some people find that changing their diet to include more fiber, like fruits and vegetables, can make them feel fuller.

  • How is the alli® product different from other weight loss aids?

    alli® is the only FDA-approved weight loss aid available without a prescription. It is not a dietary supplement. Millions of people in the United States and Europe have used alli® since it became available over the counter in 2007. Orlistat (the active ingredient in alli® capsules) is the most extensively studied weight loss ingredient in the world. Its safety has been established through 100 clinical studies involving more than 30 thousand patients. More than 50 million people have used orlistat since it became available in 1997.

  • What is a realistic weight goal?

    Obesity experts in the United States agree and widely available research demonstrates that moderate weight loss of 5-10% is beneficial. It is important to emphasize the health benefits of a moderate weight loss and to change the perception of Americans who reject this as an insignificant amount. A weight loss goal of 5-10% is realistic and achievable and can result in significant improvements in overall health, including a decreased risk for heart disease. Slow, steady weight loss is the healthy way to reduce body fat mass. The alli® brand program encourages lifestyle changes that can help achieve realistic goals of improved health and weight-loss maintenance.

  • How long does orlistat, the active ingredient in alli® capsules remain in your system?

    How long orlistat remains in your digestive tract depends on your gastrointestinal (GI) or bowel transit time, which is the time it takes for food to travel through the digestive tract. GI transit time is influenced by the types of food you eat, how much you drink and biological variations. Therefore, different people have different transit times. For most people the range is between 12-72 hrs. In clinical studies, once orlistat was stopped, baseline levels returned by about 72 hours.

  • Does the alli® capsule begin to work in the stomach, or does it begin to work in the small or large intestine?

    alli® capsules begin to work in the stomach, but the majority of the action occurs in the small intestine.

  • Does the alli® product cause liver damage?

    The alli® label was updated to alert consumers to certain symptoms that have been associated with rare instances of severe liver injury reported in people taking orlistat, the active ingredient in alli®.

    The FDA completed a safety review of orlistat in May 2010 based on reports that were received over a 10-year period. The FDA concluded that a cause and effect relationship has not been established.

    The alli® label advises consumers to “Stop use and ask a doctor if you develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat.” Please contact your physician if you have any questions or concerns.

  • Is the alli® product Kosher?

    No, alli® is not Kosher since the gelatin of the alli® capsule may be of pork origin.

  • What is the specific mg for any of the inactive ingredients?

    The specific amount (mg) is proprietary information. Do not use alli® capsules if you are allergic to any of the ingredients.

  • If you’re on another weight loss plan, is there a benefit to adding the alli® brand?

    The alli® brand is compatible with and may be beneficial to most sensible, weight loss programs as long as the calories from fat are not above 30%. Whether you’re on NutriSystem®, Jenny Craig®, Weight Watchers® or another similar program, alli® can be a good partner. By blocking some of the fat, and therefore the calories you consume, alli® along with a reduced-calorie, low-fat diet can boost your weight loss by 50% over dieting alone. While alli® can work with other low-fat weight loss programs, there is one key thing to keep in mind: balance. alli® is meant to be taken three times a day with well-balanced, reduced-calorie, low-fat meals — so if you like to save most of your points, fat or calories for a big splurge meal, you’ll want to reconsider that practice before adding alli® to your diet program. With alli®, each meal must be within your fat target to minimize the chances of diet-related side effects.

    We do not recommend using alli® with diets that are low in carbohydrates and high in fat (greater than 30% of calories from fat). You can read the Companion Guide (available online) for more information on other diet plans.

  • Can I use the alli® product if my body mass index (BMI) is too low or I have a normal weight?

    The alli® brand is not recommended if your Body Mass Index (BMI) is below 25 kg/m2. alli® is a weight-loss aid intended for individuals who are overweight.

  • Has orlistat, the active ingredient in alli® capsules, been tested among African Americans and Hispanics?

    Yes. In clinical trials, the study population included African Americans and Hispanics. Subjects treated with 60 mg orlistat along with a reduced-calorie low-fat diet had significantly greater weight loss than those on diet alone.

  • What is my BMI? What does my BMI number mean?

    BMI stands for Body Mass Index, a number calculated from a person's weight and height.

    For adults a BMI of

    • less than 18.5 is underweight;
    • 18.5 to 24.9 is normal;
    • 25 to 29.9 is overweight
    • 30 or more is obese

    If your BMI falls within the overweight or obese range and you are 18 years or older, the alli® brand is appropriate for you. You can use the following chart to find your BMI; there also are a number of online BMI calculators.

