American College of Physicians: Internal Medicine — Doctors for Adults ®

Advertisement

Warnings on prostate drugs, HIV combination therapy

From the January ACP Internist, copyright 2011 by the American College of Physicians

By Stacey Butterfield

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.

Warnings on prostate drugs, HIV combination therapy

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.

Approvals

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.

Miscellaneous

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.

Top

This is a printer-friendly version of this page

Print this page  |  Close the preview

Share

 
 

Internist Archives Quick Links

Internal Medicine Meeting Early Registration Discount

Internal Medicine Meeting Early Registration Discount

Register early for Internal Medicine Meeting 2015 in Boston, MA to lock in the lowest possible rate. Learn more or register now!

Are You Using ACP Smart Medicine®?

Are You Using ACP Smart Medicine?

This online clinical decision support tool is a FREE benefit of ACP membership delivering point-of-care access to evidence-based recommendations. Includes more than 500 modules, images and reference tables. Start now or watch the video tour.