On April 14, 2011, Public Citizen (citizen.org) issued a petition, urging the US Food and Drug Administration (FDA) to remove Alli and Xenical (a stronger, prescription formula of orlistat) from the market. The petition was sent because of the potential for "significant damage to multiple critical organs," Sidney Wolfe, Public Citizen Director, said in a news release.
Among the reported damage was a potential risk of severe liver injury, including two deaths linked to liver failure and three liver transplants. A further reported side effect was an increased risk of pancreatitis. According to Public Citizen, the FDA's MedWatch adverse reaction reports contained 47 cases of pancreatitis linked to Xenical or Alli. Of those, 39 patients were hospitalized and one died. Finally, Public Citizen reported 73 cases of kidney stones including 23 hospitalizations and three cases of acute kidney failure including one death.
To some people, those may not seem like a huge risk; after all, the risk of heart problems, diabetes and other weight-associated complications are also quite high. But according to Public Citizen, orlistat products are not much more effective than diet and exercise alone in helping people lose weight. According to the news release, people who took Alli for four months lost fewer than five pounds more than people who used diet and exercise to lose weight. Meanwhile, patients who took orlistat 60-mg doses for one year with diet and exercise lost only 5.6 pounds more than people who used diet and exercise without medication.
READ MORE ALLI ORLISTAT LIVER DAMAGE LEGAL NEWS
In May 2010, the FDA announced a revised label for Xenical to include warnings about the risk of severe liver injury associated with the medication. Patients are urged to be on the lookout for any signs of liver injury, including jaundice, dark urine or right upper quadrant pain, when taking orlistat.
Xenical, the 120-mg orlistat medication was approved as a prescription medication by the FDA in 1999 for obesity management, according to the FDA. Alli was approved in 2007 as an over-the-counter weight loss product. An August 24, 2009 communication from the FDA noted that many of the adverse reports associated with Alli and Xenical originated outside of the US. So far, the FDA has not announced a recall of either medication.