February 24, 2012
Meter Recalled; New Diabetes Medicine Approved
Diane FennellMeter Recalled
On February 21, 2012, LifeScan voluntarily issued a recall of the OneTouch Verio IQ blood glucose meter due to an error that, under very specific circumstances, “causes the meter to turn itself off when a user attempts to access the ‘Results Log’ to view stored test results.” If this happens, the meter enters the set-up mode the next time it is turned on, requiring the user to confirm the date and time settings before it can be used for a blood glucose check.
According to LifeScan, the issue does not affect either the accuracy of the results or functions such as averaging, downloading, and result tagging, and no data is lost. However, because monitoring is not possible without reconfirming the settings — potentially leading someone to delay treatment or to make a treatment decision without blood glucose data — LifeScan is offering all OneTouch Verio IQ meter users a replacement meter free of charge.
To receive a replacement meter, call LifeScan at (888) 567-3003 to verify your meter’s serial number and confirm your mailing address. According to the company, while waiting for your replacement meter, you can continue to use your OneTouch Verio IQ. Test strips for the meter are not affected by the recall.
For more information, including instructions on how to confirm the date and time settings on your meter in case of malfunction, click here.
New Diabetes Medicine Approved
Continuing a busy few months for the FDA, the administration recently approved sitagliptin/metformin HCl (brand name Janumet XR), an oral combination medicine for Type 2 diabetes manufactured by Merck. Janumet combines the DPP-4 inhibitor sitagliptin (Januvia) with the extended-release version of the common diabetes medicine metformin.
DPP-4 inhibitors work by helping a hormone known as incretin to stimulate the release of insulin, slow stomach emptying, inhibit the release of glucagon (a hormone that signals the liver to release glucose), and enhance the survival and growth of the insulin-producing beta cells. Metformin works by decreasing glucose production by the liver, as well as improving insulin sensitivity in the liver, muscle, and fat cells.
Janumet XR is approved for use in conjunction with diet and exercise in adults with Type 2 diabetes. The tablet should be taken once daily with a meal, preferably in the evening, and is available in doses of 100 milligrams of sitagliptin/1,000 milligrams of metformin extended-release, 50 milligrams of sitagliptin/500 milligrams of metformin extended-release, and 50 milligrams sitagliptin/1,000 milligrams of metformin extended-release, respectively.
This medicine has not been studied in combination with insulin and should not be used to treat Type 1 diabetes or diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body). It should not be used in people with kidney impairment or an allergy to any of the ingredients, and it has not been studied in people who have pancreatitis.
The most common side effects of Janumet XR are diarrhea, upper respiratory tract infection, and headache.
According to information provided by Merck, the cost of Janumet XR will be comparable to that of both Januvia and Janumet on a per-daily-dose basis. The medicine is expected to be widely available in US pharmacies within the next few weeks.
For more information, see the press release on the Merck Web site.
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