Alli side effects 2015

alli

Generic Name: orlistat (OR li stat)
Brand Names: alli, Xenical

Medically reviewed by Sanjai Sinha, MD Last updated on Jun 17, 2019.

  • Overview
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What is alli?

alli (orlistat) blocks some of the fat that you eat, keeping it from being absorbed by your body.

alli is used to aid in weight loss, or to help reduce the risk of regaining weight already lost. This medicine must be used together with a reduced-calorie diet. Orlistat is for use only in adults.

Xenical is the prescription-strength form of orlistat. The alli brand of orlistat is available without a prescription.

Important information

Do not take alli if you are pregnant. Weight loss is not recommended during pregnancy.

You should not use alli if you have a digestive disorder (problems absorbing food). Do not use alli if you have had an organ transplant, if you use cyclosporine, or if you are not overweight.

alli 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.

Before taking this medicine

You should not use alli if you are allergic to orlistat, or if you have malabsorption syndrome (an inability to absorb food and nutrients properly).

You also should not use Xenical if you have:

  • gallbladder problems; or

  • if you are pregnant.

Do not use alli if:

  • you are not overweight;

  • you have had an organ transplant; or

  • you use cyclosporine (to prevent organ transplant rejection).

To make sure alli is safe for you, tell your doctor if you have ever had:

  • kidney stones;

  • gallbladder disease;

  • pancreatitis;

  • underactive thyroid;

  • liver disease;

  • kidney disease; or

  • an eating disorder (anorexia or bulimia).

Do not use alli if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight. Stop taking orlistat and tell your doctor right away if you become pregnant.

Taking orlistat can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not use this medicine without a doctor’s advice if you are breast-feeding a baby.

Do not give alli to anyone under 18 years old.

How should I take alli?

Use alli exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never share orlistat with another person, especially someone with a history of eating disorders.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

alli is usually taken 3 times per day with each main meal that contains some fat (no more than 30% of the calories for that meal). You may take the medicine either with your meal or up to 1 hour after eating.

If you skip a meal or you eat a meal that does not contain any fat, skip your alli dose for that meal.

The fat content of your daily diet should not be greater than 30% of your total daily caloric intake. For example, if you eat 1200 calories per day, no more than 360 of those calories should be in the form of fat.

Read the label of all food items you consume, paying special attention to the number of servings per container. Your doctor, nutrition counselor, or dietitian can help you develop a healthy eating plan.

alli 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.

Orlistat can make it harder for your body to absorb certain vitamins, and you may need to take a vitamin and mineral supplement while you are taking orlistat. Follow your doctor’s instructions about the type of supplement to use. Take the supplement at bedtime, or at least 2 hours before or after you take alli.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed. Throw away any unused alli after the expiration date on the medicine label has passed.

Keep track of your medicine. Orlistat is a drug that may be misused as a weight-loss aid, and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but no more than 1 hour after eating a meal. If it has been more than an hour since your last meal, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking alli?

Avoid eating high-fat meals or you could have unpleasant side effects on your stomach or intestines.

If you also take cyclosporine, do not take it within 3 hours before or 3 hours after you take orlistat.

If you also take levothyroxine (such as Synthroid), do not take it within 4 hours before or 4 hours after you take orlistat.

alli side effects

Get emergency medical help if you have signs of an allergic reaction to alli: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using alli and call your doctor at once if you have:

  • severe stomach pain;

  • severe pain in your lower back;

  • blood in your urine, painful or difficult urination;

  • kidney problems – little or no urinating; swelling in your feet or ankles; feeling tired or short of breath; or

  • liver problems – nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common alli side effects caused by its fat-blocking action. These are signs that the medicine is working properly. These side effects are usually temporary and may lessen as you continue using alli:

  • oily or fatty stools;

  • oily spotting in your undergarments;

  • orange or brown colored oil in your stool;

  • gas and oily discharge;

  • loose stools, or an urgent need to go to the bathroom, inability to control bowel movements;

  • an increased number of bowel movements; or

  • stomach pain, nausea, rectal pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect alli?

