New warnings on tigecycline, ofatumumab

Details on recalls, warnings and approvals.

Recalls and warnings

A new boxed warning on intravenous tigecycline (Tygacil) about the increased risk of death associated with its use compared to other antibacterial drugs. Clinicians should only use the drug when alternative treatments are not suitable. Tigecycline is approved to treat complicated skin and skin structure infections, complicated intra-abdominal infections and community-acquired bacterial pneumonia, not for diabetic foot infection or hospital-acquired or ventilator- associated pneumonia.

Image by Thinkstock
Image by Thinkstock.

A new boxed warning and recommendations on ofatumumab (Arzerra) and rituximab (Rituxan) regarding the risk of hepatitis B virus (HBV) reactivation. Clinicians should screen all patients for HBV infection before starting treatment with either drug, consult with hepatitis experts when screening identifies patients at risk of reactivation, and monitor patients with evidence of prior infection for signs of reactivation during therapy and for several months thereafter. In patients who develop reactivation, clinicians should immediately discontinue the drug and start appropriate treatment.

A health advisory that several acute nonviral hepatitis cases have been linked to use of OxyElite Pro, a dietary supplement. Twenty-nine cases, including 1 death, have been identified in Hawaii, and the CDC is looking at other cases of liver injury nationwide that may be related.

A recall of 1 lot of metoclopramide injection, USP, 10 mg/2 mL (5 mg/mL), and two lots of ondansetron injection, USP, 4 mg/2 mL (2 mg/mL), by Hospira due to a confirmed defect in which glass particulates were affixed to the inside of the vial walls, with potential for the particulates to dislodge into the solution and cause complications.

A recall of some emergency cricothyrotomy kits by H&H Medical Corporation due to potential for a defective cuff balloon on the provided endotracheal airway. The cuff balloon may be defective due to a very particular set of circumstances that occurred in the production process.

A recall of 1% lidocaine HCL injections, USP, 10 mg/mL, 20-mL multiple-dose fliptop vial, by Hospira due to 1 confirmed customer report of visible particulate, which was identified as oxidized stainless steel. If undetected, it could block administration of the drug to the patient.

A recall of 2 lots of dual luer lock caps by Baxter due to the presence of loose particulate matter in the packaging. Particulate matter entering the fluid path may result in thrombotic and embolic events, including pulmonary embolism, myocardial infarction and stroke.

An alert that budesonide solution from The Compounding Shop may be contaminated and should not be used or administered to patients.

A recall of certain Fabius anesthesia machines due to a power supply issue; on some units from a particular batch, the required minimum clearance between an electrical component and the unit housing was not maintained, which could potentially cause a failure of the automatic ventilation function of the device. If such a fault occurs, an audible and visual alarm is generated.


A new lipid injectable emulsion (Clinolipid) for parenteral nutrition in adult patients. The emulsion contains a mixture of refined olive oil and refined soybean oil and was granted a priority review to help alleviate a drug shortage. The FDA noted that the omega-3:omega-6 fatty acid ratio in Clinolipid has not been shown to improve clinical outcomes compared to other lipid emulsion products. Like other intravenous lipid emulsions, it should be used with caution in patients with preexisting liver disease or liver insufficiency and should not be used in patients with severe hyperlipidemia or a known hypersensitivity to egg or soybean proteins. Safety and effectiveness were evaluated in comparisons with a soybean oil-based lipid emulsion. The most common side effects included infectious complications, nausea and vomiting, excess lipids in the blood, high blood sugar, low levels of protein in the blood and abnormal liver function tests. It is not indicated for use in pediatric patients.

The first generic version of capecitabine (Xeloda) to treat metastatic colorectal and breast cancer, in 150- and 500-mg strengths.