Heparin labeling changed, non-egg flu vaccine approved

This regulatory update covers changed labeling for heparin and approval of a flu vaccine produced using cultured animal cells.

Recalls, warnings and label changes

A market withdrawal of the 32-mg, single intravenous dose of ondansetron hydrochloride (Zofran) due to the risk found with that dose of QT interval prolongation, which can lead to torsades de pointes.


A change to the container and carton labels for heparin products to clearly state the strength of the entire container of the medication followed by how much of the medication is in 1 mL. The change to heparin lock flush solution and heparin sodium injection will eliminate the need for health care professionals to calculate the total amount of heparin in a product containing more than 1 mL, reducing the risk of miscalculations that may result in medication errors.

A recall of certain lots of Qualitest hydrocodone bitartrate and acetaminophen tablets 10 mg/500 mg because some tablets may be oversized and contain a higher dosage of acetaminophen. Increased acetaminophen intake could result in liver toxicity, especially in patients on other acetaminophen-containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.

A class I recall of nine lots of iopamidol injection pre-filled power injector syringes (Isovue PFS) due to the presence of visible particulates. No reports of adverse events or customer complaints have been received but the visible particles have the potential to cause adverse health consequences.

A recall of 41 affected lots of atorvastatin calcium tablets (10 mg, 20 mg and 40 mg) by Ranbaxy Inc. due to the possibility that the affected lots may contain very small glass particles. Because of the size of the particles, significant safety concerns are unlikely but the possibility of adverse experiences, arising primarily due to physical irritation, cannot be ruled out.

A voluntary recall of the A3/A5 anesthesia delivery system by Mindray due to the possibility of a system leak resulting from improper seating of the CO2 absorbent canister gasket, which could cause an interruption of or inadequate patient anesthesia and ventilation, temporary or permanent patient injury, or death, as well as injury to bystanders and operating room personnel.

A class I recall of the HeartSine Samaritan 300/300P public access defibrillator because devices have been found to intermittently turn on and off, which may eventually deplete the battery. Also, certain devices may misinterpret a temporary drop in battery voltage as signaling a low battery, resulting in the device turning itself off. A device experiencing either condition could be unable to deliver therapy during a cardiac event.

A voluntary recall of certain GlideScope GVL video laryngoscopes reusable blades because they have been found to be prone to developing cracks and/or breaking across the tip of the blade, which potentially could result in pieces of the blade breaking off in patient's mouths and obstructing the airway or being swallowed.

A recall of Life Pulse high-frequency ventilator patient circuits by Bunnell Incorporated because they have been found to have heater wire insulation that can melt, causing sparking and smoke close to the humidifier cartridge, which could potentially result in patient injury or death.


Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. In a trial, the vaccine was 83.8% effective in preventing influenza compared to placebo. Reactions were typical of those seen with current influenza vaccines.

The HeartWare Ventricular Assist System, a left ventricular assist device, to support heart function and blood flow in patients with end-stage heart failure who are awaiting a heart transplant. The implantable pump with an external driver and power source is designed for use inside or outside the hospital and is small enough to be implanted in the chest rather than the abdomen. It was approved based on data from the ADVANCE trial.

The Zilver PTX stent, the first drug-eluting stent indicated to re-open the femoropopliteal artery when narrowed or blocked as a result of peripheral artery disease. The paclitaxel-coated stent was approved based on trials which found it to be at least as safe as and significantly more effective than percutaneous transluminal angioplasty and bare-metal stents.

Cabozantinib (Cometriq) to treat medullary thyroid cancer that has metastasized. The safety and effectiveness of this kinase inhibitor were established in a placebo-controlled study in which patients taking the drug had an average 11.2 months progression-free survival compared to four months on placebo. It carries a boxed warning about the risk of severe and fatal bleeding and perforations and fistula in the colon.

An expanded approval of abiraterone acetate (Zytiga) to treat metastatic castration-resistant prostate cancer prior to chemotherapy. The drug was initially approved in November 2011 for use in patients whose prostate cancer progressed after treatment with docetaxel. In a trial of patients who hadn't received chemotherapy, the drug increased overall and progression-free survival compared to placebo.