Ask a doctor or pharmacist if it is safe for you to use alli if you are also using any of the following drugs:

  • amiodarone;

  • insulin or oral diabetes medicine;

  • HIV or AIDS medications;

  • seizure medicine (especially if your seizures get worse while taking orlistat);

  • a vitamin or mineral supplement that contains beta-carotene or vitamin E; or

  • a blood thinner – warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may interact with orlistat, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use alli only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Alli Diet Weight Loss Supplement Pills, Orlistat120.0ea

NOTICE: Sale of alli is age restricted. Walgreens.com can not deliver this product to individuals under the age of 21. The age of the recipient will be verified upon delivery. Do not order if you can not verify your age upon delivery.

alli (orlistat 60 milligram capsules) is your smart edge for weight loss. Among weight loss products, it’s the only FDA-approved over-the-counter weight loss aid. Orlistat, the active ingredient in alli, is a lipase inhibitor and works by binding to specific enzymes that break down fats. As a result, about 25 percent of the fat you consume is not absorbed and passes through the digestive system. Since the calories associated with this unabsorbed fat are not used, the number of calories that enter your system is reduced. You’re ready with alli by your side.

Read and follow label directions. alli orlistat 60 mg capsules weight loss pill refill pack (120 capsules) contains: A read me first brochure and up to 40-day supply. It is designed for people who are already using alli and have previously purchased the starter pack. Helps you lose more weight than dieting alone. Read the enclosed brochure for other important information.

Diet and exercise are the starting points for any weight loss program.

Made in India

Read the enclosed brochure for other important information. Diet and exercise are the starting points for any weight loss program. Try these first before adding orlistat. Check with your doctor before starting any exercise program.

To see if orlistat capsules are right for you, find your height on the chart. You may consider starting a weight loss program with orlistat if you weight is the same or more than the weight shown for your height.

For overweight adults 18 years and older: Take 1 capsule with each meal containing fat.

Do not take more than 3 capsules daily. Use with a reduced-calorie, low-fat diet and exercise program until you reach your weight loss goal. Most weight loss occurs in the first 6 months. If you stop taking orlistat, continue with your diet and exercise program. If you start to regain weight after you stop taking orlistat, you may need to start taking orlistat again along with your diet and exercise program. Take a multivitamin once a day, at bedtime, when using orlistat.

Store at 20 – 25 degrees C (68 – 77 degrees F). Protect drug from excessive light, humidity and temperatures over 30 degrees C (86 degrees F).

©

2015 GSK group of companies or its licensor.

Alli

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 11/29/2018

Alli (orlistat) Capsules works by blocking absorption of 25% of the fat in a meal and is used for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet. Common side effects of Alli include:

  • changes in your bowel function because of the unabsorbed fat,
  • fatty/oily stool,
  • oily spotting in your undergarments,
  • orange or brown colored oil in your stool,
  • intestinal gas with discharge,
  • loose stools,
  • a feeling of needing to have a bowel movement right away,
  • increased number of bowel movements,
  • poor bowel control,
  • stomach pain,
  • nausea,
  • vomiting,
  • diarrhea, or
  • rectal pain.

These side effects of Alli may worsen if you eat more fat than you should. Other side effects of Alli include:

Stop taking Alli and tell your doctor if you have rare but serious side effects including:

  • symptoms of liver disease (such as persistent nausea and vomiting, severe stomach or abdominal pain, dark urine, yellowing eyes or skin), or
  • symptoms of kidney stones (such as back pain, pain when urinating, pink or bloody urine).

The recommended dose of Alli for overweight adults 18 years and older is 1 60-mg capsule with each meal containing fat, not to exceed 3 capsules daily. Use with a reduced-calorie, low-fat diet. Alli may interact with warfarin, cyclosporine and medicines for thyroid disease. Tell your doctor all prescription and over-the-counter medications and supplements you use. Alli is not recommended for use during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Alli (orlistat) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

By now, you have probably seen the commercials or read the direct mail pieces about Alli. They ask if you are ready to commit to a weight loss plan that includes Alli, the over-the-counter version of the FDA-approved fat blocker formerly known as Xenical.

