其 他 安 全 警 示
|
| |
| The United States: FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease (English only) |
| |
The US Food and Drug Administration (FDA) announces that it has received reports that the use of Mavyret (a fixed-dose combination of glecaprevir and pibrentasvir), Zepatier (a fixed-dose combination of elbasvir and grazoprevir), or Vosevi (a fixed-dose combination of sofosbuvir, velpatasvir, and voxilaprevir) to treat chronic hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. All these medicines contain a hepatitis C virus (HCV) protease inhibitor and are not indicated for use in patients with moderate to severe liver impairment. In most patients, symptoms resolved or new onset worsening of liver function improved after stopping the medicine. These medicines have been widely used and are safe and effective in patients with no or mild liver impairment.
In many of the reported cases, liver failure occurred in patients who had signs and symptoms of moderate to severe liver impairment (Child-Pugh B or C) or other serious liver problems and should not have been treated with these medicines. In some cases, patients were reported to have no cirrhosis or compensated cirrhosis with mild liver impairment (Child-Pugh A) despite having evidence of decreased platelets at baseline or an increase in the pressure within the portal vein that carries blood from the digestive organs to the liver. In addition, some cases had other significant pre-existing risk factors such as liver cancer, alcohol abuse, or serious medical illnesses associated with serious liver problems. These factors may have contributed to clinical worsening of liver function or liver failure during treatment with these hepatitis C medicines. In most cases, liver failure or decompensation typically occurred within the first 4 weeks of starting treatment. FDA will continue to monitor this safety concern and will communicate any new information to the public if it becomes available.
Health care professionals should continue to prescribe Mavyret, Zepatier, or Vosevi as indicated in the prescribing information for patients without liver impairment or with mild liver impairment (Child-Pugh A). Assess severity of liver disease at baseline and closely monitor for signs and symptoms of worsening liver function such as increases in liver enzymes, jaundice, ascites, encephalopathy, and variceal hemorrhage. Assessment of baseline liver disease and close monitoring are especially important in those with pre-existing significant liver problems or risk factors, such as hepatocellular carcinoma or alcohol abuse, which can also contribute to clinical worsening of liver function or liver failure during treatment. Discontinue these medicines in patients who develop signs and symptoms of liver decompensation or as clinically indicated.
Patients should be aware that the risk of serious liver injury is rare. However, they should contact their health care professional right away if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools as these may be signs of liver injury. If they have liver impairment or other pre-existing risk factors that can worsen liver function such as a history of alcohol abuse, they should talk with their health care professional about the benefits and risks of the medicine.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrence-serious-liver-injury-use-hepatitis-c-medicines-mavyret-zepatier-and
In Hong Kong, Maviret Tablets (HK-65653) is registered by Abbvie Limited, Zepatier Tablets (HK-65571) is registered by Merck Sharp & Dohme (Asia) Ltd, and Vosevi Tablets (HK-65775) is registered by Gilead Sciences Hong Kong Limited. All products are prescription-only medicines. So far, the Department of Health (DH) has received 5 cases of adverse drug reaction related to glecaprevir/pibrentasvir, of which one case is related to alanine aminotransferase increased and hyperbilirubinaemia. In light of the above FDA’s announcement, letters to inform local healthcare professionals will be issued. The DH will continue to remain vigilant on safety update of the drugs issued by FDA and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Thursday, Aug 29, 2019
Issued at HKT 16:00
|
| |
|
