Sold by drug giant GlaxoSmithKline (GSK), Alliwas 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 under its Alli brand 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.
To view the list on FDA’s website, click here.
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.”
The health signal comes just over a month after a leading national weight loss dietary supplement brand was recalled in the US due to liver damage.
On May 1, 14 different products in the Hydroxycut line, which sold over nine million units in 2008 alone, were voluntarily recalled by their manufacturer Iovate Health Sciences after 23 adverse event reports recorded instances of serious liver damage, as well as one death.
The recall prompted a flood of attacks on the supplements industry in the mainstream press, which still continue today. Amongst other accusations, the one recurring criticism is that supplements are not properly regulated in the US.
Indeed, the anti-obesity group Reality Coalition was amongst the first to call for a review of the Dietary Supplement Health and Education Act (DSHEA). The Reality Coalition was set up in 2006, supported by a grant from GSK.
Alli vs Supplements
The battle for market share between Alli and supplement weight loss products took a sharp turn in April last year, when a petition filed by GSK sought to wipe out supplements from the weight loss category.
Filed together with the American Dietetic Association, The Obesity Society and Shaping America's Health, the citizen petition requested that all weight loss claims be considered disease claims. This would effectively prevent dietary supplement products from claiming they can promote, assist or otherwise help in weight loss.
However, although the petition generated heated industry debate at the time, FDA has made no response as yet, and most supplement players feel the issue has been buried and forgotten in a mount of legislative bureaucracy.