FDA Warns Direct-Acting Antiviral (DAA) Medications For Hepatitis C Virus May Risk Hepatitis B Reactivating


Patients Being Treated With Direct-Acting Antiviral Drugs For Infection Of Hepatitis B Virus And Hepatitis C Virus Are At Risk For Liver Transplant Or Death.

liver-damage-hepatitis-b-reactivating-orders-boxed-warningThe U.S. Food and Drug Administration (FDA) issued a warning about the risk of hepatitis B virus (HBV) becoming active again in patients being treated with certain direct-acting antiviral (DAA) medications for hepatitis C virus. As a result, the federal regulatory agency is requiring the labels of certain direct-acting antiviral (DAA) medications to contain a boxed warning, the FDA’s most serious and prominent warning, about the risk of HBV reactivating. The FDA also wants manufacturers of certain direct-acting antiviral (DAA) medication drugs to include the warning in the patient information leaflet or Medication Guides.
[fda.gov/Drugs/DrugSafety/ucm522932.htm, FDA, October 4, 2016]

DAA medications requiring new warnings

The DAA medications requiring new warnings by the FDA and their manufacturers are:

  • Daklinza (daclatasvir), Bristol-Myers Squibb
  • Epclusa (sofosbuvir and velpatasvir), Gilead Sciences
  • Harvoni (ledipasvir and sofosbuvir), Gilead Sciences
  • Olysio (simeprevir), Janssen
  • Sovaldi (sofosbuvir), Gilead Sciences
  • Technivie (ombitasvir and paritaprevir and ritonavir), Abbvie
  • Viekira Pak (dasabuvir and ombitasvir and paritaprevir and ritonavir), Abbvie
  • Viekira Pak XR (dasabuvir and ombitasvir and paritaprevir and ritonavir), Abbvie
  • Zepatier (elbasvir and grazoprevir), Merck Sharp Dohme

[fda.gov/Drugs/DrugSafety/ucm522932.htm, FDA, October 4, 2016]

“It’s important for patients to follow the FDA’s recommendation of letting their health care providers know if they have a history of hepatitis B infection or other liver problems before they’re treated for hepatitis C virus,” says Dr. Francois Blaudeau, founder of Southern Med Law who is also a practicing physician.

What is a Direct-acting antiviral (DAA) medication?

Direct-acting antiviral (DAA) medication is used to treat chronic hepatitis C virus (HCV) infection by reducing the amount of HCV in the body and preventing HCV from multiplying, according to the FDA. DAA medicines, in most cases, cure HCV. Without treatment, HCV can lead to serious liver problems including cirrhosis, liver cancer, and death.

24 cases of HBV reactivation reported due to Direct-acting antiviral (DAA) medication

The FDA identified 24 cases of HBV reactivation reported to the agency and from HCV/HBV co-infected patients treated with DAAs from November 22, 2013 to July 16, 2016. Of the 24 cases reported, two patients died and one required a liver transplant. According to the agency, HBV reactivation was not reported as an adverse event in the clinical trials submitted for the DAA approvals because patients with HBV co-infection were excluded from the trials. These patients were not included in the trials since the trials specifically evaluated the safety of DAAs in patients infected with only HCV and without the presence of another virus which affects the liver. The 24 cases reported only include cases submitted to the FDA, so there are “likely additional cases about which we are unaware,” the agency said in its safety communication.
[fda.gov/Drugs/DrugSafety/ucm522932.htm, FDA, October 4, 2016]

Southern Med Law fighting for safer drugs

Dr. Francois Blaudeau and Southern Med Law attorneys are knowledgeable about issues patients face with direct-acting antiviral (DAA) medication and represent clients in dangerous drug lawsuits, including Zofran (In Re: Zofran Birth Defects Lawsuit Litigation – MDL No. 2657) and Xarelto. (In Re: Xarelto Products Liability Litigation, Xarelto Bleeding Lawsuit Case No. 2592) If you or a loved one experienced life-threatening injuries other complications allegedly associated with Direct-Acting Antiviral medications, or medications such as Zofran or Xarelto, contact the Firm to learn more about your legal rights and to arrange for a free, no obligation direct-acting antiviral (DAA) medication lawsuit review by calling Southern Med Law today, at 205-547-5525 or visit www.southernmedlaw.com for more information and to fill out a contact form.

About Southern Med Law And Filing A Direct-Acting Antiviral Medication Lawsuit

Throughout his career, Dr. Francois Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made the Southern Med Law team an aggressive and effective attorney and advocate for those who were harmed due to negligent pharmaceutical companies. If you or a loved one believe they where harmed by Direct-Acting Antiviral medications, contact Southern Med Law today to learn more about your legal rights. Call today for a free, no obligation Direct-Acting Antiviral medication lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.

Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Fax: 205-547-5526

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