Cancer News
OncoLink Cancer News - HealthDay


FDA: Zofran 32-mg Dose Pulled From Market

Wednesday, December 5, 2012 (Last Updated: 12/06/2012)

WEDNESDAY, Dec. 5 (HealthDay News) -- The 32-mg, single intravenous dose of Zofran (ondansetron), an anti-nausea drug, is being removed from the market due to its potential to cause serious, even fatal, cardiac damage, according to a Drug Safety Communication (DSC) issued Dec. 4 by the U.S. Food and Drug Administration.

The agency issued a prior DSC in late June 2012 recommending that this particular dose of Zofran be avoided due to the risk of prolonged QT interval, which can lead to torsades de pointes, a potentially fatal heart rhythm.

The FDA does continue to recommend Zofran administered intravenously at 0.15 mg/kg every four hours for patients experiencing chemotherapy-related nausea and vomiting, with no single dose exceeding 16 mg. The agency is working with manufacturers of all branded and generic 32-mg intravenous ondansetron injectable products to recall them from the market and anticipates the product will be removed through early 2013.

According to a press release issued by the agency, the FDA "does not anticipate that removal of the 32-mg intravenous dose of ondansetron currently sold as pre-mixed injections will contribute to a drug shortage of intravenous ondansetron, as the 32-mg dose makes up a very small percentage of the current market."

More Information

Specialties Gastroenterology
Family Practice
Hematology & Oncology
Nursing
Pathology
Surgery

Copyright © 2012 HealthDay. All rights reserved.


I Wish You Knew

Pain management in cancer care - are patients getting what they need?

View More



Blogs and Web Chats

OncoLink Blogs give our readers a chance to react to and comment on key cancer news topics and provides a forum for OncoLink Experts and readers to share opinions and learn from each other.




OncoLink OncoPilot

Facing a new cancer diagnosis or changing the course of your current treatment? Let our cancer nurses help you through!

Learn More