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Home> Industry Information> State Food and Drug Administration Revises Orlistat Preparation and Stabilizes Hypnotic Drugs Specification

State Food and Drug Administration Revises Orlistat Preparation and Stabilizes Hypnotic Drugs Specification

July 07, 2021

State Food and Drug Administration Revises Orlistat Preparation and Stabilizes Hypnotic Drugs Specification


In the newly revised Orlistat formulation [Adverse Reactions] section, it was updated to “Use of Orlistat has reported rare elevations of transaminases, elevated alkaline phosphatase, and severe hepatitis, and liver failure has occurred. Some of these patients need liver transplantation or can directly lead to death.Orlistat also reported rare allergic reactions, the main clinical manifestations of itching, rash, urticaria, angioneurotic edema, bronchial spasm and allergic reaction, The appearance of large herpes is rare. Post-marketing surveillance has also revealed reports of pancreatitis." [Notes], updated to "Due to rare acute liver cell necrosis or severe liver failure caused by orlistat marketing Injuries report that some of these cases require liver transplantation or can directly lead to death. Therefore, the prescribing doctor should instruct the patient to actively report any symptoms and signs of liver dysfunction after taking orlistat (such as loss of appetite, itching, jaundice, and dark urine , stool color light, upper right quadrant pain. When any of the aforementioned symptoms, orlistat should be immediately disabled and other Drug suspect, and liver function tests. "

Orlistat 1

Orlistat is a non central nervous system obesity drug. It only acts on the gastrointestinal tract, prevents the hydrolysis of triglyceride to free fatty acids and monoacylglycerides by inhibiting the lipase in the gastrointestinal tract, reduces the absorption of dietary fat (triglyceride) by intestinal mucosa, and promotes the elimination of fat from the body. Lipase is an essential enzyme for the gastrointestinal tract to decompose fat. This product can combine with serine residues of gastric and pancreatic lipases to inactivate lipase, prevent it from decomposing fat in food into free fatty acids, inhibit the utilization and absorption of fat. In addition, this product can also reduce the risk factors related to obesity.


In the newly revised "adverse reactions" section of the "stable" hypnotic drug prescription, anaphylactic shock (severe allergic reaction) and angioedema (severe facial edema) may be increased at the beginning of the first administration of this product. Taking this product may cause behaviors of sleep syndrome, including the contents of potentially dangerous behaviors such as driving, sleepwalking, cooking and eating.


Orlistat has been given long-term treatment for obese and overweight people with moderate diet control and exercise, including those who have developed obesity related risk factors.

Orlistat 2

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