Warning: dm Meds Pioglitazone

The FDA has issued an expanded warning label about type 2 diabetes medications containing Pioglitazone, which includes Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni.  The FDA has concluded that Pioglitazone does increase the risk of bladder cancer, and recommends that it not be prescribed for patients with bladder cancer, and that all others using it watch for blood or a red color in the urine, new or worsening urge to urinate, or pain when urinating, any of which could indicate possible bladder cancer.  For full details see http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm532772.htm .

Warning: Saxagliptin and Alogliptin in dm Meds

The FDA has warned that diabetes medications Containing Saxagliptin and Alogliptin may increase risk of heart failure, particularly in patients who already have heart or kidney disease, and has added new warnings to the drug labels for 

  • Onglyza (saxagliptin)
  • Kombiglyze XR (saxagliptin and metformin extended release)
  • Nesina (alogliptin)
  • Kazano (alogliptin and metformin)
  • Oseni (alogliptin and pioglitazone)

See http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494252.htm for full details.

Recall Now Class I: Advocate Redi-Code+ Test Strips

The FDA has announced that the earlier recall of Advocate Redi-Code+ Blood Glucose Test Strips model BMB-BA006A has been upgraded to Class I, indicating potential for serious injury or death.  For the earlier notice see https://nwrnbulletins.wordpress.com/2014/06/11/recall-advocate-redi-code-test-strips/; for the current upgrade see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm406243.htm.

Benicar/Olmesartan Alert Revised

The FDA has announced that after review, it has revised its previous warning about possible increased risk of cardiovascular events when diabetic patients use olmesartan to reduce blood pressure.  Olmesartan is sold as Benicar, Benicar HCT, Azor, Tribenzor, and Generics.  While the FDA concludes that benefits outweigh risks, they are asking that information from some of the studies they reviewed be included in the drug label.  For details see http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402616.htm.

 

Recall: Advocate Redi-Code+ Test Strips

The FDA has announced a recall of Advocate Redi-Code+ Blood Glucose Test Strips model BMB-BA006A because of confusion about labeling.  The strips are made by BroadMaster Bio-Tech Corp and distributed by Diabetic Supply of Suncoast, Inc.  Current labeling could lead consumers to use the strips in the wrong blood glucose meter, resulting in incorrect readings.  While the FDA has not labeled this recall Class I, their announcement does cite the possibility of serious injury or death.  For details see http://www.fda.gov/Safety/Recalls/ucm400559.htm.