Gilead Sciences sent a warning letter to healthcare providers on March 20 notifying them of nine patients who had serious reactions after taking a common medication for heart arrhythmias called amiodarone in conjunction with either Harvoni or Sovaldi, the manufacturer’s breakthrough hepatitis C drugs.
Bloomberg reported the breakdown of the medications this group was taking: “The patients were all taking amiodarone, with three also using Harvoni, five receiving Sovaldi with Bristol-Myers Squibb Co.’s daclatasvir and one on Sovaldi with Johnson & Johnson’s Olysio.”
The note disclosed nine patients wound up suffering from symptomatic bradycardia, which is an abnormally low heartbeat. Six cases occurred within 24 hours of a patient taking one of the drugs, and the remainder happened in two to twelve days.
One fatality happened within this group, while another three patients needed to have pacemakers inserted to survive.
Gilead concluded the message admitting “the mechanism of this potential interaction” between therapies is unknown, but advised prescribers to talk to patients about the risk of symptomatic bradycardia.
The company also recommended physicians implement 48 hours of inpatient cardiac monitoring if a patient taking Harvoni, Solvadi, or a similar drug must go on an amiodarone therapy. After this two-day period is completed, the doctor should help the patient transition into an outpatient or self-monitoring setting.
FiercePharma wrote the U.S. Food and Drug Administration (FDA) approved several changes that were made to label warnings of Harvoni and Sovaldi.
Although The Wall Street Journal (WSJ) said investment analysts are assuaging fears that this issue won’t hurt Gilead’s sales, this could become another concern for the corporation.
Doctors Without Borders released a statement last week critiquing a number of provisions Gilead may want to enact overseas for the sales of its pricey drugs.
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Filed Under: Drug Discovery
