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Drugs & Medical Devices

Hepatitis C Drugs Combined with Antiarrhythmic Drug can Cause Serious Slowing of Heart Rate

— March 27, 2015

Patients treating hepatitis C with Harvoni (ledipasvir/sofosbuvir) or Sovaldi (sofosbuvir) in conjunction with another direct acting antiviral such as the investigational drug daclatasvir or Olysio (simeprevir) and also treating arrhythmia with amiodarone are at serious risk of developing symptomatic bradycardia.

This dangerous combination has already resulted in one patient death due to cardiac arrest and caused three others to require pacemaker placement. Others have recovered after discontinuing one or both drugs. After a review of post-marketing adverse events, the FDA concluded that doctors should refrain from prescribing this potentially lethal combination. The FDA is also adding information about symptomatic bradycardia to Harvoni and Sovaldi labels.

There may be some instances in which other treatment options are not available. In these cases, the FDA suggests that patients be admitted to the hospital for heart monitoring during the first 48 hours of treatment. Following that, daily monitoring in the home or a doctor’s office is needed for the first two weeks of treatment. The drug mechanism responsible for the cases of symptomatic bradycardia hasn’t been identified yet, but is under investigation.

Amiodarone has a long half-life, meaning it remains in the patient’s system even after use has been discontinued. The FDA warns that patients beginning Harvoni or Sovaldi with another direct acting antiviral and who have recently stopped amiodarone undergo cardiac monitoring.

Signs of symptomatic bradycardia include:

  • Near-fainting or fainting
  • Dizziness or light-headedness
  • Malaise
  • Weakness
  • Excessive tiredness
  • Shortness of breath
  • Chest pains
  • Confusion or memory problems

Patients experiencing any of these signs are advised to go to the nearest emergency room due to the potential severity of the drug interaction.

As of this writing, no suits have been filed involving Harvoni and symptomatic bradycardia, though it’s still early. The only suits involving Sovaldi concern that drug’s excessive price tag ($84,000 per treatment course, $1,000 per pill). That suit alleges that this exorbitant price is not necessary to the manufacturer’s patent protection. Gilead Sciences made $8.5B in the first three quarters of 2014 alone.

Depending on how things turn out, Gilead may need to pony up some of those epic profits. Only time will tell.



FDA – Kristen Fischer

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