FDA Issues Warning for Avycaz for Dosing Error Potential
About the FDA Warning
Avycaz is an antibacterial drug manufactured by Forest Labs, it was approved by the FDA in February 2015 for intravenous administration in order to treat internal infections.
Since gaining its approval, the FDA has received three reports of medication errors related to dosing. According to the FDA, these errors are due to confusion created by the manner in which the dosage strength is displayed on the drug’s carton and vials.
Originally, labels were approved to display individual strengths of the two active ingredients of Avycaz; however, new labels are dosed based on the sum of the active ingredients.
The FDA urges both patients and medical professionals to report any dosage mistakes or adverse side effects arising from the use of Avycaz to MedWatch: The FDA Safety Information and Adverse Event Reporting Program online.
Avycaz Instances Reported to the FDA
- Three separate incidents have been reported since the drug’s February approval.
- Two reports concern pharmacy errors in which incorrect dosages were prepared by the pharmacy staff.
- One report confirms that a patient was given a higher than intended dose by medical staff during treatment.
- No adverse effects have been reported as of yet.