Jeffrey Salazar
Alli is a popular over-the-counter weight loss drug that has been linked to rare instances of acute liver injury, with some cases resulting in liver transplants or even death. The U.S. Food and Drug Administration (FDA) has received reports of liver injury among users of Alli, with some studies suggesting that the drug's active ingredient, orlistat, may cause 'severe toxicity to major internal organs, including the liver. While the FDA has issued warnings and updated safety labels, there are concerns about the drug's continued availability and the potential risks it poses to consumers.
| Characteristics | Values |
|---|---|
| Alli's active ingredient | Orlistat |
| Orlistat's function | Inhibits the digestion of dietary fats and prevents their absorption, thus reducing caloric intake |
| Orlistat's side effects | Abdominal discomfort, bloating, gaseousness, diarrhea, fecal leakage, steatorrhea (oily stools and fat-soluble vitamin malabsorption) |
| Orlistat's systemic side effects | None expected |
| Orlistat's approval for use in the US | 1999 |
| Over-the-counter approval | 2007 |
| Orlistat's reported cases of severe liver injury | 13 total reports (12 foreign reports with Xenical and 1 US report with Alli) |
| Potential side effects of liver injury | Itching, yellow eyes or skin, dark urine, loss of appetite, light-colored stools, anorexia, pruritus, jaundice, right upper quadrant pain |
| FDA's action on potential liver damage | Revised label for Xenical to include new safety information about cases of severe liver injury |
| FDA's stance on diet pills | Considered safe until found otherwise |
| Alli's sales performance | Over $130 million in sales during its first year |
| Manufacturer of Alli | GlaxoSmithKlineBeecham |
| GlaxoSmithKline's stance on liver damage risk | Refuted |
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What You'll Learn
- Orlistat, the active ingredient in Alli, has been linked to rare instances of acute liver injury
- A 2010 FDA review identified 13 total reports of severe liver injury with orlistat; 12 foreign reports with Xenical and 1 U.S. report with Alli
- Symptoms of liver injury include itching, yellow eyes or skin, dark urine, loss of appetite, or light-coloured stools
- The FDA has received 32 reports of liver injury among orlistat users, including 27 cases that resulted in hospitalisation
- According to a University of Rhode Island study, orlistat can cause severe toxicity to major internal organs
Orlistat, the active ingredient in Alli, has been linked to rare instances of acute liver injury
It is important to note that confirming a cause-and-effect relationship between orlistat and severe liver injury is challenging. Some patients in the reported cases also used other drugs or had underlying conditions that may have contributed to the development of liver injury. Additionally, severe liver injury can occur in individuals who are not taking any medications and without a distinct cause. While the mechanism by which orlistat causes liver injury is not fully understood, it is hypothesized that hypersensitivity may play a role due to the low absorption rate of orlistat.
Symptoms of potential liver injury include itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. If you experience any of these symptoms while taking Alli, it is crucial to discontinue the medication immediately and consult a healthcare professional. They may advise liver function tests and monitor ALT and AST levels to assess liver health.
Despite the reports of liver injury, Alli remains a popular weight loss supplement that has been approved by the FDA. The decision to include information about potential liver injury in the drug label for Xenical and Alli is based on a comprehensive review of all available data. However, it is worth noting that liver damage is a severe condition that can lead to inflammation, necrosis, vascular lesions, and possible liver failure. Therefore, it is essential to carefully consider the benefits and risks of using Alli for weight loss and consult a healthcare professional if you have any concerns.
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A 2010 FDA review identified 13 total reports of severe liver injury with orlistat; 12 foreign reports with Xenical and 1 U.S. report with Alli
Orlistat is a weight-loss agent that is available both by prescription and over-the-counter. The prescription brand name for orlistat is Xenical, while the over-the-counter name is Alli. Orlistat has been linked to rare instances of acute liver injury, some of which have been severe.
In 2010, the FDA reviewed 13 total reports of severe liver injury associated with the use of orlistat-containing medicines. Twelve of these reports were foreign cases involving Xenical, and one was a US case involving Alli. This review was based on an analysis of all available data from preclinical and clinical trials, post-marketing studies, and drug utilization from April 1999 through August 7, 2009. It is important to note that the FDA has stated that a causal relationship between orlistat use and severe liver injury has not been established. However, due to the seriousness of severe liver injury, the FDA has added information about reported cases to the labels of both Xenical and Alli.
The mechanism by which orlistat causes liver injury is not yet known. However, it is hypothesized that because only small amounts of orlistat are absorbed, hypersensitivity may be the mechanism by which the liver is damaged. Typical hypersensitivity features have not been prominent in case reports, however.
If liver injury is suspected, orlistat therapy should be discontinued immediately, and liver function tests should be conducted. Patients taking orlistat should be instructed to report any symptoms of hepatic dysfunction, such as anorexia, pruritus, jaundice, dark urine, light-colored stools, or right upper quadrant pain.
