ADR that result in revision of patient information
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| The United States: Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of serious liver injury |
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FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.
Viekira Pak and Technivie are used to treat chronic hepatitis C. Viekira Pak is a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir used with or without ribavirin, another hepatitis C medicine. Technivie is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir, used in combination with ribavirin.
FDA review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to the manufacturer of these medicines, AbbVie, identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines. Some of these events resulted in liver transplantation or death. These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it.
Since the approvals of Viekira Pak in December 2014 and Technivie in July 2015 in the US, at least 26 worldwide cases submitted to FAERS were considered to be possibly or probably related to Viekira Pak or Technivie. In most of the cases, liver injury occurred within 1 to 4 weeks of starting treatment. Some of the cases occurred in patients for whom these medicines were contraindicated or not recommended. FAERS includes only reports submitted to FDA, so there are likely additional cases about which FDA is unaware.
Health care professionals should closely monitor for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in direct bilirubin in the blood.
Patients taking these medicines should contact their health care professional immediately 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. Patients should not stop taking these medicines without first talking to their health care professionals. Stopping treatment early could result in drug resistance to other hepatitis C medicines.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm468757.htm
In Hong Kong, Viekira Pak Tablets (HK-63695) is a pharmaceutical product registered by Abbvie Limited (Abbvie), and is a prescription-only medicine; while Technivie is not registered. So far, the Department of Health has received four cases of adverse drug reaction after taking Viekira Pak, and none of them was related to liver injury. As confirmed with Abbvie, the company is going to apply for update of package insert of the product to include the relevant information. In view of the US FDA's announcement, letters to inform local healthcare professionals of the warning will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Friday, October 23, 2015
Issued at HKT 15:00
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