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FDA Article Archives

April 2014

Prodigy Diabetes Care Moves Forward After FDA Concludes Regulatory Action

CHARLOTTE, N.C., April 16, 2014 /PRNewswire/ -- On April 10, 2014 the U.S. Food & Drug Administration (FDA) issued a "Closeout" letter to Prodigy Diabetes Care to formally conclude the regulatory action that resulted in a Warning Letter on February 22, 2013.

comments 0 comments - Posted Apr 21, 2014

Inhaled Insulin to Treat Diabetes Earns FDA Committee Recommendation

The inhaled insulin Afrezza has been recommended for approval by a Food and Drug Administration (FDA) advisory committee.

comments 0 comments - Posted Apr 12, 2014

March 2014

FDA Delays Final OK for Type 2 Drug Empagliflozin

The FDA will delay allowing the type 2 drug empagliflozin to enter the U.S. market until "previously observed deficiencies" at the plant where it is manufactured are fixed.

comments 0 comments - Posted Mar 23, 2014

FDA Backtracks Over GLP-1s' Effects on Pancreas

The U.S. Food and Drug Administration reports that its review of various animal and human studies does not show a link between GLP-1 drugs used to treat type 2 diabetes and pancreatic maladies, including acute pancreatitis and pancreatic cancer.

comments 0 comments - Posted Mar 4, 2014

More Than 180 New Diabetes Drugs in Development

A total of 182 new drugs to treat diabetes or diabetes-related conditions are currently in clinical trials or undergoing review by the U.S. Food and Drug Administration, according to a report just published by the Pharmaceutical Research and Manufacturers of America (PhRMA).

comments 0 comments - Posted Mar 1, 2014

February 2014

FDA Approves Dexcom G4 Platinum CGM Use for Children 2-17

The U.S. Food and Drug Administration has approved the expanded use of the Dexcom G4 Platinum Continuous Glucose Monitoring System for patients with diabetes ages 2 to 17 years. The G4 Platinum System, which monitors blood glucose levels in people with diabetes, had been approved for patients ages 18 and older.

comments 0 comments - Posted Feb 4, 2014

January 2014

FDA Proposes Separate Guidelines for Home vs. Clinical Glucose Meters

The Food and Drug Administration is proposing separate guidelines for over-the-counter blood glucose meters compared to those used at the doctor's office or in other healthcare settings.

comments 0 comments - Posted Jan 23, 2014

Type 1 Drug Wins Orphan Status

DV-100, a drug designed to halt the body's autoimmune attack on pancreatic beta cells that leads to type 1 disease, has won orphan drug status from the U.S. Food and Drug Administration.

comments 0 comments - Posted Jan 16, 2014

FDA Opens Way for Diabetic Macular Edema Device

The Food and Drug Adminsitration, reversing itself on a decision it made in October, has opened the way for a new treatment for diabetic macular edema to reach the U.S. market.

comments 0 comments - Posted Jan 1, 2014

December 2013

Is High Fructose Corn Syrup “the New Trans Fat"?

The non-profit consumer action group Citizens for Health earlier this month called on the Food and Drug Administration to do its part in raising awareness of the dangers of high fructose corn syrup by making an official statement recognizing the sweetener as an unsafe addition to the nation's food supply.

comments 0 comments - Posted Dec 13, 2013

August 2013

FDA Clears Novo's Kid-Friendly Insulin Pen

The U.S. Food and Drug Administration has granted 510(k) clearance for the NovoPen Echo®, the first insulin injection device on the market to combine half-unit dosing with a memory function to help patients manage their diabetes.

comments 0 comments - Posted Aug 22, 2013

July 2013

FDA Tells 15 Companies to Stop Illegal Diabetes Treatment Sales

The U.S. Food and Drug Administration has announced that it has issued letters warning 15 U.S. and foreign companies to cease sales of products that the agency has determined are being illegally marketed.

comments 1 comment - Posted Jul 27, 2013

June 2013

FDA Approves Invokana, a New Type 2 Drug

A new, first-in-its-class drug for type 2 diabetes has just been approved by the Food and Drug Administration. Invokana works by blocking re-absorption of glucose by the kidneys and stimulating urination, which removes glucose from the bloodstream.

