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Alli FDA Alerts

The FDA Alert(s) below may be specifically about Alli or relate to a group or class of drugs which include Alli (orlistat).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for orlistat

Alli (60 mg orlistat capsules) by GlaxoSmithKline: Recall - Product Tampering

Mar 28, 2014

Audience: Consumer

ISSUE:  GlaxoSmithKline (GSK) Consumer Healthcare is voluntarily recalling all alli weight loss products from U.S. and Puerto Rico retailers as the company believes that some packages of the product were tampered with and may contain product that is not authentic Alli.

GSK received inquiries from consumers in seven states about bottles of alli that contained tablets and capsules that were not Alli. A range of tablets and capsules of various shapes and colors were reported to be found inside bottles. Additionally, some bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic. These tampered products were purchased in retail stores.

BACKGROUND: Alli is for weight loss in overweight adults, 18 years and older when used along with a reduced-calorie and low fat diet. alli is a turquoise blue capsule with a dark blue band imprinted with the text “60 Orlistat”. It is packaged in a labeled bottle that has an inner foil seal imprinted with the words: “Sealed for Your Protection.”

RECOMMENDATION: Consumers who have product they are unsure or concerned about should not use it. Instead, they should call GSK promptly at 800-671-2554, and a representative will provide further instructions. If they have consumed questionable product, they should also contact their healthcare providers.


[03/28/2014 - Press Release - GlaxoSmithKline]

Orlistat (marketed as Alli and Xenical): Labeling Change

May 26, 2010

Audience: Family Practice healthcare professionals, patients/consumers

FDA notified healthcare professionals and patients that it has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. The agency is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for Alli.

Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat. Xenical (orlistat 120 mg) is available by prescription and Alli (orlistat 60 mg) is sold over-the-counter without a prescription. This new safety information, originally announced in August 2009, is based on FDA's completed review of orlistat.

Healthcare professionals should weigh the benefits of weight-loss with the potential risks associated with Xenical and Alli before prescribing or recommending these medications to their patients; patients should stop use of orlistat and contact their healthcare professional if they develop the signs and symptoms of liver injury, including itching, yellow eyes or skin, dark urine, light-colored stools, or loss of appetite.

[05/26/2010 - Drug Safety Communication - FDA]
[05/26/2010 - Questions and Answers: Orlistat and Severe Liver Injury - FDA]

Alli 60 mg capsules (120 count refill kit): Counterfeit Product

Jan 23, 2010

Audience: Consumers, Pharmacy healthcare professionals

[UPDATE 01/23/2010] FDA updated January 18 alert with information on laboratory analysis of sibutramine levels in counterfeit product.

[Posted 01/18/2010] FDA notified consumers and healthcare professionals about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). The counterfeit version contained the controlled substance sibutramine and did not contain orlistat, the active ingredient. 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. GSK has determined that the counterfeit product has been sold over the internet. However, there is no evidence at this time that the counterfeit Alli product has been sold through other channels, such as retail stores. The differences between the counterfeit and authentic products are described in both text and photos in the FDA news release.

Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].

[01/23/2010] - Updated Public Health Alert - FDA]

[01/18/2010 - News Release With Photos - FDA]

    

Alli 60 mg capsules (120 count refill kit): Counterfeit Product

Jan 18, 2010

Audience: Consumers, Pharmacy healthcare professionals

FDA notified consumers and healthcare professionals about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). The counterfeit version contained the controlled substance sibutramine and did not contain orlistat, the active ingredient. 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. GSK has determined that the counterfeit product has been sold over the internet. However, there is no evidence at this time that the counterfeit Alli product has been sold through other channels, such as retail stores. The differences between the counterfeit and authentic products are described in both text and photos in the FDA news release.

Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].

[01/18/2010 - News Release With Photos - FDA]

    

Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review

Aug 24, 2009

Audience: Endocrinological healthcare professionals, patients

FDA notified healthcare professionals and patients that it is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli. Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA's Adverse Event Reporting System. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice, weakness, and abdominal pain. FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat, analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time. FDA is not advising healthcare professionals to change their prescribing practices with orlistat. Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed.

FDA urges both healthcare professionals and consumers to report side effects from the use of orlistat (Alli and Xenical) to FDA's MedWatch Adverse Event Reporting program.

[08/24/2009 - Early Communication About an Ongoing Safety Review - FDA]

[08/24/2009 - News Release - FDA]

    

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