Research shows the antiemetic drug ondansetron hydrochloride—sold under the brand name Zofran—might cause a potentially fatal irregular heart rhythm, called “QT prolongation,” because of abnormal electrical activity in the heartbeat.
What Is Zofran and What Is It Prescribed For?
Zofran is the brand name for the drug ondansetron hydrochloride. Made and sold by British pharmaceutical company GlaxoSmithKline plc, this prescription medication is used to treat nausea associated with chemotherapy, radiation therapy, and surgery. The U.S. Food and Drug Administration (FDA) first approved it in 1992, and doctors prescribe it three forms: an injectable, an oral solution, and in oral tablets containing 4 mg to 24 mg Zofran.
A member of the “selective 5-HT3 receptor antagonist” class of drugs, Zofran interacts with a subtype of serotonin receptor in the vagus nerve, which supplies information to the brain on the function of internal organs. Although scientists aren’t sure of the drug’s precise mechanism of action, they believe Zofran inhibits serotonin from bonding with the 5-HT3 receptor, which in turn prevents vomiting and reduces nausea.
Zofran Might Cause Heart-Related Side Effects
In September 2011 the FDA released a Zofran warning in the form of a Drug Safety Communication informing the public that the drug can prolong the “QT interval,” a segment of the human heartbeat as defined in terms of electrical impulses. This “QT interval prolongation” can indicate a type of irregular heartbeat called “Torsades de Pointes,” and it is a risk factor for sudden death. Although Zofran’s label already included a QT prolongation warning, the FDA determined that these side effects affect those who are already suffering from heart problems such as:
- Congenital long QT syndrome;
- Predisposition to low levels of potassium and magnesium in the blood;
- Taking other medications that lead to QT prolongation;
- Electrolyte abnormalities (hypokalemia or hypomagnesemia);
- Congestive heart failure; and
- Bradyarrhythmias (slow heartbeats).
The FDA asked GlaxoSmithKline to further study Zofran’s effects on QT intervals, and it will require the manufacturer to update the drug’s label to inform the public of its belief in the increased risk.
In June 2012, the FDA advised against using the 32 mg intravenous version of Zofran in another Drug Safety Communication. However, on December 4, 2012, the FDA announced that this version of Zofran would be removed from the market due to its potential to cause QT interval prolongation.
RLG’s Zofran Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Zofran lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Zofran lawsuit on your behalf if necessary. RLG will also keep you up to date on any Zofran class action lawsuits, FDA Zofran warnings, and Zofran FDA recall announcements. If you have taken Zofran and believe it harmed you, contact RLG today.