    Height

    Weight (closest to your own)

    4’11”

    114

    119

    124

    128

    133

    138

    143

    148

    153

    5’0”

    118

    123

    128

    133

    138

    143

    148

    153

    158

    5’1”

    122

    127

    132

    137

    143

    148

    153

    158

    164

    5’2”

    125

    131

    136

    142

    147

    153

    158

    164

    169

    5’3”

    130

    135

    141

    146

    152

    158

    163

    169

    175

    5’4”

    134

    140

    145

    151

    157

    163

    169

    174

    180

    5’5”

    138

    144

    150

    156

    162

    168

    174

    180

    186

    5’6”

    142

    148

    155

    161

    167

    173

    179

    185

    192

    5’7”

    146

    153

    159

    166

    172

    178

    185

    191

    198

    5’8”

    151

    158

    164

    171

    177

    184

    190

    197

    203

    5’9”

    155

    162

    169

    176

    182

    189

    196

    203

    209

    5’10”

    160

    167

    174

    181

    188

    195

    202

    209

    216

    5’11”

    165

    172

    179

    186

    193

    200

    208

    215

    222

    6’0”

    169

    177

    184

    191

    199

    206

    213

    221

    228

    6’1”

    174

    182

    189

    197

    204

    212

    219

    227

    235

    6’2”

    179

    186

    194

    202

    210

    218

    225

    233

    241

    6’3”

    184

    192

    200

    208

    216

    224

    232

    240

    248

    6’4”

    189

    197

    205

    213

    221

    230

    238

    246

    254

    6’5”

    194

    203

    211

    220

    228

    237

    245

    254

    262

    BMI

    23

    24

    25

    26

    27

    28

    29

    30

    31

     

    Normal

    Overweight

    Obese

                           

    To calculate your BMI yourself, the following formula (from CDC) can be used:

    Formula: weight (lb) / [height (in)] 2 x 703

    Calculate BMI by dividing your weight in pounds (lbs) by your height in inches (in) squared and multiplying by a conversion factor of 703.

    Example: Weight = 150 lbs, Height = 5'5" (65")

    Calculation: [150 ÷ (65)2] x 703 = 24.96

  • What does the alli® capsule look like?

    The alli® pill is a turquoise blue capsule with a dark blue band imprinted with the text “60 Orlistat”. It is packaged in a labeled bottle that has an inner foil seal imprinted with the words: “Sealed for Your Protection.”

  • What is the size of the capsule?

    The alli® capsule is 5/8ths of an inch long, and 1/8th of an inch wide.

  • What sizes is the product available in?

    The alli® product is currently available in a 60 and 120 count size. Please visit the product page for updates on additional sizes in the future.

  • What is the proper way to store alli®?

    The label states that alli® capsules should be stored at 20-25 degrees Celsius (or 68-77 degrees Fahrenheit) and that you should protect alli® from excessive light, humidity and temperatures over 30 degrees Celsius (or 86 degrees Fahrenheit). If your bottle of alli® has been exposed to excessive light, humidity or temperatures for prolonged periods of time, we do not recommend that you continue to use it.

  • Are the caps on the bottle child proof?

    The caps on the bottle are intended to be child-proof.

  • How many desiccants are in each of the different sizes of the alli® bottles?

    There are two desiccants in each of the sizes of alli® bottles.

  • What does the alli® product cost?

    Pricing may vary by retailer. GlaxoSmithKline Consumer Healthcare, the manufacturer of the alli® brand, may make recommendations concerning pricing, promotion, shelving, and distribution; however, all decisions are at the sole discretion of the online or retail outlet.

  • Where can I find the alli® product in stores?

    alli® capsules can be purchased online and in many major retail stores in the weight loss product aisle. Authorized retailers and online sites who sell alli® can be found on the alli® website under "Buy alli®"

  • Is the alli® packaging recyclable?

    The bottle and packaging are recyclable, but you may want to check with your local community to find out if your program will recycle these materials.

  • What is Orlistat? Is it derived from an artificial or natural source?

    Orlistat is a drug, also referred to as tetrahydrolipstatin. It was originally identified from a natural source and is now synthesized. Orlistat is known as a lipase inhibitor since it prevents enzymes, known as gastric and pancreatic lipases, from breaking down the fat you consume.

  • Is the alli® product the same as the prescription strength of orlistat?

    The prescription strength and alli® capsules contain the same active ingredient, orlistat, but they are not the same. The products have different indications and dosages. Only alli® is manufactured by GSK. alli® is 60 mg orlistat, an over-the-counter medication indicated for weight loss in overweight adults who follow a reduced-calorie, low-fat diet.

  • Are you planning to discontinue the prescription strength of orlistat?

    GSK does not market or manufacture the prescription strength.

  • How long have you been studying the alli® product?

    The active ingredient in alli®, orlistat, is the most comprehensively tested weight loss drug. Scientists have studied orlistat for over 25 years in more than 100 clinical studies.

  • Is the alli® brand sold in Canada?

    No. The alli® product is not sold or approved in Canada.

  • How much of alli® capsules are absorbed systemically?

    alli® capsules (60 mg orlistat) work in the digestive tract. They are minimally absorbed in the bloodstream and do not have any cumulative effect in the body.

  • I know the gastrointestinal tract is the site of action for alli® capsules, but where is it metabolized? Do alli® capsules metabolize in the liver or kidney?

    alli® weight loss capsules (60 mg orlistat) are metabolized in the gastrointestinal wall. Less than 2% of orlistat is metabolized by the kidneys. The remaining orlistat is cleared through the feces.