comments 0 comments - Posted Jun 27, 2013

12th Q&A With Dr. Bernstein

Can Januvia Trigger Cancer Symptoms?

comments 1 comment - Posted Jun 12, 2013

FDA Panelists Vote to Ease Up on Avandia

A significant majority-20 of 26 members attending a combined meeting of FDA advisory committees-has voted to modify or remove the current restrictive label and distribution regulations affecting the type 2 drug Avandia.

comments 0 comments - Posted Jun 9, 2013

Ready for a Diabetes Drug Tune-Up?

People with diabetes know the score. We've all seen "revolutionary" drugs and treatments introduced with fanfare, and we know that that much of the time they're evolutionary at best. But something has changed in the world of diabetes care.

comments 2 comments - Posted Jun 1, 2013

April 2013

Smaller, Lighter OmniPod Earns FDA Approval

The FDA recently approved the next-generation OmniPod from Insulet, giving people with insulin-dependent diabetes an even less invasive way to manage their diabetes.

comments 0 comments - Posted Apr 19, 2013

March 2013

Could Pig Worms Lead to the Cure for Type 1?

Research into a cure for type 1 diabetes proceeds on several fronts. One interesting approach is seeking ways to manipulate the autoimmune system to prevent the body's mistaken destruction of pancreatic beta cells. Another tack is the transplantation of pancreatic tissue, either from human cadavers or carefully isolated "clean" pigs that have been specially raised for the purpose. 

comments 0 comments - Posted Mar 7, 2013

February 2013

Tandem Announces Two Partnerships

Tandem Diabetes Care, Inc. has teamed with Dexcom to expand an existing partnership to include development of Dexcom’s latest continuous glucose monitoring system, the G4 Platinum. The U.S. Food and Drug Administration approved the new CGM in October.

comments 0 comments - Posted Feb 17, 2013

Type 2: FDA OKs Canagliflozin But Has Concerns About Heart Risk

In a 10-5 vote, an FDA panel has recommended that the agency approve the marketing of Johnson & Johnson's InvokanaTM (canagliflozin), an oral once-daily drug for treating type 2 diabetes in adults.

comments 0 comments - Posted Feb 1, 2013

November 2012

Lilly Says Its New Injectible Outperforms Three Popular Diabetes Drugs

Good news for Eli Lilly & Co., as well as for type 2s who appreciate the addition of new drugs to treat their condition: Lilly says its once-weekly injectible drug, dulaglutide, has outperformed three other widely taken diabetes drugs in three just-concluded Phase III studies.

comments 0 comments - Posted Nov 20, 2012

FDA Approves Dexcom’s G4

The FDA has approved U.S. sales of Dexcom's G4TM PLATINUM continuous glucose monitor. The San Diego-based manufacturer said it is taking orders and plans to begin shipping the device to patients within the next few weeks.

comments 2 comments - Posted Nov 16, 2012

Lilly Says Its New Injectible Outperforms 3 Popular Diabetes Drugs

Good news for Eli Lilly & Co., as well as for type 2s who appreciate the addition of new drugs to treat their condition: Lilly says its once-weekly injectible drug, dulaglutide, has outperformed three other widely taken diabetes drugs in three just-concluded Phase III studies.

comments 0 comments - Posted Nov 5, 2012

October 2012

Oral Agents for Lowering Blood Sugar in Type 2 Diabetes

Author’s note: Throughout this series, I will inject my own opinion, which frequently differs from that of the medical establishment in this field. Having had diabetes for more than 66 years, I place my emphasis on the well-being of fellow patients.

comments 0 comments - Posted Oct 21, 2012

September 2012

Needle-Free CGM Could Be Available in 2013

Philadelphia-based Echo Therapeutics plans to introduce a needle-free continuous glucose monitoring system to the US market in 2013, pending FDA approval. The Symphony® tCGM is a two-part device that monitors blood glucose by taking readings through a user’s skin rather than via finger pricks. It is intended for use by anyone with diabetes, not just insulin pump users.

