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.
In June this year, NutraIngredients-USA.com reported that FDA had added orlistat to its drug surveillance list, which includes all products identified as potentially harmful. Orlistat is the drug contained in Alli, as well as in Xenical, the prescription weight-loss product sold by Roche.
Suspected liver injury
The agency yesterday said it is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury in its examination of adverse event reports.
The issue has also been discussed at the FDA’s Center for Drug Evaluation and Research Drug Safety Oversight Board, it said.
“The issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services,” said Steven Osborne, M.D., executive director of the Board.
The potential risk was identified via an adverse event reporting system for drugs, which highlighted possible liver problems (hepatotoxicity) linked to the products.
FDA said it received 32 reports of serious liver injury in people taking orlistat between 1999 and 2008. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States.
The most commonly reported adverse events included jaundice, weakness and stomach pain.
FDA said its analysis of the drugs is “ongoing” and advises consumers to continue taking the products. “No definite association between liver injury and orlistat has been established at this time,” it said.
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.
Hydroxycut
The supplement weight loss category also received a massive hit earlier this year, when top-selling brand Hydroxycut was linked to liver damage by an adverse event reporting system.
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.