  • How long does it take for an alli® capsule to clear a person’s system?

    Most of orlistat, the active ingredient in alli® capsules, is excreted through the feces. How long it takes depends on one’s gastrointestinal (GI) or bowel transit time, the length of time it takes for food to travel through the digestive tract. This can vary between individuals, but, in general, the time to reach complete excretion (fecal and urinary) of orlistat is about 3 days.

  • Where can I get studies that test the efficacy and safety of the alli® capsules?

    The following studies have examined the efficacy and safety of alli® capsules (60 mg orlistat).

    • Rossner, Stephan, Lars Sjostrom, Rudolf Noack, Edo Meinders, and Giorgio Noseda. "Weight Loss, Weight Maintenance, and Improved Cardiovascular Risk Factors After 2 Years Treatment with Orlistat for Obesity." Obesity Research 8.1 (2000): 49-61. 18 Apr. 2007.
    • Anderson, James W., Susan M. Schwartz, Jonathan Hauptman, Mark Boldrin, Maureen Rossi, Vidhu Bansal, and Cecilia A. Hale. "Low-Dose Orlistat Effects on Body Weight of Mildly to Moderately Overweight Individuals: a 16 Week, Double-Blind, Placebo-Controlled Trial." The Annals of Pharmacotherapy 40 (2006): 1717-1723. 18 Apr. 2007.
    • Hauptman, Jonathan, Charles Lucas, Mark Boldrin, and Harry Collins."Orlistat in the Long-Term Treatment of Obesity in Primary Care Settings." Arch Fam Med 9 (2005): 160-167. 18 Apr. 2007
    • Smith SR, Stenlof KS, Greenway FL, McHutchison J, Schwartz SM, Dev VB, Berk ES, Kapikian RSmith SR et al. Orlistat 60 mg reduces visceral adipose tissue: a 24 week randomized, placebo-controlled, multicenter trial. Obesity. 2011 Sep;19(9):1796-803
  • Can I use an HSA or FSA to buy alli® products?

    You can use your HSA and FSA tax-preferred savings account to purchase certain OTC products including alli®. The passage of the CARES Act by Congress includes provisions to restore OTC eligibility under tax-preferred HSA and FSA accounts. Your plan details may vary, so save your receipt and check with your benefits or health provider for eligibility.

    Source: https://www.chpa.org/Monograph_FSA_CARES.aspx

TAKING alli®

  • How should alli® be taken?

    The recommended dose of alli® is one capsule (60 mg orlistat) three times a day with meals containing fat.

    Additionally, to ensure adequate vitamin absorption you should take a multivitamin containing fat soluble vitamins (vitamins A, D, E, K & beta carotene) once a day, at bedtime; alli® may reduce the absorption of fat soluble vitamins.

  • When do I take alli®?

    The mealtime dosing schedule (one hour before, during, or one hour after a meal) makes it easy to remember when to take alli® capsules. To help you remember, we recommend making alli® a part of your pre-meal routine. Once alli® and the routine have been paired several times, the association should become automatic. If a dose is missed, alli® can be taken up to one hour after a meal and still be effective. alli® should only be taken 3 times a day.

  • If I use alli® more than three times daily, will I experience better results?

    No. Additional doses are not recommended. Please read and follow label directions.

  • Can I eat fewer calories than what you suggest for my height and build?

    Yes, however, it is recommended to begin your alli® brand program using the fat and calorie targets recommended. These targets are based on a calculation that estimates your daily caloric needs. Your body needs a certain level of calories to maintain all your body functions and also to provide you with energy. If you are taking alli® and consistently following your diet recommendations and do not lose any weight within two weeks, you may consider reducing your daily calorie intake.

  • Can I use a multivitamin while taking alli®?

    Yes. You should take a multivitamin that contains fat soluble vitamins (vitamins A, D, E, K, and beta-carotene) when using alli® capsules. Because orlistat, the active ingredient in alli®, can reduce the absorption of fat soluble vitamins, we recommend taking a multivitamin once a day, at bedtime to ensure adequate absorption.

  • How long can I take alli®?

    The alli® label does not limit the amount of time you can take alli®. You can take it until you achieve your weight loss goal. Most weight loss occurs within the first six months of using alli®. If you stop taking alli® capsules, continue with your diet plan and physical activity to help maintain your weight. If you start to regain weight after you stop taking the capsules, you may need to start taking them again along with a diet and physical activity.

  • What happens if I forget to take the alli® capsule with my meal?

    The recommended dose of alli® is one capsule three times a day with meals containing fat.  If you miss a dose, you simply lose the benefit of alli® blocking the absorption of some of the fat in that meal.

  • Does the alli® product still work after taking it awhile? Very early on, I had diet-related side effects, but now, I don't even have that, even when I really slip up.