comments 1 comment - Posted Sep 26, 2012

August 2012

US Sale of Generic Actos Gets FDA Nod

The Food and Drug Administration has approved US sale of generic pioglitazone (trade name Actos) for the treatment of type 2 diabetes. Actos, originally developed and trademarked by Takeda Pharmaceuticals, works by decreasing insulin resistance in type 2 patients. The prescription drug, which belongs to the class of drugs known as thiazolidinediones (TZDs), has enjoyed great commercial success in the United States since its introduction in 1999, posting estimated sales last year of $2.7 billion.

comments 0 comments - Posted Aug 27, 2012

Social Media, Partnerships Are Top Topics at AADE12

As diabetes climbs to epidemic levels in the United States, and finding adequate resources to fund future U.S. healthcare remains in question, the need for an already existing "boots on the ground" group that can address the disease is greater than ever.

comments 0 comments - Posted Aug 15, 2012

July 2012

Type 1: New Drug Class Could Lead to Neuropathy Relief

University of California researchers report that they have found a new class of drugs that could lead to a pain relief treatment for people who have diabetic neuropathy. The drugs, which were successfully tested on lab animals, are anti-inflammatory compounds that inhibit the action of an enzyme called soluble epoxide hydrolase. The enzyme is key to the transmission of pain sensations. Previous research has shown that inhibiting soluble epoxide hydrolase also lowers blood pressure and protects against kidney damage.

comments 0 comments - Posted Jul 7, 2012

June 2012

ADA Sessions Spotlight Powerful Weapons Against Diabetes

Several hopeful trends emerged from this year's ADA Scientific Sessions in Philadelphia, held June 8 through 12.

comments 0 comments - Posted Jun 23, 2012

When Medical Devices Fail

Medical devices aren't just any old pieces of technology. Lives depend upon them. For that reason, the government outlined a process decades ago by which manufacturers and importers were supposed to report malfunctions. But there was one problem: When malfunctions occurred, the manufacturers and importers did not admit it. According to the Food and Drug Administration, "A 1986 General Accounting Office (GAO) study showed that less than one percent of device problems occurring in hospitals are reported to FDA, and the more serious the problem with a device, the less likely it was to be reported."

comments 0 comments - Posted Jun 22, 2012

Dexcom Proudly Sponsors Historic Diabetes Flight Formation Trip To Raise Juvenile Diabetes Research Foundation Funds Dexcom Proudly Sponsors Historic Diabetes Flight Formation Trip To Raise Juvenile Diabetes Research Foundation Funds

SAN DIEGO - June 15, 2012 - Dexcom, the leader in continuous glucose monitoring, is proudly sponsoring the efforts of the Diabetes Formation Flight USA(DFFUSA.org) - three pilots with insulin-dependent diabetes using Dexcom's Seven Plus as part of their effort to set new transcontinental world speed records while raising funds for the Juvenile Diabetes Research Foundation (JDRF).

comments 0 comments - Posted Jun 20, 2012

Type 1: FDA OKs Levemir for Two- to Five-Year-Olds

The US Food and Drug Administration has approved the use of Novo Nordisk's Levemir basal insulin for type 1 children aged two to five years. The FDA decision makes Levemir (insulin detemir [rDNA origin]) the only basal insulin approved for use in this age group.
Levemir, introduced to the US market in 2006, was previously approved for older children and adults with type 1 diabetes, as well as insulin-using type 2s.

comments 0 comments - Posted Jun 7, 2012

May 2012

Insulin degludec

Novo Nordisk's new variety of long-lasting insulin, insulin degludec, reduces low blood sugars while improving overall control, according to a pair of studies published in the prestigious journal The Lancet on April 27.

comments 0 comments - Posted May 8, 2012

April 2012

FDA Warns Diabetes Patients About Combining Aliskiren

On April 19, the US Food and Drug Administration issued a warning to diabetes patients not to combine the blood pressure medication aliskiren (Tekturna) with ACE inhibitors or angiotensin receptor blockers. The warning also applies to patients who have renal impairment.