The name has changed — and the over-the-counter version is one-half the strength of Xenical — but it’s the same drug. And it has some of the same problematic side effects that plagued its prescription-strength predecessor — gas with oily discharge, inability to control bowel movements, oily or fatty stools, and oily spotting.

Alli (pronounced “ally” — as in friend or associate) hits drug stores on Friday, June 15. And as its name suggests, Alli is merely one component of a new weight loss program.

More than just a pill, the Alli program involves a reduced-calorie, low-fat diet, regular walking and toning exercises, and behavioral changes. It comes with a companion book called Are You Losing It? Losing Weight Without Losing Your Mind, along with other weight loss material and online support. The drug’s manufacturer, GlaxoSmithKline, is going all out with a splashy marketing plan that includes a museum-style exhibit in Manhattan demonstrating a dieter’s experience before and after the addition of Alli.

The pills cost about $1.50 to $2 a day. A 60-count starter kit retails for $49.25 and a 90-count kit costs $62.99 at www.drugstore.com. GlaxoSmithKline is working with state insurers to get some of the costs covered by insurance.

A Magic Bullet?

If you take Alli and follow a sensible low-fat diet and exercise, you will lose 50 percent more weight than you would with diet and exercise alone. Instead of losing 10 pounds, a person who takes Alli will lose 15 pounds.

“It’s an exciting new tool and widely available, but to think this is the only thing or some magic quick fix is wrong,” says Gary Foster, MD, director of the Center of Obesity Research and Education at Temple University in Philadelphia, who helped develop the Alli program. “For the same amount of effort , you get 50 percent more weight loss. It makes it easier, not effortless,” he tells WebMD.

“Alli is an add-on,” says George Blackburn, MD, PhD, director of the Center for the Study of Nutrition Medicine at the Beth Israel Deaconess Medical Center in Boston. “You have to have a good lifestyle with diet and exercise.”

GlaxoSmithKline even makes the point on its web site devoted to the drug that it “only works if you work” and that it is “not a miracle pill or a quick fix.”

In the recommended Alli diet, one-third of the calories come from fat, one-third come from protein, and the final third comes from carbs.

“Do the things you need to do to lose weight and see if this won’t make it that much more successful,” Blackburn tells WebMD.

“It’s not about a pill, it’s about a program,” agrees Valentine Burroughs, MD, MBA, chief medical officer and chairman of the department of medicine at North General Hospital in New York City. Burroughs participated in developing the Alli program.

How Alli Works

The new drug is not an appetite suppressant. Instead, Alli works by blocking the absorption of fat in the gastrointestinal (GI) tract. But the blocked fat has to go somewhere, which is why many a candid commentator has said not to take Alli on a first date or wear white pants while taking it.

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There are also those planets that were originally spinning, and they have been turned into purple and solidified there, and the picture is extremely strange.

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A weight-loss pill taken by millions of patients in the last two decades has been propped up by problematic clinical studies that “systematically understated” the drug’s potential harms, according to a new analysis. Danish researchers who reviewed data summaries and published journal articles found that seven drug trials funded by the drug maker Roche in the 1990s downplayed the frequency of apparent side effects like diarrhea or incontinence.

The drug, known to scientists as orlistat, and marketed in the US as Alli, has generated hundreds of millions in sales but has slumped in recent years in part because of a reputation for unpleasant gastrointestinal side effects.

The analysis shines light on “something that clinicians often are suspicious of: that the adverse event reporting in clinical trials doesn’t give the whole picture,” said Dr. Raj Padwal, a clinical pharmacologist and internist at the University of Alberta, who was not involved in the analysis.