    It's important to keep in mind that not everyone who takes the alli® product experiences a diet-related side effect. Almost 50% of people never experience a diet-related side effect. These effects tend to occur early on when you first start taking alli®, as your body adjusts to your diet and alli®, and then subsides with continued use. Even if you do not experience side effects, alli® is still working to block the absorption of approximately 25% of the fat you consume.

  • Does the alli® product lose effectiveness over time? Very early on, I had diet-related side effects, but now, I don't even have that, even when I really slip up.

    It's important to keep in mind that not everyone who takes the alli® product experiences a diet-related side effect. Almost 50% of people never experience a diet-related side effect. These effects tend to occur when you first start taking alli®. Your body adjusts to your diet and alli®, and side effects often subside with continued use. Even if you do not experience side effects, alli® is still working to block the absorption of approximately 25% of the fat you consume.

  • If I do stop taking the alli® capsules, do you have any recommendations on how to maintain my weight?

    It is important to continue with healthy, well balanced meals that consist of lean proteins, healthy fats, and plenty of fruits and vegetables. Do not skip meals, which can cause overeating later in the day. We recommend that you increase your physical activity to make up for the calorie deficit associated with the alli® capsules. Regular physical activity is recognized as one of the most important aspects in maintaining weight loss. For successful maintainers, the most common form of physical activity is walking (www.nwcr.ws). You also should weigh yourself once a week to monitor whether you have gained any weight.

  • I have regained a few pounds after I stopped taking the alli® capsules? What do I do?

    Don’t let small weight gains become big ones. Here are a few tips for getting back on track

    • Weigh yourself once a week and record your weight
    • Resume recording calories & fat grams in a food journal
    • Add more physical activity
    • In order to maintain your weight loss, you may need to start taking alli® again, along with following a reduced-calorie, low-fat diet.
  • When should I start taking the alli® capsules?

    If you already have tried a diet and exercise program and now have purchased the alli® product, we suggest that you start with a recommended reduced-calorie, low-fat diet for a few days before starting the alli® capsules. If you're already following this type of diet, you can start sooner.

  • Is there a limit to wait in between taking two capsules?

    The recommended dose of alli® is 1 capsule with meals containing about 15 grams of fat and no more than 3 capsules daily. alli® should be taken within an hour of each meal containing fat. It's best to wait at least 2 hours in between doses. Because of the way alli® capsules work, you should not store up all your fat grams or calories for one or two meals. It is recommended that you keep fat grams evenly spread throughout the day in breakfast, lunch, and dinner.

  • If I eat more than three meals a day, should I take additional alli® capsules?

    No. It is recommended that alli® capsules be taken with meals – up to three times a day. Additional doses are not recommended.

  • What happens if I take an alli® capsules with a fat free meal?

    If there is no fat in the meal, alli® capsules will have no effect. alli® only works locally in the gut to block the absorption of dietary fat; it does not cause any bowel changes without the consumption of dietary fat. alli® has no effect on the absorption of carbohydrates or protein.

  • Can I skip meals while taking the alli® capsules?

    Clinical studies show that the alli® product works best when you eat 3 healthy, reduced-calorie, low-fat meals a day, one of which is breakfast. If you skip a meal or you are certain your meal contains no fat, you can skip a dose.

  • The ads say that if I eat 15 grams of fat per meal, I can reduce diet-related side effects. However, the website & books that came with the package said that I should eat more or less. What should I follow?

    The 15 gram target is an example for someone eating a 1400 calorie a day diet. The information provided online and in the Companion Guide provides your specific targets, which will differ depending on your calorie level.

  • What is the least amount of fat a person can eat and still benefit from using the alli® product?

    This question cannot be answered concretely. The alli® brand program is based on a healthy, balanced, reduced-calorie, low-fat diet. It is not recommended that you exclude fat from your diet. If you exclude all fat, there is no reason to take alli® capsules, since the mechanism of action works only by inhibiting fat absorption. You will get the most benefit from alli® by following your fat target per meal.

    alli® inhibits about 25% absorption of fat in your meal, independent of how many grams of fat are in that meal. It is up to you to determine whether your meal has “enough” fat to warrant taking alli® with that meal. If your meal is fat free there is no value in adding alli® to that meal.

    It is important to keep in mind that fat has value in your diet. Dietary fat is important to a number of bodily functions. Vitamins A, D, E and K need dietary fat to be fully absorbed. Certain fats are essential for healthy skin. Having some fat in your meals adds flavor and may help you feel full after eating.

  • I haven't experienced any diet-related side effects yet and I have only lost a few pounds in the first week of taking alli® capsules? Why is alli® not working for me?

    alli® is still working for you even if you are not experiencing diet-related side effects. Side effects are most likely to occur if you eat a meal containing more than your recommended fat gram target (about 30% of total calories). If you are not experiencing these side effects, you are likely following your calorie and fat gram targets. With alli® capsules, you can expect a healthy steady, gradual weight loss of about a pound or two a week beginning within the first two weeks. How much weight you lose will depend on how closely you follow the recommended diet and the alli® program.

  • What tools are available to ensure you use the alli® product correctly?