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Symptoms of liver injury include itching, yellow eyes or skin, dark urine, loss of appetite, or light-coloured stools
Alli is a popular weight-loss supplement that has been approved by the FDA. However, it has been investigated by the FDA for its potential to cause liver damage. Orlistat, the weight-loss ingredient in Alli, has been linked to rare instances of acute liver injury, some of which have been severe. According to the FDA, there have been a small number of reports of severe liver damage associated with the use of Alli.
The mechanism by which orlistat causes liver injury is not yet fully understood. However, it is believed that orlistat inhibits the function of a key enzyme called carboxylesterase-2, which plays a crucial role in detoxifying the liver, kidneys, and gastrointestinal tract. This inhibition may result in severe toxicity to internal organs, including the liver.
While the cause-and-effect relationship between orlistat and severe liver injury has not been established, it is important to weigh the benefits of weight loss against the potential risks associated with Alli and similar medications. Patients should be made aware of these risks and closely monitored for any signs or symptoms of liver dysfunction. If liver injury is suspected, orlistat and other suspect medications should be discontinued immediately, and appropriate medical care should be sought.
It is worth noting that some individuals who have taken Alli have shared their experiences online, reporting side effects such as fatigue, listlessness, diarrhoea, and, in one case, a severe rash that cleared up after discontinuing the use of Alli. These anecdotes underscore the potential risks associated with the use of weight-loss drugs and the importance of careful consideration and medical supervision when using such products.
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The FDA has received 32 reports of liver injury among orlistat users, including 27 cases that resulted in hospitalisation
Orlistat, the active ingredient in the weight loss drug Alli, has been linked to rare instances of acute liver injury, some of which have been severe. In May 2010, the FDA announced a new consumer warning for Xenical/Alli, indicating the potential for liver toxicity. This was based on a review that identified 13 total reports of severe liver injury with orlistat: 12 foreign reports with Xenical and 1 U.S. report with Alli.
In 2021, the FDA announced that they were investigating reports of liver damage linked to Alli and Xenical. The FDA had received 32 reports of liver injury among users of orlistat-based weight loss drugs, including 27 cases that resulted in hospitalisation. This is a significant increase from the 13 cases reported in 2010, indicating a growing concern about the potential side effects of orlistat.
While the exact mechanism by which orlistat causes liver injury is not known, it is believed that hypersensitivity may play a role. Some patients in the reported cases also used other drugs or had other conditions that may have contributed to the development of severe liver injury. It is important to note that severe liver injury can occur in people who are not taking any drugs and without a distinct cause. At this time, a cause-and-effect relationship between orlistat use and severe liver injury has not been established.
Individuals taking Alli or Xenical should be aware of the potential side effects and contact their healthcare professional if they experience any symptoms of liver injury, such as itching, yellow eyes or skin, dark urine, loss of appetite, or light-coloured stools. If liver injury is suspected, orlistat and other suspect medications should be discontinued immediately, and liver function tests should be performed.
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According to a University of Rhode Island study, orlistat can cause severe toxicity to major internal organs
Orlistat, sold under the brand names Xenical and Alli, is a weight-loss drug that works by inhibiting the absorption of fat in the body. It is available by prescription and over the counter.
According to a University of Rhode Island study, orlistat can cause "severe toxicity" to major internal organs, including the liver and kidneys. The study, led by pharmacology professor Bingfan Yan, found that the drug inhibits the function of carboxylesterase-2, a key enzyme responsible for detoxifying the liver, kidneys, and gastrointestinal tract. This inhibition is irreversible and can occur even at low doses of the drug.
The FDA has acknowledged rare reports of severe liver injury associated with orlistat use, although a cause-and-effect relationship has not been established. In response to these reports, the FDA approved a revised label for Xenical and Alli to include a warning about the rare risk of severe liver injury.
In addition to liver toxicity, orlistat has been linked to other adverse effects, including gastrointestinal issues such as oily stools, diarrhoea, abdominal pain, and fecal incontinence. It can also decrease the absorption of certain vitamins and nutrients, and interfere with the effectiveness of other medications, including life-saving cancer treatments.
Given the potential risks, it is important for individuals considering orlistat to consult with their healthcare provider and carefully weigh the benefits against the potential side effects.
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Frequently asked questions
Alli is a popular weight loss supplement that has been approved by the FDA. It is available over the counter and is the lower-dose version of the prescription drug Xenical.
There have been several reports of liver damage in people using Alli. The FDA has received 32 reports of liver injury among users of Alli and Xenical, with 27 cases resulting in hospitalization. However, the cause-and-effect relationship between Alli and liver damage has not been established.
Signs of liver injury include itching, yellow eyes or skin, dark urine, loss of appetite, or light-coloured stools. If you experience any of these symptoms while taking Alli, you should contact your healthcare professional immediately.
If liver injury is suspected, Alli and other suspect medications should be discontinued immediately. Liver function tests and ALT and AST levels should be obtained to assess liver health.
