There have always been some serious concerns over weight loss products. Are they effective? Are they actually healthy? What exactly are the health risks? You canâ€™t turn on the television without rarely having a set of commercials that goes by without a weight loss product being advertised. And, there are 2 more products currently under fire.
In an April 14, 2011 article found on citizen.org, there is a cry for 2 more weight loss products to be removed from the shelves. There has actually been a petition filed with the FDA to have Alli and Xenical removed from the market immediately because they not only can damage the liver, but also, based on new information obtained from FDA adverse reaction files, have been associated with 47 cases of acute pancreatitis and 73 cases of kidney stones.
Both drugs are forms of orlistat, and Public Citizen, a national, nonprofit consumer advocacy organization based in Washington, D.C. says, that their serious risks greatly outweigh their benefits, which are questionable, because neither has been shown to be much more effective than diet and exercise.
â€œAny one of these serious risks alone would be sufficient basis for banning Xenical and Alli,â€ said Dr. Sidney Wolfe, director of Public Citizenâ€™s Health Research Group. â€œThese drugs have the potential to cause significant damage to multiple critical organs, yet they provide meager benefits in reducing weight loss in obese and overweight patients. For this reason, the FDA should tell the manufacturers of these drugs, Hoffman-LaRoche and GlaxoSmithKline, to pull Xenical and Alli, respectively, from the market immediately.â€
But this is not the first attempt to remove these products from consumers reach. In 2006, Public Citizen filed a petition against Xenical, and it was rejected from the FDA.
Although this second petition does address the effectiveness of these products, itâ€™s primary concern is that the drugs are dangerous. Public Citizen believes the biggest problem with the drugs is their potential to cause serious injuries and death.
The article states that in May 2010, the FDA issued a warning about â€œsevere liver injuryâ€ resulting from using orlistat, which is found in both Xenical and Alli. The FDA identified 12 foreign reports of severe liver toxicity associated with Xenical and one domestic case for Alli. Two of the patients actually died of liver failure and three required liver transplants.
Another serious adverse effect of taking Xenical or Alli is acute pancreatitis, which may be especially difficult to diagnose since orlistatâ€™s most common side effects, including abdominal pain and nausea, are also typically symptoms of pancreatitis. Public Citizenâ€™s research of FDA MedWatch adverse reaction reports found 47 cases of pancreatitis associated with Xenical or Alli. Thirty-nine of those patients required hospitalization and one died.
Public Citizenâ€™s analysis of FDAâ€™s MedWatch reports also identified 73 cases of kidney stones associated with Xenical or Alli use, of which 23 required hospitalization. In a review of the medical literature, Public Citizen also identified at least three patients taking orlistat who developed acute kidney failure because tiny calcium salt crystals formed throughout the kidneys. In one reported case, the patient required dialysis and ultimately died.
Although not as many physicians are writing prescriptions for Xenical, and not as many consumers are purchasing the over the counter Alli, Public Citizen still believes that too many people are still being placed in harmâ€™s way. The petition is calling for immediate action. How many more people will unknowingly be affected by these drugs before the FDA takes this seriously? Letâ€™s hope not many. Letâ€™s hope they respond to this second attempt at banning and removing these drugs from the weight loss market.