| FDA Issues Early Communication about Ongoing | | | | no definite association between liver injury and |
| Safety Review of Weight Loss Drug Orlistat - | | | | orlistat has been established at this time. Consumers |
| Review includes the prescription drugs Xenical, Orlistat | | | | taking Xenical should continue to take it as |
| and OTC drug Alli | | | | prescribed, and those using over-the-counter Alli |
| FDA NEWS RELEASE | | | | should continue to use the product as directed. |
| For Immediate Release: Aug. 24, 2009 | | | | The Early Communication is a risk communication tool |
| The U.S. Food and Drug Administration announced | | | | used by the FDA to inform the public about its |
| today that it is reviewing adverse event reports of | | | | ongoing safety reviews of drugs. The FDA will |
| liver injury in patients taking the weight loss drug | | | | release its findings on orlistat as soon as the review |
| orlistat, marketed as the prescription drug Xenical and | | | | is completed. |
| the over-the-counter medication Alli. | | | | Consumers who have used orlistat should consult a |
| Between 1999 and 2008, the FDA received 32 | | | | health care professional if they experience symptoms |
| reports of serious liver injury in patients taking | | | | possibly associated with development of liver injury, |
| orlistat. Of those cases, 27 reported hospitalization | | | | particularly weakness or fatigue, fever, jaundice, or |
| and six resulted in liver failure. Thirty of the adverse | | | | brown urine. Other symptoms may include abdominal |
| events occurred outside the United States. The most | | | | pain, nausea, vomiting, light-colored stools, itching, or |
| commonly reported adverse events included | | | | loss of appetite. |
| yellowing of the skin or whites of the eyes | | | | >>>>End of News Release from |
| (jaundice), weakness, and stomach pain. | | | | FDA<<<<< |
| The FDA is reviewing additional data submitted by | | | | BEFORE PURCHASING ALTERNATIVE SUPPLEMENTS |
| orlistat manufacturers on suspected cases of liver | | | | TO XENICAL, ALLI AND ORLISTAT, dieters may |
| injury, and the issue has been discussed at the | | | | want to review the FREE information available at |
| FDA’s Center for Drug Evaluation and Research | | | | Manage Weight Loss Review. |
| Drug Safety Oversight Board. | | | | There has also been a great deal of interest in what |
| “The issues here are complex, but FDA has | | | | is know as the Hoodia Diet. Dieters may want to |
| benefited from the input of the Board, including | | | | review the FREE information on this diet supplement |
| comments from representatives from three FDA | | | | and associated programs at The Hoodia Diet Review. |
| Centers and several other Agencies in the | | | | See the links below for access to these two FREE |
| Department of Health and Human Services,” said | | | | resources |
| Steven Osborne, M.D., executive director of the | | | | As always, DO NOT begin taking ANY diet |
| Board. | | | | supplement or begin a diet and weight loss program |
| The FDA’s analysis of these data is ongoing, and | | | | with first consulting your medical professional. |