Sold by drug giant GlaxoSmithKline (GSK), Alli was approved as
the only non-prescription weight loss drug in 2007, bringing it into direct competition with the dietary supplement weight loss category.
FDA yesterday updated drug surveillance information on its website, which lists all products that are identified as potentially harmful. Amongst the new products added to the list was orlistat, a weight loss drug sold by GSK’s under its Allibrand and by Roche as the prescription product Xenical.
The potential risk was identified via an adverse event reporting system for drugs, which highlighted possible liver problems (hepatotoxicity) linked to the products.
FDA says that the addition of a drug to this surveillance list does not mean that a causal relationship between the drug and the listed risk has been identified. “It means that FDA has identified a potential safety issue.”
“FDA is continuing to evaluate this issue to determine the need for any regulatory action,” states the agency.
GSK told NutraIngredients-USA.com that the reporting of adverse events for Alli was standard procedure.
“Very few adverse events have been reported, which is significant when you consider that more than six million people have used Alli since we launched [it] in 2007,” said a company spokesperson.
“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) are common and can have many causes.”
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