Direct-Acting Antivirals Require Warning on Labelling
October 4, 2016 - The U.S. FDA released a communications requiring a boxed warning to be added to the labeling and Medication Guides of direct-acting antiviral (DAA) drugs, which are used to treat chronic hepatitis C. The Safety Communication warned that hepatitis B may return or worsen for patients who take a DAA while they have or did have hepatitis B. Between late November 2013 and mid-July 2016, FDA documented over 20 cases of hepatitis B that was reactivated by a DAA. Three of the cases were severe – resulting in a liver transplant or death. Before starting treatment for hepatitis C, patients should let their doctors know if they also have or had hepatitis B. Additionally, patients taking a DAA should immediately report symptoms, such as extreme fatigue, light-colored stools, loss of appetite, nausea, vomiting and yellowed eyes or skin, that could indicate liver damage from reactivated hepatitis B. Healthcare providers are advised to test hepatitis C patients for hepatitis B, as well. All DAAs will carry the new warning. The direct acting antiviral drugs currently approved in the United States, are Daklinza™ (daclatasvir), Epclusa® (sofosbuvir/velpatasvir), Harvoni® (sofosbuvir/ledipasvir), Olysio® (simeprevir), Technivie® (ombitasvir/paritaprevir/ritonavir), Viekira® Pak and Viekira XR™ (dasabuvir/ombitasvir/paritaprevir/ ritonavir) and Zepatier™ (elbasvir/grazoprevir).
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.