GlaxoSmithKline lowers dosage to protect your heart
  • Thu, 07/05/2012 - 9:33am

GlaxoSmithKline LLC has lowered Zofran’s dosage label after preliminary results of a clinical study revealed a risk of developing an abnormal heart rhythm. The anti-nausea medication is commonly administered to chemotherapy or radiation patients, according to Drugs.com.

Last Friday, the U.S. Food and Drug Administration reported that GlaxoSmithKline LLC removed the 32 mg single intravenous dose from Zofran’s label because the dose impacted the heart’s electrical activity. Preliminary results of the clinical study suggested that the alteration of the heart’s electrical activity could cause some patients to develop a type of abnormal heart rhythm called Torsades de Pointes, which can be fatal.

The FDA’s website also noted that the new label will allow continued use of Zofran at a dose of 0.15 mg/kg every four hours for three doses in adults and children with nausea and vomiting as a result of receiving chemotherapy. The label will warn against administering any single dose greater than 16 mg.

The FDA  says that it will review the final study results and cooperate with GlaxoSmithKline to find safer and more effective single dose regiments for patients suffering nausea and vomiting as a result of chemotherapy.

According to MedicineNet, chemotherapy uses drugs to prevent or decrease the fast growth and division of cancer cells in cancer patients. Nausea and vomiting are common side effects of chemotherapy because the treatment can also target healthy cells that line the intestines.

Abnormal heart rhythms, according to MedicineNet, can occur in the atrium (chambers located on both sides of the heart) or ventricle (lower chamber of the heart), can be fast or slow and can be regular or irregular. Symptoms of abnormal heart rhythms include:

  • unexplained heart palpations
  • trouble breathing
  • sweating
  • feeling pressure in one’s chest
  • passing out.

 

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About the Contributor

Jessica Davids
Cleveland
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

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