My Alli FDA Information

My Alli is a weight loss program that includes the over-the-counter drug Alli, meal planning, portion sizes, recipes and exercise. The program focuses on making healthy food choices, lowering calories and fats and increasing fiber. Alli is an FDA approved over-the-counter drug with an excellent safety record, although there are unpleasant side effects and potential health concerns. Consult your doctor about taking Alli and pursuing a weight loss program to improve your health.

FDA Regulatory Power

Under the 1938 Food, Drugs and Cosmetics Act and amendments in 1962, the FDA has the authority to regulate therapeutic claims on drugs, oversee clinical trials and review the results to determine safety and efficacy of the drug. This authority includes approving content in product labels for both prescription and non-prescription drugs. The FDA also has the power to regulate manufacturing and post-market safety issues of drugs to protect the public from any dangers with respect to the products.

FDA Approved Indication

The FDA approved Alli in 2007 as a non-prescription weight loss drug to be used in conjunction with a reduced-calorie and low fat diet in overweight adults, 18 years and older. Alli is the first approved over-the-counter weight loss product in its category of lipase inhibitors. Orlistat is the active ingredient in Alli, the same ingredient that is in Xenical, a prescription drug the FDA approved in 1999 to treat obesity in conjunction with a reduced caloric diet, and to reduce the risk of regaining weight after prior weight loss. Alli contains 60 mg of orlistat, a substance that prevents absorption of 25 percent of fat from foods, reduces the amount of calories that enter your body and can induce a loss of 5 to 10 percent of your weight over time.

FDA Approved Safety and Efficacy

Alli is safe and effective when used as directed. Prior to FDA approval for Xenical, scientists studied the safety and effectiveness of orlistat in over 100 clinical trials comprised of over 30,000 patients. The FDA reviewed the results from these studies and authorized the information in the product label. According to 2010 information supplied by the FDA, over 40 million people have used orlistat since 1999 when it was approved as a prescription drug; this number includes over 10 million people worldwide that have used Alli since it was first marketed in 2007. Nonetheless, Alli has side effects that include gas, oily stools and sudden bowel movements. Despite these uncomfortable side effects, clinical studies demonstrate Alli can help you lose 50 percent more weight than diet alone, according to manufacturer GlaxoSmithKline.

FDA Post Marketing Announcements

The FDA protects the public by reporting periodically safety related issues related to drugs. The FDA reported in 2009 that 32 patients taking orlistat experienced serious liver injury and 27 of these patients were hospitalized with diagnosed with liver failure. Stomach pain, weakness and jaundice, a condition of yellowing of your skin and eyes, are some of the symptoms associated with these adverse effects. Consult your physician if you experience these symptoms.