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.
The FDA has issued a warning that pre-owned or unauthorized test strips for insulin, warfarin, and other uses may produce inaccurate results with possible serious consequences. For details see https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635478.htm.
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.
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
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 .
The FDA has warned that the diabetes drug Canagliflozin (Invokana, Invokamet) is associated with increased risk of amputation. For details see https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm558605.htm .
The FDA has issued a warning about diabetes medications containing Pioglitazone, including Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni, because of elevated risk of bladder cancer. For details see http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm532772.htm .