    GSK offers the following to encourage proper usage:

    • an educational online support program to be used in concert with alli® capsules to encourage appropriate use
    • Educational guides:
  • What if I consume a diet containing more than 15 grams of fat per meal?

    The alli® capsule is recommended for use 3 times daily with meals containing fat. Meals should contain between 12-18 grams of fat depending on your calorie target. Going above your fat target may result in an increased incidence of diet-related side effects, such as loose stools, more frequent stools that may be hard to control, or gas with oily spotting. These bowel changes most often occur in the first weeks of taking alli® capsules and can be manageable by following your recommended daily calorie and fat targets. In controlled clinical trials, only about 3% of subjects on orlistat 60 mg, the active ingredient in alli® capsules, dropped out due to these diet-related side effects. In fact, anecdotally, users have reported that diet-related side effects can serve as a signal to help them adopt healthier eating patterns.

  • Why are you recommending people take the alli® product with a multivitamin? Does it deplete vitamin levels?

    It’s always sensible advice to take a multivitamin when you are on any kind of weight-loss program. Orlistat, the active ingredient in alli® capsules, works by preventing absorption of about 25% of fat; it will also minimally inhibit fat-soluble vitamins to the same extent. The fat-soluble vitamins are vitamins A, D, E, K, and beta-carotene. We recommend that you take a multivitamin with alli®, once a day at bedtime. If you cannot take it at bedtime, we suggest taking it at least 2 hours before or after taking alli®.

  • Is dieting necessary when taking alli® capsules?

    Yes. A well-balanced, reduced-calorie, low-fat diet containing about 15 grams of fat per meal is recommended while taking alli® capsules. These recommendations are consistent with U.S. dietary guidelines (total fat intake between 20% and 35% of calories). Orlistat, the active ingredient in alli® capsules, prevents the absorption of some dietary fat but does not limit the absorption of calories from protein or carbohydrate. So, if you replace calories from fat by eating more carbohydrates or protein, you will not get the benefits of alli® and will lose less weight. Therefore, it is important to stick to your calorie and fat target by eating foods that are lower in both calories and fat.

    Finding your daily calorie range helps you to understand how many calories youneed to stay healthy and still lose weight. Access to a free support tools are available online at myalli.com. These tools were designed in collaboration with weight loss experts to provide advice and support to help you reach your goal while taking alli® capsules.

  • Should alli® capsules be used with diets that are low carbohydrate and high fat?

    No. The alli® product is recommended in conjunction with low-fat diets that contain about 15 grams of fat per meal (or, about 30% of calories from fat). Eating a meal with too much fat while taking alli® can result in bowel changes, such as loose stools, more frequent stools that may be hard to control, or gas with oily spotting. These changes, called diet-related side effects, generally occur during the first few weeks of treatment and can be managed by following your recommended calorie and fat targets.

  • What can you eat on the alli® diet plan?

    Each meal should have 12-18 grams of fat depending on your daily calorie target. The keys are moderation, balance, and eating foods that are low in fat, not NO-fat. Your body needs some dietary fat to remain healthy. Moreover, if your diet is too low in fat, alli® capsules will not be as effective. The recommended alli® diet plan is not about starvation or deprivation; so while it’s important to limit choices that are high in fat and/or calories, you will find that you can still enjoy many of your favorite foods in moderation. Examples of healthy, delicious meals and recipes are available online at www.myalli.com.

  • Can I use the support tools at www.myalli.com without purchasing alli®?

    Yes, the support tools available at www.myalli.com are free. While you can use alli® capsules without using these support tolls, it is not recommended. These tools were developed in collaboration with clinical weight-loss experts to work specifically with alli® capsules, providing feedback and guidance to help you succeed in your weight loss efforts with alli®.

  • Do the alli® support tools accommodate vegetarian diets? Will I be able to tailor my diet specifically to meet my vegetarian lifestyle?

    Yes. A number of meal plans and recipes are offered so you can choose according to your eating preferences. Please note that the alli® capsule and banding kit both contain components that are derived from bovine (cow) origin. Additionally the gelatin of the alli® capsule may be of pork origin. 

  • Does the recommended alli® diet plan work for all cultural cooking styles and traditions?

    People can enjoy great tasting traditional and cultural meals that are low in fat (about 15 grams of fat per meal). The principles are the same across all types of food – it’s about education and learning how to prepare meals in a healthier way. The alli® product program provides this type of education to help teach people how to modify their diet. People can access a host of meal plans and recipes by visiting the alli® website.

  • How much exercise do you recommend doing while taking the alli® product?

    You don’t have to hit the gym or hire a personal trainer to make a real difference in your health. Studies show that moderate physical activity—such as walking for 30 minutes every day—can reduce your risk for disease.

    The great thing about exercise is its cumulative effect—you don’t have to do it all at once. You can add it to your activities throughout the day by sneaking in a little extra walking into the things you already do. What's important is including activity regularly in your routine. Start small and work your way up. Consistency is your goal. 

  • A holiday is coming up. I know I’m going to eat more than 30 percent fat at dinner. Should I double up on alli® capsules?

