FDA: Zofran 32-mg dose pulled from market
December 6, 2012 in Medications
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 issued Dec. 4 by the U.S. Food and Drug Administration.
(HealthDay)—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: More Information
Copyright © 2012 HealthDay. All rights reserved.
-
FDA announces new limits on high-dose simvastatin (Zocor)
Jun 09, 2011 |
not rated yet |
0
-
FDA adds more warnings to antidepressant's label
Mar 28, 2012 |
not rated yet |
0
-
Ondansetron reduces vomiting, hospital admissions in children with gastroenteritis
Sep 02, 2008 |
not rated yet |
0
-
FDA issues multiple sclerosis drug alert
May 14, 2012 |
not rated yet |
0
-
FDA acts against unapproved colchicine
Feb 06, 2008 |
not rated yet |
0
-
Motion perception revisited: High Phi effect challenges established motion perception assumptions
Apr 23, 2013 |
3 / 5 (2) |
2
-
Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update)
Apr 02, 2013 |
4.5 / 5 (11) |
5
-
The visual system as economist: Neural resource allocation in visual adaptation
Mar 30, 2013 |
5 / 5 (2) |
9
-
Separate lives: Neuronal and organismal lifespans decoupled
Mar 27, 2013 |
4.9 / 5 (8) |
0
-
Sizing things up: The evolutionary neurobiology of scale invariance
Feb 28, 2013 |
4.8 / 5 (10) |
14
-
Why is zone 1 in liver more prone to ischemic injury?
May 23, 2013
-
How can there be villous adenoma in colon, if there are no villi there
May 22, 2013
-
How can there be a term called "intestinal metaplasia" of stomach
May 21, 2013
-
Pressure-volume curve: Elastic Recoil Pressure don't make sense
May 18, 2013
-
If you became brain-dead, would you want them to pull the plug?
May 17, 2013
-
MRI bill question
May 15, 2013
- More from Physics Forums - Medical Sciences
More news stories
Merck ends development of Parkinson's disease drug
(AP)—Merck & Co. says it is ending development of an experimental Parkinson's disease drug because the drug wasn't working.
Medications
23 hours ago |
1 / 5 (1) |
0
J&J expects 10-plus new drug applications by 2017
(AP)—Johnson & Johnson is developing what could eventually be game-changing treatments for depression and pain, and it's aiming to apply for approval of more than 10 new medicines by 2017, executives said Thursday during ...
Medications
May 23, 2013 |
5 / 5 (1) |
0
Experts favor US approval of Merck sleeping pill (Update)
An independent panel of experts on Wednesday recommended US approval of a new Merck sleeping pill called suvorexant, but expressed concerns over the highest dosage and risks of drowsy daytime driving.
Medications
May 22, 2013 |
not rated yet |
0
Glaxo, US partnering to develop new antibiotics
GlaxoSmithKline PLC says it's starting an unusual collaboration with the U.S. government to develop several antibiotics for both bioterrorism threats and bacterial infections resistant to current medicines.
Medications
May 22, 2013 |
not rated yet |
0
Study finds new pneumococcal vaccine appears to be as safe as previously used vaccine
The new 13-valent pneumococcal conjugate vaccine (PCV13) appears to be as safe as the previous version used prior to 2010, the 7-valent pneumococcal conjugate vaccine (PCV7), according to a Kaiser Permanente study published ...
Medications
May 22, 2013 |
not rated yet |
0
Engineered cytomegalovirus protects monkeys from HIV equivalent
(Medical Xpress)—A new study by researchers in the US has shown that an ancient virus can be modified to help in the fight against the simian immunodeficiency virus SIV, which is the equivalent in monkeys ...
Researchers identify first drug targets in childhood genetic tumor disorder
Two mutations central to the development of infantile myofibromatosis (IM)—a disorder characterized by multiple tumors involving the skin, bone, and soft tissue—may provide new therapeutic targets, according to researchers ...
Hormone levels may provide key to understanding psychological disorders in women
Women at a particular stage in their monthly menstrual cycle may be more vulnerable to some of the psychological side-effects associated with stressful experiences, according to a study from UCL.
Going live: Immune cell activation in multiple sclerosis
Biological processes are generally based on events at the molecular and cellular level. To understand what happens in the course of infections, diseases or normal bodily functions, scientists would need to ...
Driving and hands-free talking lead to spike in errors, study shows
Talking on a hands-free device while behind the wheel can lead to a sharp increase in errors that could imperil other drivers on the road, according to new research from the University of Alberta.
Controlling mood through the motions of mitochondria
(Medical Xpress)—Regulating the distribution of power in neurons is done by a system that makes the national electric grid look simple by comparison. Each neuron has several thousand mitochondria confined ...