comments 0 comments - Posted Apr 30, 2012

FDA Gives Go-ahead to Bayer’s CONTOUR® Next EZ

The US Food and Drug Administration has okayed US sales of Bayer HealthCare's CONTOUR® Next EZ blood glucose monitoring system. The new BGM, currently available in other countries as the CONTOUR XT, will be available in the US market this summer.

comments 0 comments - Posted Apr 25, 2012

Neuropathy Device Maker Files

NeuroMetrix, Inc., a Massachusetts-based medical device company, has filed a 510(k) form with the US Food and Drug Administration for the SENSUSTM, a pain therapy device for people who suffer diabetic neuropathy. A 510(k) is a "premarket notification" of a company's intent to market a medical product. The FDA then tests the product and provides feedback to the manufacturer. Once the FDA clears the product, its maker can introduce it to the US market.

comments 0 comments - Posted Apr 24, 2012

FDA Says Levemir OK for Pregnant Women

The U.S. Food and Drug Administration says that Levemir is safe for use by pregnant women and does not increase the risk of harm to children in the womb.

comments 0 comments - Posted Apr 4, 2012

March 2012

Keep Your Fingers Crossed: FDA Approves Artificial Pancreas Outpatient Trial

The FDA has approved the start of outpatient trials of a smart phone-based monitoring device that functions as an artificial pancreas. If the device, which automatically measures blood glucose levels and adjusts them with insulin, is successful, several million type 1 patients could enjoy a whole new level of convenience.

comments 9 comments - Posted Mar 27, 2012

ACP Guidelines Say Metformin Is the Best Starter Drug for Type 2s

The latest clinical guidelines for treating type 2 diabetes from the American College of Physicians (ACP) indicate that when diet, exercise, and weight loss fail to control blood sugar levels in early type 2 patients, physicians should prescribe metformin as the first drug therapy.

comments 2 comments - Posted Mar 1, 2012

February 2012

An Update on Bydureon

You've heard of the blockbuster drug Byetta, a daily injection for type 2 diabetes? Byetta's sister product, Bydureon, which is injected just once a week, has just been approved by the FDA and is available in pharmacies.

comments 11 comments - Posted Feb 17, 2012

Diabetes and Anemia:

There are lots of articles about diabetes, as well as all kinds of information about anemia. But what if you have both? About 25 percent of people with diabetes have some level of anemia. This article explains how the two conditions interact.

comments 3 comments - Posted Feb 16, 2012

An Inside View of Barley Beta Glucan

Barley has more beta glucan fiber than any other grain, and it has repeatedly established positive clinical results with regard to diabetes control. It not only boosts immune function by supporting macrophages and neutrophils, lowers blood pressure and cholesterol levels, and helps control obesity, but also attenuates postprandial glucose levels, improves insulin sensitivity, and promotes a feeling of satiety.

comments 6 comments - Posted Feb 5, 2012

FDA Gives Long-Awaited Nod to Amylin’s Bydureon

After several years of delays and setbacks, Amylin Pharmaceuticals has received FDA approval to begin US marketing of BydureonTM. The first once-a-week type 2 therapy to be offered in the US market, Bydureon is expected to be available by February. Amylin says that its wholesale price will be about $4,200 a year.

comments 2 comments - Posted Feb 3, 2012

January 2012

Animas Receives Warning Letter From the FDA

Animas Corporation, a division of Johnson & Johnson that manufactures insulin pumps, has been reprimanded by the FDA for not reporting serious problems resulting from use of its equipment. The parent company was warned that it could face fines and more for selling faulty insulin pumps and failing to disclose serious injuries to diabetic patients who used the OneTouch Ping and 2020 insulin pumps. According to reports, J&J continued to sell the pumps even after the company knew that some had failed.

comments 1 comment - Posted Jan 29, 2012

Roche’s New Nano SmartView Meter Doesn’t Need Coding

The FDA has given Roche the go-ahead to market its Accu-Chek® Nano SmartView blood glucose monitoring system. The Nano, which uses Accu-Chek SmartView test strips, will be available to US consumers within the first half of this year. It is part of the same product line as the Accu-Chek Aviva Nano and Accu-Chek Performa Nano systems, which Roche has already launched in several overseas markets.

