Alli

Blog entry

A New Year's Resolution

The start of a new year. It is even the start of a new decade. For some, it can be a new beginning. Looking back, it is hard to believe that another year has gone by so fast. Many will remember all of the talk about Y2K, but now we are looking at 2K10. It is a new start for many and a time for New Year’s resolutions. This is a time to pause and reflect on the changes that we want to make and resolve to follow through on a new beginning.More »

Alli, encouragement, hope, Meridia, New Year's Resolutions, weight loss

News Story

FDA Revises Orlistat Labeling to Warn of Rare Cases of Severe Liver Injury

05/26/2010

The U.S. Food and Drug Administration is advising consumers and health care professionals about potential rare occurrences of severe liver injury in patients taking the weight-loss medication orlistat, marketed as Xenical and Alli.

The FDA has approved a revised label for the prescription drug Xenical. The agency is working with the manufacturer of Alli on label revisions to reflect this rare occurrence.

Both Xenical and Alli are medications containing the same active ingredient, orlistat. Xenical, available only by prescription, contains 120 milligrams of orlistat. Alli, sold over-the-counter without a prescription, contains 60 mg of orlistat. An estimated 40 million people worldwide have taken either Xenical or Alli.

The FDA’s safety information and labeling changes are based on a review of cases of severe liver injury reported in individuals taking orlistat. The agency has identified 13 cases of severe liver injury, 12 of which were reports from outside of the United States. The only U.S. report of severe liver injury involved Alli. At this time, a cause-and-effect relationship of severe liver injury with orlistat use has not been established.

People who take Xenical or Alli should be aware that liver injury with orlistat – while rare – has been reported. Those taking the drug also should be aware of the signs and symptoms of liver injury, which include itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools.More »

Alli, FDA, Orlistat

Online Auction Sites Selling Fake Weight Loss Products

01/25/2010

GlaxoSmithKline Consumer Healthcare alerts consumers today that a small quantity of fake weight loss product, falsely packaged and labeled as alli® has been sold on online auction websites, such as eBay. The FDA has reassured consumers that "there is no evidence at this time that counterfeit alli products has been sold through other channels, such as retail stores." Consumers can have confidence buying alli only from reputable retailers or from their branded online websites. When purchased from these reputable retailers, consumers can have confidence the product is genuine and they should continue use.

The falsely packaged and labeled products are the 60mg, 120ct refill packs only. The products are sold on online auction sites directly to consumers and are falsely represented as the genuine alli product.

Preliminary testing confirms that the counterfeit products do not contain the active ingredient orlistat, which is found in the authentic alli product. The prescription drug sibutramine has been detected in the fake product. Sibutramine is the active ingredient in the prescription drug, Meridia. Sibutramine could potentially interact with other medications the consumer may be taking and there are dosing differences between alli (three times a day) and Meridia (once a day).More »

Alli, counterfeit drugs, Merida

FDA Warns Consumers about Counterfeit Alli

01/19/2010

The U.S. Food and Drug Administration is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).

Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.More »

Alli, FDA Alert.
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