FDA, "GenStrip Blood Glucose Test Strips by Shasta Technologies: FDA Safety Communication - May Report False Results," April 29, 2014.
The FDA is advising patients to stop using GenStrip Blood Glucose Test Strips, sold by Shasta Technologies LLC, because the strips may report incorrect blood glucose levels. The GenStrips are sold for use with the LifeScan OneTouch family of glucose meters (e.g. Ultra, Ultra 2 and Ultra Mini). According to the FDA Safety Communication, "During a recent inspection of Shasta Technologies LLC, the FDA found extensive violations of federal regulations intended to assure the quality of products in the manufacturing of GenStrip Test Strips. FDA found that Shasta Technologies did not have in place many of the requirements of a quality system. Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels." Read more Diabetes Treatment Alerts.
 FDA, "GenStrip Blood Glucose Test Strips by Shasta Technologies: FDA Safety Communication - May Report False Results," April 29, 2014.
The FDA has approved Tanzeum (albiglutide), manufactured by GlaxoSmithKline, as a new injection to help control blood sugar levels in adults with type 2 diabetes. Tanzeum can be used alone or together with existing treatment regimens to control blood sugar levels in the overall management of diabetes.
In clinical trials, the most common side effects observed in patients treated with Tanzeum were diarrhea, nausea, and injection site reactions. The FDA advices that Tanzeum should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or as first-line therapy for patients who can’t be managed with diet and exercise.
The FDA is also requiring a Boxed Warning for Tanzeum to warn that tumors of the thyroid gland have been observed in rodent studies, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Tanzeum should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (a disease where patients have tumors in more than one gland in their body and that predisposes them to MTC).
To learn more, the FDA is requiring the following post-marketing studies for Tanzeum:
Read More Diabetes Treatment Alerts
Yesterday the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 1 to recommend approval of Afrezza, a form of insulin that is inhaled rather than injected. Developed by MannKind Corporation, Afrezza would be a new option for millions of diabetics. Although there were more cases of lung cancer among those who received Afrezza in clinical trials than in control groups, the numbers were small. Longer-term studies of the risk of long-term exposure of the lungs to insulin would be needed to more definitively assess the risk of lung cancer. In the past, major pharmaceutical companies Pfizer, Novo Nordisk and Eli Lilly had abandoned efforts to offer inhaled insulin. The founder of MannKind Corporation, aerospace and medical device entrepreneur Alfred E. Mann, believes that the Afrezza inhaler will be more successful because it is smaller and easier to use than Pfizer's abandoned product Exubera. In clinical trials, Afrezza was less effective than injected insulin in reducing blood sugar for Type 1 diabetics, but performed marginally better for those with Type 2 diabetes. MannKind suggested that inhaled insulin would appeal to patients who might otherwise avoid or delay injection insulin treatments. The panel vote is not binding on the FDA, but the FDA usually follows the panel's recommendation.
 Radick, L. "FDA Panel Says Yes to Inhaled Insulin Device," medpage TODAY (April 1, 2014).
 Pollack, A. "Inhaled Insulin Clears Hurdle Toward F.D.A. Approval," The New York Times (April 1, 2014).
 Edney, A. "MannKind Wins U.S. Panel Backing for Inhaled Insulin," Bloomberg (April 2, 2014).
Following an inspection of the San Diego company Dexcom, Inc., on March 14 the FDA issued a warning letter to the company regarding alleged misbranding violations under the FDA's Medication Device Reporting (MDR) Regulation. The FDA cited the firm's failure to provide FDA with required information regarding reported injuries sustained by patients while using Dexcom's G4 Platinum continuous glucose monitor. Events that were unreported included cases of patients developing hypoglycemia while using the device and evidence that the device malfunctioned and caused electrical shocks. The FDA required Dexcom to submit a response to the letter within fifteen business days addressing all violations and stating the time in which corrections will be made.
 FDA Warning Letter, Dexcom Inc. ( 3/14/14).