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The new research, published Tuesday in PLOS Medicine, didn’t examine the data reports that were submitted to the Food and Drug Administration when orlistat was approved, first in 1999 as a prescription drug sold by Roche as Xenical or later as a low-dose, over-the-counter pill sold by GlaxoSmithKline as Alli. (The FDA did, however, review the data from the trials in question.)

Those trials, conducted in the 1990s by researchers at academic or medical centers, resulted in journal articles. To evaluate the thoroughness of these articles, the Danish researchers compared them to data summaries submitted to European regulators, which were obtained by filing Freedom of Information Act requests. They found that the publications disclosed just a fraction — between 14 and 33 percent — of patients’ so-called “adverse events” as compared to the data summaries.

For example, two of the publications left out apparent side effects that occurred in fewer than 5 percent of trial participants; another counted multiple reports from the same patient as just one adverse event.

Another two articles, which are listed currently on Alli’s website as evidence of the drug’s safety and effectiveness, were also problematic. One of them only reported apparent side effects deemed “common”; the other omitted reports of apparent side effects that weren’t at least twice as common among trial participants taking the drug as those taking a placebo.

All of the studies in question still stand in the scientific literature.

Anja von Treskow, a spokeswoman for Roche, said the reporting on the trials “was done according to the standards of the time” and that the company “continuously update our methods” to comply with changing standards.

Joanmarie Goddard, a spokeswoman for Alli’s marketer, GlaxoSmithKline, said the company “take adverse event reporting for our products very seriously and routinely monitor safety information in conjunction with health care professionals and regulatory agencies worldwide.”

The rise and fall of a weight-loss pill

In the first year after Roche brought Xenical to market in the US, the drug brought in $600 million worldwide. Over the course of the 2000s, the drug was prescribed 11 million times in the US, according to an analysis of data from the consumer group Public Citizen. When GSK launched the drug over-the-counter as Alli in 2007, it blew through the gates, selling $155 million in its first weeks on the market.

The drug, which is meant to be paired with diet and exercise, works by preventing the body from absorbing fat. But excreting lots of fat makes the stool oily, leading to gastrointestinal side effects for many patients.

Even at the drug’s peak, warning signs were apparent. US prescriptions of Xenical declined every year. A 2007 study of nearly 17,000 patients found that just 6 percent of participants were still taking Xenical after one year; after two years, it was down to 2 percent.

That’s an indication that “the balance between efficacy and harms is not very beneficial,” said Dr. Jeppe Schroll, lead author of the new analysis and a researcher at the Nordic Cochrane Centre in Copenhagen.

Then in 2010, the FDA added a warning to both Xenical and Alli cautioning about “rare reports” of liver damage; a 2012 study found such alarming toxicity effects that the researcher immediately reported his findings to the FDA.

Roche no longer markets Xenical in the US, though generic versions of the prescription drug are still available. GSK no longer breaks out Alli sales in its financial reports, and wouldn’t comment on current sales figures for the drug. A pack of 120 Alli pills sells online for $56.

In spite of orlistat’s struggles, drug makers aren’t giving up on the pill. A Canadian drug company, M Pharmaceutical, is working on a reformulated alternative that will steer clear of the existing drug’s “socially unacceptable ‘underwear issues.’”

The problem of hidden harms

It’s hard to say how common the harms reporting discrepancies uncovered in the new orlistat analysis are.

The Danish researchers noted that space restrictions in journals may have played a role in what was disclosed, and that data reporting standards that have since been developed might make their findings less applicable to newer drugs.

Dr. Rohan Khera, a cardiology fellow at UT Southwestern Medical Center who has studied the effectiveness of different weight-loss drugs, called the new analysis “a good start in figuring out that there is a need to study this in further detail.”

Dr. Sidney Wolfe, a consumer advocate with Public Citizen who has unsuccessfully petitioned US regulators to take orlistat off the market, believes the stakes are high. “If you’re a doctor and rely on medical journals, you may be misled. Doctors don’t have the time to go reading the actual raw data,” he said.

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