Other safety alerts
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| The United States: Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone |
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The US Food and Drug Administration (FDA) is warning that serious slowing of the heart rate 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. FDA is adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the Harvoni and Sovaldi labels. FDA is recommending that health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct acting antiviral, such as the investigational drug daclatasvir or Olysio (simeprevir), with amiodarone.
FDA review of submitted postmarketing adverse event reports found that patients can develop a serious and life-threatening symptomatic bradycardia when either Harvoni or Sovaldi combined with another direct-acting antiviral is taken together with amiodarone. The reports included the death of one patient due to cardiac arrest and three patients requiring placement of a pacemaker to regulate their heart rhythms. The other patients recovered after discontinuing either the hepatitis C drugs or amiodarone, or both. The cause of these events could not be determined. FDA 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.
Health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone. However, in cases where alternative treatment options are unavailable, FDA recommends heart monitoring in an inpatient hospital setting for the first 48 hours. Subsequently, monitoring in a doctor’s office or self-monitoring of the heart rate should be done every day through at least the first 2 weeks of treatment.
Due to the long half-life of amiodarone, patients discontinuing amiodarone just prior to starting Harvoni, or Sovaldi in combination with another direct-acting antiviral, should also undergo similar cardiac monitoring as outlined above.
Patients taking either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone should seek medical attention right away if they experience signs or symptoms of symptomatic bradycardia
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm439662.htm
In Hong Kong, Harvoni is not a registered pharmaceutical product. Meanwhile, there is one registered pharmaceutical product containing sofosbuvir, namely Sovaldi Tablets 400mg (HK-63501). It is a prescription only medicine registered by Gilead Sciences Hong Kong Limited. The company has informed the Department of Health (DH) that they have issued letters to inform local healthcare professionals on the new warnings, and will apply to include the new warnings in the local product information. So far, the DH has received 2 adverse drug reaction reports on Sovaldi Tablets, and none of them was associated with symptomatic bradycardia adverse events. In view of the FDA's announcement, letters to healthcare professionals will be issued to draw their attention to the issue, and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, March 25, 2015
Issued at HKT 16:30
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