The FDA announced Abbott is conducting a recall for its FreeStyle and FreeStyle Flash Blood Glucose Meters. When used with Abbot FreeStyle test strips, the meters may produce mistakenly low blood glucose results. These meter models have not been in production since 2010. People using the meters should contact Abbott Diabetes Care at 1-888-345-5364 to obtain a replacement meter. See the full press release for additional information and recommendations.
 FDA, Recall--Firm Press Release, "Abbott Issues Recall of Certain Blood Glucose Monitoring Systems," (March 14, 2014).
The FDA reported seeing problems at the German facility where the Type 2 diabetes drug empagliflozin will be manufactured and told makers Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Co. that the deficiencies need to be corrected before it can approve the new drug application. Empagliflozin is designed to remove excess glucose through the urine by blocking re-absorption by the kidneys.
 Zaggar, Z. "Eli Lilly, Boehringer Diabetes Drug Faces FDA Roadblock," Law360 (March 5, 2014).
During inspections of the Baxter Healthcare Corporation facilities in Illinois and California, the FDA found multiple violations in the manufacturing of its HomeChoice dialysis device and its elastomeric infusion pumps. In a January 17, 2014, warning letter the FDA cited continuing problems with component failures in the HomeChoice peritoneal dialysis systems manufactured by the Illinois plant. The December 19, 2013 letter cited complaints of bladder ruptures in the infusion pumps manufactured in California. The FDA warned Baxter that the company's prevention efforts and response to the violations have been inadequate.
 FDA Warning Letter, WL# 07-14 (Baxter Healthcare Corporation), December 19, 2013.
 FDA Warning Letter, CHI-2-14 (Baxter Healthcare Corporation), January 17, 2014.
Tandem Diabetes Care announced a voluntary recall of specific lots of insulin cartridges used with the t:slim Insulin Pump because they may leak. The t:slim system consists of the following components and accessories: (1) a software-controlled, programmable insulin infusion pump (t:slim Pump) capable of both basal and bolus delivery of insulin; (2) a dedicated, disposable 3mL (300 unit) insulin cartridge; (3) UnoMedicals Comfort" Infusion Set (K051264), or an equivalently cleared set; and (4) additional device accessories including a Becton Dickinson 3mL sterile syringe and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply with USB for charging the Pumps internal battery, cartridge Instructions for Use, and Users Guide. Lot numbers affected by the recall and instructions for obtaining replacements cartridges are contained in the official recall notice here.
Earlier this month FDA approved Farxiga (dapaglifozin), a new tablet from Bristol-Meyers Squibb Co. and AstraZeneca Pharmaceuticals to help improve glycemic control in adults with type 2 diabetes. Because an increased number of bladder cancers were diagnosed among Farxiga users in clinical trials, Farxiga is not recommended for patients with active bladder cancer. Side effects of Farxiga include genital mycotic (fungal) infections, urinary tract infections, and dehydration which can lead to a drop in blood pressure (hypotension), dizziness and/or fainting and a decline in renal function. The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to these risks. The FDA is requiring 6 post-market studies of Farxiga:
 FDA News Release, "FDA approves Farxiga to treat type 2 diabetes" (Jan. 8, 2014).
Jurors in a state court in Baltimore found that Takeda Pharmeceutical Co. failed to properly warn about the risks of its Actos diabetes drug and ordered the company to pay more than $1.7 million in damages for the cancer death of plaintiff Diep An. The judge, however, threw out the verdict based on the finding that An contributed to his own death by smoking for thirty years.
Similarly, in April, a California jury ordered Takeda to pay $6.5 million in a damages to a diabetic man who claimed Actos caused his bladder cancer. The judge in that case also threw out the verdict.
Although not resulting in a win for the plaintiffs, the two jury verdicts are vindication for claims that Takeda failed to properly disclose Actos's link to bladder cancer. Takeda faces more than 3,000 other lawsuits over the drug. More than 1,200 of the cases have been consolidated in multi district litigation in Louisiana. The first of those cases goes to trial in January 2014.
 An v. Nieberlein, 24-C12003565, Circuit Court for the City of Baltimore, Maryland.
 Feeley, J. "Takeda Failed to Properly Warn About Actos Risks, Jury Rules" Bloomberg Businessweek (September 26, 2013).