Recalls, warnings and alerts
An order to strengthen warnings on prescribing information of four tumor necrosis factor-a blockers (TNF blockers) about the risk of developing opportunistic infections. The drugs are adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel) and infliximab (Remicade). Providers aren't consistently recognizing cases of histoplasmosis and other invasive fungal infections in patients who take these drugs, which has led to delays in treatment and sometimes death.
A Class I recall of Pacific Consolidated Industries' Mobile Oxygen Storage Tank, manufactured and distributed between January and March 2007, because the pressure gauge may rupture and catch fire from hydraulic fluid n the pressure gauge tubing. Facilities that have the Mobile Oxygen Storage Tank should keep it in quarantine until arrangements are made to ship it back to the manufacturer.
A recall of 25 mg/vials of Thymoglobulin (generic name: anti-thymocyte globulin [Rabbit]) because lot number C7010C01 failed a periodic stability test based upon appearance of the reconstituted product. Providers and hospitals should return the product to the manufacturer, Genzyme Corporation. A similar recall of three other lots of Thymoglobulin went into effect last April.
An alert to discontinue exenatide (Byetta) if a patient appears to develop pancreatitis. Six cases of hemorrhagic or necrotizing pancreatitis were reported in the last year in patients taking Byetta; two died. Patients with a history of pancreatitis should be considered for antidiabetics other than Byetta.
A recommendation to screen patients for the human leukocyte antigen (HLA) allele, HLA-B*5701 prior to administering abacavir (Ziagen) and abacavircontaining medication, since serious hypersensitivity reactions are more common in these patients. If patients screen positive, alternative therapy should be used.
A reminder that left ventricular ejection fraction (LVEF) should be evaluated before initiating treatment with, and administering each dose of, mitoxantrone. Previous post-marketing reports about decreases in LVEF or frank congestive heart failure in some patients led to recommendations about monitoring patients, but research indicates there is poor adherence to these recommendations.
A Class I recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008, because the tip of the stent delivery system may detach during a procedure. The recall doesn't affect stents that have already been implanted.
An alert that two new cases of progressive multifocal leukoencephalopathy (PML) have been reported in European patients taking natalizumab (Tysabri) monotherapy for multiple sclerosis (MS) for more than a year. Previous cases were seen only in patients with MS who took natalizumab as part of combination therapy with immunomodulatory agents. Prescribing information will change to reflect the new cases.
Tenofovir disoproxil fumarate (Viread) for chronic hepatitis B in adults, with a recommended daily dose of 300 mg. The drug has been available in the U.S. since 2001 to treat HIV infection. Patients who discontinue Viread should be monitored closely for several months, as acute exacerbations of hepatitis have occurred in those who stopped treatment.
Oral capsules of palonosetron hydrochloride (ALOXI), which prevents chemotherapy-induced nausea and vomiting when administered one hour before the therapy. The intravenous form of ALOXI has been available in the U.S. since 2003.
AlloMap, a non-invasive test that uses gene expression techniques to help determine the risk of organ rejection for heart transplant patients after surgery.