| ALLI | FDA | 2010-5-26 | ALLI-FDA-2010-5-26 | 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.
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| ALLI | MHRA | 2010-1-25 | ALLI-MHRA-2010-1-25 | The Medicines and Healthcare products Regulatory Agency (MHRA) is warning consumers of the dangers of buying medicines from unregulated websites after the discovery in the United States of counterfeit Alli, a weight loss drug.
The Food and Drug Administration (FDA) in the US has been working with pharmaceutical manufacturer GlaxoSmithKline (GSK) following the report of counterfeit Alli, which although has not been found in the United Kingdom, is still potentially available to UK customers via the internet.
Laboratory testing of the suspected counterfeit product, 60mg Alli capsules (120 capsule refill kit), revealed it contained sibutramine instead of orlistat.
The licence for sibutramine was recommended for suspension across Europe last week by the European Medicines Agency (EMA) following evidence to suggest an increased risk of non-fatal heart attacks and strokes.
"The trend of self-diagnosing and self-prescribing is potentially dangerous, but unless the website has a physical address clearly displayed, and the green cross logo of the Royal Pharmaceutical Society of Great Britain (RPSGB) then the likelihood of obtaining a counterfeit product is greatly increased.
"Buying weight loss medication from unregulated websites is a dangerous way to slim down.
We encourage everyone --the public and healthcare professionals as well as the industry -- to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.
The Royal Pharmaceutical Society of Great Britain (RPSGB) has introduced an internet pharmacy logo to help the public identify if a website is being operated by a bona fide pharmacy in Great Britain.
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| ALLI | FDA | 2009-8-24 | ALLI-FDA-2009-8-24 | 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�(TM)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.
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