Safety Alerts & Recalls
Search all Safety Alerts & Recalls
Latest Alerts
FDA Warns: Abnormal Heart Rhythms May Be Associated with Use of High Dose Zofran (Ondansetron)
The U.S. Food and Drug Administration (FDA) has informed healthcare professionals that early results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran) may affect the electrical activity of the heart (QT interval prolongation), which could increase a patients risk of developing an abnormal and potentially fatal heart rhythm known as Torsades de Pointes. Zofran and its generics (ondansetron) are used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery.
GlaxoSmithKline (GSK) has announced changes to the Zofran drug label to remove the 32 mg single intravenous dose. The updated label will state that ondansetron can continue to be used in adults and children with chemotherapy-induced nausea and vomiting at the lower intravenous dose, a dose of 0.15 mg/kg administered every 4 hours for three doses; however, no single intravenous dose should exceed 16 mg. Information from the new clinical study will be included in the updated drug label.
As part of the ongoing safety review of ondansetron, the FDA continues to assess data about the risk of QT prolongation and will update the public when more information becomes available.
For more information, please visit:
http://www.fda.gov/Drugs/DrugSafety/ucm310190.htm
Learn More
FDA Issues Drug Safety Communication about the Risk of Seizures with Ampyra (Dalfampridine)
The U.S. Food and Drug Administration (FDA) is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine). Using information received from post-market adverse event reports, FDA recently evaluated seizure risk in MS patients taking Ampyra (dalfampridine). The majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures.
Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug. Ampyra is eliminated from the body through the kidneys, and patients with kidney impairment may develop higher blood levels of the drug, thereby increasing their seizure risk.
The FDA is also updating the Ampyra prescribing information to clarify recommendations that kidney function should be checked in patients before starting Ampyra and monitored at least annually while Ampyra treatment continues. Additionally, patients who miss a dose should not take extra doses — an extra dose of Ampyra can increase seizure risk.
Ampyra contains the active ingredient dalfampridine and is used to improve walking in patients with MS.
For more information, please visit:
http://www.fda.gov/Drugs/DrugSafety/ucm312846.htm
Learn More