    No. You should take one alli® capsule with each meal containing fat, but do not take more than 3 capsules daily.  You should not plan to eat high-fat meals when you are trying to lose weight – and that includes holidays. Plan a holiday meal using recipes from the alli website or other low-fat diet programs. As you progress, you will discover new ways of eating that will lead you to automatically start making better choices! That includes the holidays too.

ABOUT WEIGHT LOSS

  • What is dietary fat?

    Fat has more than twice the calories per gram than carbohydrates or protein (9 calories per 1 gram of fat vs. 4 calories per one gram of carbs or protein). Dietary fats, which are the most concentrated source of food energy, are composed chiefly of triglycerides, such as the fat in meats, milk products and vegetable oils.

    Research attributes health risks to certain kinds of dietary fats. For example, it is believed that saturated fats (e.g., animal fats and butter) may be more dangerous to a person’s health whereas polyunsaturated (e.g., corn and soybean oils) and monounsaturated fats (e.g., canola and olive oils) may have a beneficial impact. All fats, however, have the same number of calories and are affected by alli® capsules in the same way.

  • Why is it important to target dietary fat?

    Intake of excessive calories can lead to weight gain. Dietary fat is calorically dense (twice as much per gram than other nutrients) and can quickly lead to excessive calorie intake and weight gain. Weight gain is one of the major risk factors for conditions leading to heart disease and diabetes such as high blood pressure, high cholesterol and elevated glucose levels.

  • Won’t it be difficult for me to determine the amount of fat per meal?

    The support tools available online at www.myalli.com can be very helpful in determining the calorie and fat content of meals, including the calorie and fat content for hundreds of common foods. Weekly menus for the alli® targets of 1200, 1400, 1600 and 1800 calories are also available. Each menu gives you 3 meals a day plus a snack. Just choose the calorie target, and the menu will automatically give you the right number of fat grams each day.

  • Do alli® capsules discriminate between types of fat, or does it prevent the absorption of both good and bad fats?

    Orlistat, the active ingredient in alli® capsules, does not discriminate between types of fat. It prevents the absorption of about 25% of any dietary fat consumed. But remember, eating too much fat, whether it’s “good” or “bad” fat, can contribute to weight gain and possibly result in gastrointestinal (GI) side effects. You should stay within your calorie and fat gram goal for each meal.

  • Many people in the U.S. who are overweight or obese fluctuate up and down in weight. After using the alli® product, do consumers face the same problem?

    The alli® product is proven to help people lose excess weight when used in conjunction with a reduced-calorie, low-fat diet. Along with the online support tools, it can help consumers adapt healthier eating and lifestyle habits they may sustain over the long term.

  • Are there benefits to losing a small amount of weight?

    Yes. Even a five percent reduction in weight can improve health conditions associated with overweight and obesity.

  • What is obesity?

    Overweight and obesity can be defined as an excess accumulation of body fat sufficient to endanger health. Obesity is classified as a disease (not a personal weakness) that requires long-term treatment and management to achieve and sustain weight loss. The impact of overweight and obesity on the risk of disease is influenced by the location of the excess fat. Visceral fat, which is located within the abdominal region, surrounding the internal organs, is associated with a greater health risk than subcutaneous fat, which is located under your skin. Experts agree that the primary cause of overweight and obesity is the excessive intake of calories. Weight gain results when the calories consumed are greater than one’s energy expenditure, the amount of calories that a person needs to burn in order to maintain his/her body weight. When excess calories are not used, the body stores them as body fat. In general, it is easier for the body to store excess calories as body fat if they are consumed as dietary fat. The body does convert excess carbohydrates or protein into body fat, but it takes more energy (calories) than directly storing dietary fat. This is one reason why a high fat diet can be associated with greater weight gain. A number of other factors contribute to overweight and obesity including genetic makeup, environment, socioeconomic status, culture, and psychological status.

  • How is obesity measured?

    The most commonly accepted measurement of overweight and obesity is known as the Body Mass Index (BMI). The BMI is used as an indicator of body fatness and a screening tool to identify possible weight problems for adults. It is calculated by dividing your weight (in kilograms) by the square of your height (in meters). The BMI is graded to indicate the degree of risk to health. For adults 20 years old and older, the BMI is used to establish standard weight status categories that are the same for all ages and for both men and women.

    • BMI < 18.5 (underweight)
    • BMI 18.5-24.9 (desirable weight)
    • BMI 25-29.9 (overweight)
    • BMI 30-40 (obese)
    • BMI >40 (severely obese)

    Other methods in addition to BMI can be used to further access obesity and related disease risk:

    • waist circumference – measures the distribution of abdominal fat, which is well correlated with the risk of developing metabolic and cardiovascular diseases.
    • waist to hip ratio – like waist circumference it is used to measure abdominal obesity to help predict development of disease in adults
    • other measurements of body fat – skin fold tests (skin calipers) and/or body impedance (BIA) methods. Most scales that measure body fat use this latter method.
  • Why does obesity need to be managed?

