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 .
The FDA has issued a warning about malfunction of Implantable Infusion Pumps that are, or have been, exposed to high-EMF environments such as MRI machines. For details see http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm536526.htm .
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 .
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)