FDA Issues Warning of Life-Threatening Effect When Combining A Heart Drug with New Hepatitis C Drugs

The US Food and Drug Administration (FDA) issued a warning about the risk of potentially life-threatening slowing of the heart rate that can occur when a common heart drug is taken with new hepatitis C medications.

The agency said that this complication can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. The FDA said that it is updating the labels for Harvoni and Sovaldi to include information about the serious slowing of the heart rate, known as symptomatic bradycardia.

Harvoni and Sovaldi are two new drugs that were recently approved by the agency to help rid the body of hepatitis C, which, if left untreated, can damage the liver and raise the odds of liver failure and liver cancer.

The safety risk was found by the FDA during review of submitted postmarketing adverse event reports. The reports included the death of one patient due to cardiac arrest and three patients requiring replacement of a pacemaker to regulate their heart rhythms. The other patients recovered after discontinuing treatment with either the hepatitis C drugs or amiodarone, or both.

The FDA said that the cause of these events could not be determined, but that it will continue to monitor Harvoni and Sovaldi for risks of serious symptomatic bradycardia and further investigate the reason why the use of amiodarone with these hepatitis C drugs led to the heart-related events.

The agency is telling physicians not to prescribe Harvoni or Sovaldi combined with another direct-acting antiviral to patients taking amiodarone. However, in cases where physicians have no choice but to prescribe either Harvoni or Sovaldi in combination with another direct-acting antiviral drug for patients taking the heart drug, patients should be monitored in hospitals for the first 48 hours. Subsequently, monitoring in a physician’s office or self-monitoring of the heart rate should be done every day for the first two weeks of treatment.

Source: US Food and Drug Administration

Last updated: 3/26/15; 11:30am EST

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