    Obesity is associated with an increase in serious health risks including:

    • Elevated blood pressure and cholesterol levels
    • Type 2 Diabetes
    • Prediabetes
    • Some forms of Cancer
    • Osteoarthritis
    • Gallstones
    • Respiratory complications, such as increased difficulty in breathing while asleep
    • Reduced quality of life

    If you have a question about obesity and your personal health, check with your doctor.

ABOUT PERSONALIZED TOOLS

SIDE EFFECTS & GUIDELINES

  • Can a person overdose on alli® capsules?

    No. Orlistat, the active ingredient in alli® capsules is minimally (<2%) absorbed in the blood. However, taking more than the recommended dose can increase the likelihood of diet-related side effects. The recommended dosage is one alli®capsule (60 mg) taken orally, three times daily with well-balanced meals that contain no more than 30 percent dietary fat. To ensure compliance, it is recommended patients take alli® capsules with every main meal and that fat grams are distributed across the 3 meals.

  • In clinical studies, what was the drop-out rate due to GI adverse events?

    The drop-out rate due to GI adverse events was < 5% for those subjects taking orlistat 60 mg, the active ingredient in alli®.

  • Does the alli® product have any common side effects?

    The most common side effects are gastrointestinal (GI) and are referred to as diet-related side effects. These effects are related to the way you take the product and how much fat you consume when taking alli® capsules. By understanding how alli® works, you can minimize the chances of experiencing these GI side effects (or diet-related side effects).

    alli® capsules work by blocking the absorption of about 25% of the fat you consume. This undigested fat cannot be absorbed and passes through the body along with the calories in this fat. Eating a meal with too much fat, particularly when you first start taking alli®, may result in bowel movement changes such as oily spotting, loose stools, and more frequent stools that may be hard to control. (You may recognize this unabsorbed fat in the toilet as something that looks like the oil on top of a pizza).

    By following the recommended reduced-calorie, low-fat diet, you can minimize the likelihood of experiencing these GI side effects. Depending on your gender, weight and activity level, the recommended diet will range from 1200 to 1800 calories per day, and fat grams will range from 40 to 60 grams daily. Using the Companion Guide, you can determine your calorie and fat targets.

    Additionally, the support tools available at www.myalli.com can help you in managing the likelihood of experiencing diet-related side effects. With this online support plan created in collaboration with weight loss experts, you can get recipes and meal plans designed specifically to meet your daily calorie and fat targets.

    It's important to keep in mind that not everyone (almost 50%) who takes alli® experiences a diet-related side effect.  If you do experience a GI side effect, it tends to occur early on when you first start taking alli®, as your body adjusts to your diet and alli®, and then subside with continued use. Even if you do not experience GI side effects, alli® is still working to block the absorption of about 25% of the fat you consume. You should stop and ask a doctor if severe or continuous abdominal pain occurs.

    This may be a sign of a serious medical condition.

  • Will the alli® product affect my sleeping pattern?

    No. There has been no evidence from clinical studies to indicate that the alli® product affects sleeping patterns. alli® acts non-systemically and does not affect the central nervous system; consequently, it is not associated with jitteriness or palpitations. If you experience sleep problems, please speak with your doctor.

  • Does taking fiber with your diet help to reduce diet-related side effects?

    There is no conclusive scientific evidence that fiber reduces the diet-related side effects of alli® capsules, although fiber has many benefits to your body. However, eating a reduced-calorie, low-fat diet, with about 15 grams of fat per meal (or 30% calories from fat), can help to manage these side-effects.

  • I have only been using the alli® product for a week and there has been no sign of "spotting" but the gas is a problem at times. Is that a result of taking alli® pills, or my new diet?

    Even simple changes to your diet can result in gas. While the gas could be caused by increased vegetable intake, it may also be associated with your meal when taking alli® capsules. We suggest that you follow your calorie and fat targets for each meal (on average, 15 grams fat per meal). If you continue to experience just gas, it likely is related to changes in your diet; your body should adjust with time.

  • Are there any OTC options available for the any gas that I may experience while I am taking alli® capsules?

    Yes. There are OTC options available for gas caused by the foods you eat, including products containing the active ingredient, simethicone. Check with your pharmacist to figure out which is best for you.

  • Is there any connection between the alli® product and colitis?

    No. In clinical studies, orlistat, the active ingredient in alli® capsules, has not been associated with colitis. If you are under a doctor’s care for a serious condition (past or present), it is a good idea to speak with your doctor before making significant dietary changes or taking a new medication.

  • Does taking alli® capsules affect GERD (gastro esophageal reflux disease)?

    No, orlistat, the active ingredient in alli® capsules, does not affect GERD or drugs used to treat GERD such as omeprazole, antacids (calcium carbonate, ranitidine, cimetidine, famotidine). If you have any concerns, you should speak with your health care professional.

  • I have heard that some types of fat are more likely than others to cause diet-related side effects. Is this true?

