Warnings on prostate drugs, HIV combination therapy

Recalls, warnings, and approvals.

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.


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 before starting 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 new indication for dasatinib (Sprycel) for the treatment of 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.

Lurasidone HCl tablets (Latuda) for treatment of adults with schizophrenia. Lurasidone is an atypical antipsychotic, and as such will carry a boxed warning alerting prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis.

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 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.

A new indication for duloxetine hydrochloride (Cymbalta) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain.


In response to reports that patients undergoing CT brain perfusion scans were accidentally exposed to excess radiation, the FDA has identified some potential equipment enhancements that could improve patient safety.

The improvements, which the FDA has proposed to the Medical Imaging and Technology Alliance (the major professional industry organization for manufacturers of CT scanners and other radiological imaging devices), include:

  • a console notification to alert the operator of a high radiation dose;
  • provision of particular information and training on brain-perfusion protocols to all facilities that receive base CT equipment, whether or not the facilities purchase the related software enabling quantitative analysis of cerebral hemodynamics;
  • clarification of parameters affecting dose, along with clear instructions on how to appropriately set those parameters; and
  • organization of all dose-related information into one section of each user manual or in a dedicated dose manual, or indexed comprehensively in a concordance covering all manuals.