The Food and Drug Administration (FDA) has updated the labels on some hepatitis C drugs.
The agency is issuing warnings surrounding the risk of hepatitis B coming back for some patients who have suffered from the disease before. The move also applies to some of the newer and most expensive hepatitis C medications.
The FDA said the decision will include black-box warnings in the labels of at least nine Hepatitis C brand-name direct-acting antiviral drugs, such as Sovaldi and Harvoni from Gilead Sciences, Inc. (NASDAQ:GILD).
Other medications that will get the label — which is the most serious warning that the agency can give out — include Viekira Pak from AbbVie (NYSE:ABBV) and Zepatier from Merck & Co., Inc. (NYSE:MRK).One such medication is prescribed to patients who need a liver transplant. Most of these drugs treat conditions that may be easily treatable at first, but later result in other symptoms that need to be addressed.”This number includes only cases submitted to the FDA, so there are likely additional cases about which we are unaware,” the FDA said on its website. More than 3 million people in the U.S. are afflicted with Hepatitis C–some of these patients only need to be treated with drugs that affect one’s blood flow, while others need an actual organ transplant to survive in the long run.