    We do not have any studies to show this. However, some alli® users find there are certain fats that are more likely to cause more diet-related side effects than others. Foods high in oil content (especially those that are fried) such as french fries, fried chicken, sausage, and butter are all examples of foods that are more likely to trigger these side effects whereas fat that is contained in dairy products like yogurt, cheese and milk are less likely to cause diet-related side effects.

  • Why is the oil excreted during a diet-related side effect different colors?

    Oils are excreted in different colors based on the kinds of foods or concomitant medications that are consumed. Foods containing high amounts of lycopenes (tomato juice/soup, ketchup) or high amounts of food coloring are examples of foods that would likely discolor oil. Additionally foods include: darkly pigmented foods (blueberries, beets), red gelatin, popsicles, spinach, black licorice, even Oreos. Some OTC medications that may do this are coated aspirin, Pepto-Bismol® (medicines containing bismuth) and iron pills.

  • I only ate 1 high fat meal and I have had a diet-related side effect that lasted 36-48 hours. Why is that?

    People have very variable gastrointestinal (GI) transit times, which is the time it takes for your food to completely pass through your digestive tract. Since GI transit times can vary anywhere from 12-72 hours, it can take 48 hours to clear all of the free oil from a meal you took earlier.

  • If I decide to go out for a meal which I know will be very high in fat, can I just not take the capsule with that meal & be ok? Or, will I still be likely to experience a diet-related side effect from the alli® pill that I took earlier in the day?

    Diet-related side effects are mainly a result of eating too much fat in a meal. The alli® capsule works on the meal you take it with, but you may get some effect up to 2 hours. If your next meal is more than 2 hours later, it will not work on that meal.

  • Why do I still get diet-related side effects or oily stools when I stay within the calorie and fat limits?

    alli® capsules work by preventing the absorption of about 25% of the fat in the foods you eat. This undigested fat passes through the body and is excreted in the feces. You may see some oil (like oil on the top of a pizza) in the toilet or in your stool during the first few weeks you take alli®. This is just the undigested fat and is not harmful. Other diet-related side effects may include oily spotting, loose stools, and more frequent stools that may be hard to control. Most of these effects are related to the way you take the product and how much fat you consume when taking alli®. Not everyone experiences diet-related side effects. Studies with orlistat, the active ingredient in alli® capsules, have shown that, on average, eating about 15 grams of fat per meal (or, 30% of calories from fat) will lower your chance of experiencing these effects. However, not everyone’s digestive tract is the same. Some people may be more sensitive to the extra fat in their colon and could have some GI side effects even when keeping within their fat target, especially when first starting alli®. If you are experiencing diet-related side effects, you may want to keep a food diary for a few days to ensure the fat intake is not above your target. If you are following the fat recommendation and still experiencing side effects, you may want to lower the fat gram intake until the effects are resolved.

  • Can taking the alli® product cause hair loss?

    There is no data to suggest a link between orlistat, the active ingredient in alli® capsules, and hair loss. However, some people who are dieting do not consume enough vitamins/minerals necessary for hair/skin/nail health. When taking alli®, you should take a daily multivitamin, at bedtime.

  • What is the difference between diarrhea and diet-related side effects?

    Diet-related side effects occur as a result of consuming high amounts of fat (>60g/day) when taking alli® capsules. alli® blocks about 25% of the fat you eat from being absorbed; this unabsorbed fat passes through your digestive tract and is eliminated. If there is too much unabsorbed fat, this excess fat may result in diet-related side effects such as gas with oily spotting, loose stools or more frequent stools. In contrast to diet-related side effects, diarrhea is a term referring to frequent, loose watery stools and can result in electrolyte imbalance and dehydration.

  • Are there any OTC remedies available to solve diet-related side effects?

    No. Diet-related side effects are related to the way the product works and how much fat you consume when taking alli® capsules. There are no known OTC remedies available that will impact or decrease the occurrence of diet-related side effects.

  • Can I take Imodium to reduce diet-related side effects?

    No. Diet-related side effects are related to the way the product works and how much fat you consume when taking alli® capsules. Agents like Imodium (Loperamide HCl) work by slowing down the passage of stool through the intestine and by reducing the absorption of water and electrolytes from the digestive tract. Since alli® does not cause diarrhea and does not affect intestinal motility and electrolyte imbalance, Imodium would be ineffective for diet-related side effects.

  • Why am I constipated after taking the alli® product?

    It is not uncommon to experience constipation when you start following the alli® brand program. It may be related to what you are eating and drinking, for example, starting a new diet or not drinking enough fluids. Reduced physical activity also may increase the chance of constipation. We recommend using the alli® product as directed and include foods that are high in fiber such as fruits and vegetables and whole grains.

  • Can I take supplements such as Vitamin E and Flaxseed Oil when taking alli® capsules?

    Yes. If your doctor has advised taking fat-based supplements, we recommend they be taken at least two hours before or after taking your alli® capsule. You still should take a multivitamin at bedtime as directed in the alli® label. Note that if you are taking large amounts of these fat-based supplements, the amount of fat should be counted as part your daily fat intake.

INTERACTIONS & WARNINGS