healthcare professionals
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Questions
Answers
Is alli being reviewed by the Food and Drug Administration (FDA)?
The FDA regularly reviews all prescription and non-prescription drugs it has approved for risks and side effects. GSK has worked closely with the FDA since the approval of alli by providing data from reports from our consumers or their healthcare professionals. We will continue to do so as part of our postmarketing surveillance for alli. back to top Why is the FDA conducting a review of alli in relation to hepatotoxicity?
As part of the FDA’s and GSK’s ongoing postmarketing surveillance of alli, there have been a small number of reported liver-related adverse events out of the nearly six million people who have taken alli since over-the-counter (OTC) availability. Most of these reports have been mild and have not provided evidence for clinical concern; none have been causally linked to alli. Liver changes (specifically elevation in liver function tests) can have many causes. Importantly, people who are overweight and obese are predisposed to liver-related disorders. We encourage patients to speak with their physicians if they have any concerns. back to top If the FDA includes a product on its DAART list, doesn’t that mean there’s a problem?
No. The appearance of a drug on the DAART list does not mean that the FDA has concluded that a risk or causal relationship exists. It may reflect a potential issue for which the Agency seeks further evaluation and continued monitoring.
Analysis of data contained within the AERS database is part of the FDA’s standard pharmacovigilance processes to continue to monitor products after approval. back to top Does alli cause liver toxicity?
There is no evidence that alli causes liver injury. As part of the FDA’s and GSK’s ongoing post-marketing surveillance of alli, there have been only a small number of reported liver-related adverse effects out of the nearly 6 million people who have taken alli since it became available OTC – none have shown that alli causes liver injury. Clinical studies have not shown any difference in liver-related changes compared to placebo.1 back to top Is alli safe?
alli is the only OTC FDA-approved weight loss drug. The safety and efficacy of orlistat is well established. In the higher dose, orlistat has been marketed as the prescription drug Xenical since 1999, and is supported by nine years of worldwide use in 145 other countries. Orlistat experience in more than 30 million patient treatments and more than 100 clinical studies with more than 30,000 patients is unprecedented in the weight loss category.2 back to top Should alli patients be concerned about potential liver injury?
alli works only in the digestive system, where it prevents about 25% of dietary fat consumed from being absorbed; it does not work systemically.
- alli does not act on the brain3
- alli does not speed up metabolism3
- alli does not raise blood pressure3
- alli will not cause sleeplessness or a racing heart3
There is therefore no obvious biological mechanism to suggest liver injury can occur with alli. back to top What else can cause liver toxicity?
Liver changes, specifically elevation in liver function tests, can have many causes:
- People who are overweight and obese are predisposed to liver-related disorders4,5
- Liver-related adverse events are more likely to represent concurrent disease
back to top How does GSK monitor adverse effects among alli users?
The safety of patients is of utmost importance to GSK and we take a proactive and holistic approach to adverse effects signal detection and evaluation. This includes regular review of emerging safety data from multiple sources including clinical studies and postmarketing case reports from both consumers and health care professionals.
All signals are evaluated; however, priority is given for serious events, and events that if found to be causally related to the drug could significantly affect the benefit-risk profile. back to top Is alli / orlistat safe?
Orlistat is the most comprehensively studied weight loss medication and has been used by nearly six million people since OTC availability. Its safety and efficacy have been well established through data from more than 100 clinical studies involving more than 30,000 patients. In one study alone, over 3,000 people were followed for four years while taking 120 mg orlistat. In all, more than 30 million people have used orlistat in more than 145 countries. back to top Where can I go for more information?
If you would like further information, our call center will be able to take your call and forward it to an appropriate member of our medical team. back to top
References
- Roche Xenical NDA 20-766. Submitted November 1996. Approved April 1999.
- Chanoine J-P. Data presented at the European Congress on Obesity, Geneva, May 2008, during the symposium “Obesity a short history in time” (Roche).
- Anderson J. Orlistat for the management of overweight individuals and obesity: a review of potential for the 60 mg, over-the-counter dosage. Expert Opinion on Pharmacotherapy. 2007; 8(11): 1733 – 1742.
- Kaplan LM. Leptin, obesity, and liver disease. Gastroenterology 1998; 115: 997-1001.
- Scheen AJ and Luyckx FH. Obesity and liver disease. Best Practice & Research Clinical Endocrinology and Metabolism 2002; 16(4): 703-716.
- Drug-induced liver toxicity page. Food and Drug Administration Web site. Available at: http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ucm071471.htm. Accessed September 1, 2009.
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