New injectable antibiotic approved, infusers recalled


Recalls, warnings

A voluntary recall of all 50 mg/2 mL and 250 mg/10 mL vials of Sandoz and Parenta brand methotrexate injection following the finding of small glass flakes during quality control.

Photo by Thinkstock
Photo by Thinkstock.

A nationwide recall of Triton Pole Mount Infusion Pumps, some of which have been found to have a problem with the pump door open alarm, potentially resulting in overinfusion of medication.

A recall of Fentanyl transdermal systems after laboratory testing identified a patch that released its active ingredient faster than the approved specification. An accelerated release can lead to adverse events, including excessive sedation, respiratory depression, hypoventilation and apnea.

New warnings on gonadotropin-releasing hormone (GnRH) agonists about the potential risk of heart disease and diabetes in men treated with these medications for prostate cancer. The warnings are based on an FDA analysis finding that patients receiving GnRH agonists were at a small increased risk for diabetes, heart attack, stroke and sudden death.

A new warning on the HIV antiviral drug saquinavir (Invirase), describing potential for changes in the electrical activity of the heart when patients take saquinavir with ritonavir (Norvir), another HIV antiviral medication. Torsades de pointes and complete heart block have been reported in patients taking the drugs together. Patients at particular risk are those with underlying heart conditions or those who have existing heart rate or rhythm problems. An electrocardiogram should be performed prior to initiation of treatment.

A nationwide recall of a lot of heparin sodium by distributor B. Braun after testing indicated a trace amount of oversulfated chondroitin sulfate contaminant.

A class I recall of Hospira Symbiq One-Channel and Two-Channel Infusers due to motor encoder failures in the pumping mechanism that cause the infusers to cease operation. Delay or interruption of therapy may result in serious injury or death in patients receiving critical therapy, pediatric patients and neonates.

A class I recall of SIGMA Spectrum Infusion Pump Model 35700 because the units may fail suddenly, causing inaccurate flow conditions during use, ranging from back flow to overinfusion, including free flow.

Approvals

Ceftaroline fosamil (Teflaro), an injectable antibiotic to treat adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus. Ceftaroline fosamil is a cephalosporin and clinical trials found its effectiveness comparable to ceftriaxone (Rocephin) and vancomycin (Vancocin) plus aztreonam (Azactam).

A new indication for duloxetine hydrochloride (Cymbalta) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. The drug was first used to treat major depressive disorder in 2004.

A new indication for dasatinib (Sprycel) for the treatment of Philadelphia chromosome-positive chronic-phase chronic myeloid leukemia when it is first diagnosed. In June 2006, the FDA granted accelerated approval to the drug to treat chronic-phase chronic myeloid leukemia in adults who had resistant disease or who were intolerant to prior therapy.

A new indication for everolimus (Afinitor) to treat subependymal giant-cell astrocytoma associated with tuberous sclerosis, in cases that cannot be treated with surgery. The new use was approved under the FDA's accelerated approval program; the drug was first approved in March 2009 to treat kidney cancer.

Tesamorelin (Egrifta) to treat HIV patients with lipodystrophy, a condition associated with antiretroviral treatment in which excess fat develops in different areas of the body. The medication is a growth hormone-releasing factor drug administered in a once-daily injection and the first FDA-approved treatment for lipodystrophy. Patients in clinical trials showed greater reductions in abdominal fat as measured by computed tomography (CT) scan compared to those on placebo. It has not been studied whether the drug decreases the risk of cardiovascular disease or improves compliance with antiretroviral regimens.