comments 3 comments - Posted Jan 22, 2012

Dietary Supplements: Know Before You Swallow

A dietary supplement, also known as a food supplement or nutritional supplement, contains a "dietary ingredient" intended to supplement the diet by providing an element that might not otherwise be consumed. "Dietary ingredients" include vitamins, minerals, herbs and other botanicals, amino acids, and substances such as enzymes, organ tissues, and metabolites. Dietary supplements, which may be extracts or concentrates, come in many forms, including tablets, capsules, soft gels, gelcaps, liquids, powders, and bars.

comments 0 comments - Posted Jan 7, 2012

Instructional Video Available for Spring Universal Infusion Set

Spring Health Solutions, Inc., has released an instructional video describing its Spring Universal Infusion Set, recently approved by the FDA and Health Canada. The video, at www.SpringUniversal.com, is designed to help consumers properly use the product.

comments 0 comments - Posted Jan 4, 2012

December 2011

JDRF Says FDA Threatens Artificial Pancreas Technology

Will the federal government kill the artificial pancreas? The Juvenile Diabetes Research Foundation (JDRF) is raising the alarm over FDA guidelines that could stifle the technology necessary for the development of an artificial pancreas.

comments 11 comments - Posted Dec 8, 2011

September 2011

Comments to-There Will Be a Diabetes Cure

I want to thank you all for the many comments that you have posted.   As I said in the article, it does bother me that so many promises have been made and not kept regarding a cure. This has resulted in people just giving up hope and coming to believe that there will never be a cure for diabetes.   Such promises are still being made today.

comments 20 comments - Posted Sep 13, 2011

August 2011

Bayer HealthCare Recalls 10- and 25-Count Contour Test Strip Vials in U.S. Market

US Action Follows Stop-Ship That Began in June

comments 0 comments - Posted Aug 27, 2011

July 2011

Counterfeit Diabetes Medications

The Internet allows consumers to shop for deals on anything imaginable, even prescription drugs. The economic struggles that many currently face, paired with the increasing cost of healthcare and prescription drugs, have created an environment in which counterfeit drug makers can prosper.

comments 1 comment - Posted Jul 7, 2011

June 2011

FDA Moves to Restrict Access to Three GSK Diabetes Drugs

The U.S. Food and Drug Administration has said that starting on November 18, 2011, it will restrict retail pharmacy sales of three diabetes drugs manufactured by GlaxoSmithKline: the stand-alone Avandia (rosiglitazone) and the combination drugs Avandamet (rosiglitazone and metformin) and Avandaryl (rosiglitazone and glimepiride).

comments 0 comments - Posted Jun 11, 2011

May 2011

New App Shows Which Prescriptions Can Drain Nutrients

"Nutrient Depletions" is a new smart phone app that allows users to see which of their prescription medications may be draining nutrients from their body. The app, available at iTunes stores for $1.99, works on Apple's iPhone, iTouch, and iPad products.

comments 4 comments - Posted May 31, 2011

Sanofi Says Late-Stage Trial of Type 2 Drug a Success

French drug maker Sanofi-aventis says that results from a Phase III trial of its experimental type 2 diabetes drug lixisenatide show that the drug successfully lowered patients' blood glucose levels and body weight, but did not increase the risk of hypoglycemia.

comments 0 comments - Posted May 23, 2011

April 2011

The EndoBarrier Is Approved for Sale in the EU

As we wrote back in 2008, the EndoBarrier is a very clever way to simulate the effect of a gastric bypass without the unpleasant scalpel part. It looks like a long clear plastic stocking, and it's simply threaded through the patient's mouth and stomach, down to the small intestine, where it lines the intestine's upper section (the same part that is bypassed in traditional surgery). Food slips right through it, but digestive enzymes are trapped on its other side. The two don't get to join forces until a couple of feet further downstream, so the effect on diabetes is a lot like that of a bypass: It resolves the symptoms of type 2 diabetes.

comments 0 comments - Posted Apr 1, 2011

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