Sunday, March 30, 2014

Topic: Anti-Nausea Migraine Medication Zofran Issued New FDA Warning

Anti-Nausea Migraine Medication Zofran Issued New FDA Warning

Last month the Food & Drug Administration (FDA) announced a new warning for anti-nausea medication Zofran.

Zofran is FDA approved for treatment of cancer-related nausea (such as nausea related to chemo or radiation treatments), but is also often prescribed for nausea experienced by migraine patients and pregnant women.

In the September 2011 warning the FDA said Zofran can cause deadly changes to patients’ heart rhythms. They said the people at greatest risk of experiencing the drug’s potential side effects are those who have existing heart problems.

Zofran belongs to a class of drugs called 5-HT3 receptor antagonists. It works by blocking the actions of serotonin. The generic version of Zofran is called Ondansetron.

The FDA has ordered GlaxoSmithKline, the manufacturer of Zofran, to conduct studies to determine how severe the problem could be and who is at greatest risk. Pending those findings the FDA has ordered a change to the product label stating the risk and recommends electrocardiogram (ECG) monitoring for patients thought to be at the most risk for complications.

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