The FDA has announced a safety review involving the weight loss medication, orlistat. There have been reports of liver damage in 32 patients, six of which have lead to liver failure. Most of these cases have occurred outside the United States.
Xenical and Alli
Orlistat was initially released to the market in 1999 as the prescription weight loss medication, Xenical. It is dosed as 120 mg three times daily with meals that contain fat. Orlistat is a fat-blocker and can prevent absorbtion of 30% of fat from the diet. Patients are advised to eat meals that contain less than 30% fat in the total meal to prevent side effects.
Alli was released in 2007 as an over-the-counter medication. The dose is 60 mg three times daily, half the strength of Xenical.
Who Should Use Orlistat
Orlistat is recommended for use in patients who are considered to be clinically obese. This means a BMI (body mass index) of 30 or more. Overweight people with diabetes, high blood pressure or other cardiac risk factors are also appropriate for orlistat. As Alli, orlistat is not recommended for use in patients under the age of 18. Studies with Xenical were conducted in children ages 12 to 16. Xenical is considered safe to use in these kids, but was not studied in children under the age of 12.
Effectiveness of Orlistat
Patients taking orlistat and watching their diet can expect to lose approximately 13 pounds within the first three months. This weight loss does not usually increase with up to one year of treatment. Weight loss was roughly double that of patients following the diet alone. Most dieters began losing weight within two weeks of starting treatment with orlistat. The medication also helps patients maintain weight loss for at least one year.
Xenical was found to be helpful for weight loss in patients with diabetes. Many of these patients were also able to decrease the doses of their diabetes medications. Xenical was also useful in preventing diabetes in patients with prediabetes. It also helped lower cholesterol levels.
Side Effects of Orlistat
No reports of liver damage were included in the initial studies. The most common side effects of orlistat are gastrointestinal. Patients report greasy, oily stools, excess gas and trouble controlling bowel movements. This worsens when eating a diet or meal that contains more than 30% of calories from fat. Most patients experienced these problems within the first week of treatment, but noticed improvement with continued use.
Because orlistat blocks fat absorbtion, it also may decrease the amount of fat-soluble vitamins that are absorbed. Vitamins that are a concern include vitamin A, vitamin D, vitamin E and beta carotene. Patients taking orlistat are advised to also take a multivitamin. The vitamin should be taken at bedtime so that orlistat is less likely to interfere with absorbtion.
Signs of Liver Damage
Many medications have the potential to damage the liver because they are broken-down there before leaving the body. Symptoms of liver damage may include:
- jaundice
- weakness
- abdominal pain
- fatigue
- fever
- brown urine
- loss of appetite
- nausea
- vomiting
- itching
- light-colored stools
The FDA has not yet established a definite link between orlistat and the reports of liver damage in the patients that were taking it. Until more information is known, patients taking orlistat who are experiencing these symptoms should discontinue the medication and contact their healthcare provider immediately.
Melissa Murfin - Melissa is a physician assistant in endocrinology with a further specialization in thyroid and parathyroid disorders. She is also a ...
