Sovaldi lawsuits may be emerging soon after the FDA issued a Black Box Warning for the popular direct acting antiviral (DAA) medication. On October, 4, 2016, the FDA issued the strictest warning they have after evidence surfaced that Sovaldi and other DAA medications could cause a reemergence of Hepatitis B in patients. Patients who have taken Sovaldi to treat Hepatitis C, but who have seen a reactivation of their Hepatitis B and subsequently experienced liver damage or liver failure, should contact an experienced Sovaldi lawsuit attorney immediately to review their case.
What is Sovaldi?
Sovaldi is a prescription medication that is used to treat chronic Hepatitis C. Unlike older Hepatitis C medications, Sovaldi provides an essential cure for the deadly disease by preventing HCV from multiplying in a patient’s body. It is often used in combination with other antiviral medications and together they can have a 90% cure rate. Unfortunately, this medication is pricey – costing $1,000 a day for all 12 weeks of treatment. Due to the exorbitant cost, however, most state Medicaid programs cannot afford it and, therefore, must sharply limit access to only the sickest patients. Without this treatment, Hepatitis C cannot be cured and if left untreated will attack the liver, leading to liver failure.
Sovaldi is made by the pharmaceutical giant, Gilead Sciences, and the company has raked in profits from this medication in recent years. Together Sovaldi and Harvoni (another DAA) generated $12.4 billion in sales for Gilead last year alone
Dangers of Sovaldi & Hepatitis B
Now, however, patients have to consider a serious and potentially deadly adverse effect if taking Sovaldi. Patients who have previously been diagnosed with Hepatitis B are at an increased risk for seeing a reactivation of their HBV while undergoing Sovaldi treatment for Hepatitis C. The FDA warns that reactivation usually occurs within 4-8 weeks of treatment. They identified 24 cases of HBV reactivation within a 31-month period. During this time, 2 of those patients died and one required a liver transplant. At the moment, researchers are uncertain as to why Sovaldi would trigger a reactivation of HBV.
The FDA is urging physicians and health care providers to screen all patients for HBV prior to starting their treatment. Any patient with a history of HBV should be monitored closely for signs and symptoms of flare-ups or reactivation during treatment and post treatment follow up. Symptoms of reactivation include vomiting, nausea, yellow skin and eyes, light colored stools, and fatigue.
Sovaldi isn’t the only DAA that received the FDA strict Black Box Warning. Many therapies from multiple drug manufacturers were also covered in the black box warning list, including:
- Harvoni from Gilead Sciences
- Epclusa from Gilead Sciences
- Technivie from AbbVie Inc
- Viekira Pak & Viekira Pak XR from AbbVie Inc
- Daklinza from Bristol-Myers Squibb
- Xepatier from Merck Sharp Dohme
- And Olysio from Johnson & Johnson & Janssen
What is Hepatitis C?
Hepatitis C is a contagious liver disease that is transmittable through direct contact with contaminated blood. What usually starts as Acute Hepatitis C virus, however, quickly turns in to chronic Hepatitis C infections in up to 85% of patients. It is estimated by the CDC that up to 3.9 million people in the United States suffer from Chronic Hepatitis C.
The Hepatitis C virus is transmitted through infected blood, either through a blood transfusion, infected needles, needle sticks in the healthcare setting, or a baby born to a mother with Hepatitis C. If left untreated, Hepatitis C can turn deadly, causing liver failure and liver.
If you suffered a recurrence of Hepatitis B as a result of taking a Hepatitis C medication, such as such as Sovaldi, Harvoni, or Viekira Pak, you may be eligible for financial compensation. To learn more about Sovaldi Lawsuits and to discover if you or your loved one may be eligible, contact us immediately. For a free case evaluation, please complete the form on this page or call us today.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.