FDA: Zofran 32-mg dose pulled from market

December 6, 2012
FDA: zofran 32-mg dose pulled from market
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 , as the 32-mg dose makes up a very small percentage of the current market."

Explore further: FDA announces new limits on high-dose simvastatin (Zocor)

More information: More Information

Related Stories

FDA announces new limits on high-dose simvastatin (Zocor)

June 9, 2011
The United States Food and Drug Administration (FDA) today announced new limitations to the use of high-dose simvastatin, due to the increased risk of muscle pain and weakness (myopathy) and in rare cases, kidney damage and ...

FDA adds more warnings to antidepressant's label

March 28, 2012
(HealthDay) -- In a follow-up to a warning that high doses of the popular antidepressant Celexa can cause potentially fatal abnormal heart rhythms, the U.S. Food and Drug Administration has issued new dosing and use recommendations.

FDA issues multiple sclerosis drug alert

May 14, 2012
(HealthDay) -- The multiple sclerosis drug Gilenya (fingolimod) should not be given to patients with certain pre-existing or recent heart conditions or stroke, or those taking certain medications to correct heart rhythm problems, ...

Experts challenge FDA over approval for new dose of Alzheimer's drug

March 22, 2012
Approval for a new dose of a best-selling Alzheimer's drug "breached the FDA's own regulatory standard" and has led to "incomplete and distorted messages" about the drug, warn experts in the British Medical Journal today.

Recommended for you

Cancer drugs' high prices not justified by cost of development, study contends

September 12, 2017
(HealthDay)— Excusing the sky-high price tags of many new cancer treatments, pharmaceutical companies often blame high research and development (R&D) costs.

Non-psychotropic cannabinoids show promise for pain relief

September 4, 2017
Some cancers love bone. They thrive in its nutrient-rich environment while gnawing away at the very substrate that sustains them, all the while releasing inflammatory substances that cause pain—pain so severe that opioids ...

Fentanyl drives rise in opioid-linked deaths in U.S.

August 31, 2017
(HealthDay)—Fentanyl, a synthetic narcotic, is a key player in America's continuing epidemic of opioid-related overdose deaths, two new studies report.

Eating triggers endorphin release in the brain

August 28, 2017
Finnish researchers have revealed how eating stimulates brain's endogenous opioid system to signal pleasure and satiety.

Cholesterol-lowering drugs may fight infectious disease

August 21, 2017
That statin you've been taking to lower your risk of heart attack or stroke may one day pull double duty, providing protection against a whole host of infectious diseases, including typhoid fever, chlamydia, and malaria.

Data revealed under FOI shows benefits of multiple sclerosis drug currently blocked by regulators

August 17, 2017
A drug that is blocked by the EU regulatory system has now been found to improve the quality of life of people with multiple sclerosis (MS), according to a study by Queen Mary University of London (QMUL).

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.