The FDA issued a warning that hepatitis C treatment Viekira Pak and Technivie can cause serious side effects and serious liver injury, mostly in patients with underlying advanced liver disease.
The drugs in question belong to AbbVie (ABBV) with some of their ingredients made by Enanta (ENTA), both were subjected to selloffs after the news, in addition to Express Script (ESRX) Holding, which operates as a pharmacy benefit management (PBM) in the United States and Canada stock, which lost over 4% of its value. Express the pharmacy management firm that decided to reimburse for these drugs only, rejecting Gilead’s drugs.
The same news instigated a rally in Gilead’s (GILD) stock price.
The FDA Requirement: FDA required the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Post-marketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.
According to the FDA, 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, at least 26 worldwide cases 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. The FDA believes that there are likely additional cases about which FDA is unaware.
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.
The FDA Recommendation: The FDA recommended that 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.
The agency recommended that 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program
No Comment Except that all the FDA requirements and recommendations be followed by all the parties mentioned by the FDA. Abiding by the FDA requirements and recommendation will protect from unwarranted life-threatening adverse effects that would have been avoided if all the parties would have followed the FDA guidelines that were issued following these drugs’ approvals especially those related to contraindications, interactions and observance of early symptoms as being described by the FDA.
Pharmacies must hand a list of all the interacting drugs with each and every package sold.
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