- FDA Safety Review of Orlistat - Xenical and Alli - Image from Food and Drug Administration (FDA)
Following an orlistat safety review, on May 26 2010 the US Food and Drug Administration (FDA) announced that it has approved an upgrade to the diet pill’s label to include new information about the risk for severe liver damage that has been reported with orlistat’s use. The FDA reviewed risk of liver side effects for both prescription Xenical (orlistat 120mg) and over-the-counter (OTC) Alli (orlistat 60mg).
FDA Safety Review for Risk of Liver Side Effects of Orlistat (OTC Alli, Xenical)
In August 2009, the FDA announced via an 'Early Communication' notice that the regulatory authority was undertaking a safety review of orlistat-containing products, due to a number of possible liver-related side effects that had been reported for the weight loss drug since its availability in 1999.
At the time, the FDA notified the public that from 1999 to October 2008, the regulatory body had received 32 reports of serious liver injury in people taking orlistat, which included six cases of liver failure. The most commonly reported liver-related adverse events were jaundice, weakness, and abdominal pain, with hospitalization required for 27 of the 32 cases.
At this stage the FDA had not established whether there was a definitive link between the liver damage seen and the usage of orlistat. The FDA therefore went on to review all the available safety data regarding possible liver-related side effects for prescription orlistat (Xenical) from preclinical trials, clinical trials, drug-utilization and post-marketing studies until August 2009, as well as post-marketing safety data for OTC orlistat (Alli) through to October 2008.
What did the FDA Safety Review for Xenical and OTC Alli Find?
On May 26 2010, the FDA announced that as a result of the orlistat safety review, the agency had identified 12 cases of severe liver injury that were reported during postmarketing studies for Xenical and one case that was associated with the use of OTC Alli. As yet, however, a “cause-and-effect” relationship between the liver adverse events and orlistat usage still has not been established.
The FDA noted that among the 13 cases identified, there may have been other factors or pharmaceutical drugs that may have contributed to the severe liver damage which orlistat-users developed. The agency noted that it is very difficult to confirm a 'cause-and-effect' relationship between the weight loss drug orlistat and liver damage, due to a total of 40 million people around the world using Xenical or Alli with many taking other medications. In addition, among the 13 identified cases, some orlistat users suffered from other conditions at the same time, which may have contributed to the development of the liver damage seen.
The FDA also noted that among the 13 cases of severe liver damage identified, two patients died as a result of liver failure and three patients required liver transplantation.
Label Upgrade for Orlistat Diet Pills, Xenical and Alli
As a result of the FDA safety review, additional safety information with regard to the increased risk for liver-associated side effects will be added to both Xenical and OTC Alli. This will aim to inform healthcare professionals and users about the symptoms of liver damage and what they should do if they notice such warning signs – symptoms of liver damage may include anorexia, pruritus, jaundice, dark urine, light colored stools, or right upper quadrant pain.
The FDA recommends that if any symptoms of liver damage are observed in orlistat users, the patient should consult their doctor and undergo liver function tests if liver damage is suspected. In addition, any suspected adverse events associated with Alli or Xenical use should be reported to the FDA via their MedWatch program.
Readers may also be interested in the following articles:
SIbutramine Ban Will Influence New Obesity Drugs
Hope on the Horizon with New Obesity Treatments
Sources:
FDA 2009, ‘Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)’, 24 August 2009
FDA 2010, ‘FDA Drug Safety Communication: Completed safety review of Xenical/Alli (orlistat) and severe liver injury’, 26 May 2010
FDA 2010, ‘Questions and Answers: Orlistat and Severe Liver Injury’, 26 May 2010
Christine Redmond - My interest in science and healthcare has seen me working in the laboratory with tiny cells and DNA to helping set up a cancer clinical ...
