Extended-Release Metformin Recalls

The FDA has announced the recall of seven formulations of extended-release Metformin because of contamination by the carcinogen MDNA.  The recalls include:

Warning: Medtronic MiniMed Insulin Pumps

The FDA has warned that certain Medtronic MiniMed Insulin Pump models are not protected from hackers, who could alter the insulin settings.  Medtronic is replacing the inadequately protected pumps.  For recommendations on protecting yourself while awaiting a replacement, a list of models and software versions involved, and more information, see https://www.fda.gov/medical-devices/safety-communications/certain-medtronic-minimed-insulin-pumps-have-potential-cybersecurity-risks-fda-safety-communication.

FDA Warning re Cipro et al and Blood Sugar

The FDA has required new label warnings about blood sugar and mental health side effects of fluoroquinolone antibiotic drugs.  The most common fluoroquinolones are Cipro (ciprofloxacin), Avelox (moxifloxacin), and Levaquin (levofloxacin), but there are many others, most of which end in -floxacin.  The new label has many specific warnings and recommendations for diabetics.  For full details see https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm612979.htm.

Recall: Roche Accu-Chek Aviva/Performa Test Strips

Certain lots of Accu-Chek Aviva and Performa test strips have been recalled by Roche Diabetes Care because some strips may give error messages or incorrect readings, which could result in treatment errors.  Lots recalled include:

  • Accu-Chek Aviva 10 test strip pots, lots #497344, 497392
  • Accu-Chek Aviva 50 test strip pots, lots #496802, 496807, 496809, 496915, 497391, 497392
  • Accu-Chek Performa 10 test strip pots, lots #476597, 476646
  • Accu-Chek Performa test strips in Nano blood glucose kits, lots #10153111, 10153112, 10153114, 10153115, 10153116

For more information see https://www.diabetes.co.uk/news/2018/may/roche-announces-urgent-recall-on-certain-accu-chek-aviva-and-performa-test-strips-91431166.html.

Recall: Riomet Metformin Oral

The FDA has announced the recall of two lots of Sun Pharmaceutical Industries Riomet brand Metformin Hydrochloride Oral Solution:

  • NDC Code 10631-206-01 Lot A160031A
  • NDC Code 10631-206-02 Lot A160031B

Both lots Expire 01/2018.  These lots were found to be contaminated with Scopulariopsis brevicaulis, which can cause pneumonia, sinusitis and disseminated infections, especially in immunocompromised patients.  For details see https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586510.htm .

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 .