Victoza, Januvia, and Other Diabetes Drugs Under FDA Scrutiny: Marketing's "Ethical Concerns"
"Facing growing evidence that some of America's top-selling diabetes medicines could lead to pancreatic disease, federal regulators [see FDA notice here] on Thursday opened an unusual review of drugs from Merck & Co., Bristol-Myers Squibb Co. and other pharmaceutical makers," reports the Wall Street Journal (here).Some of the "evidence" may have come from Public Citizen in a petition it filed in 2010 with the Food and Drug Administration (FDA). That petition called on the agency to "immediately remove from the market the increasingly prescribed diabetes drug Victoza because it puts patients at higher risk of thyroid ca...
Source: Pharma Marketing Blog - March 15, 2013 Category: Pharma Commentators Tags: Drug Safety Victoza FDA Avandia Januvia Paula Deen Ethics diabetes Source Type: blogs

March Diabetes News Snippet Post
Here are all the news items posted in March: Jennysaid... People taking Byetta, Victoza, Januvia, and Onglyza had less heart failure than those not on these drugs. http://www.sciencedaily.com/releases/2013/03/130310164109.htmHowever, it is likely this is because Avandia and Actos CAUSE heart failure, rather than that these other drugs prevent it. People are rarely put on both families of drugs at once. It may also be because these GLP-1 related drugs are mostly prescribed to affluent, younger people with diabetes and good health insurance, while poorer people are put on the cheap sulfonylurea drugs which are now known to ...
Source: Diabetes Update - March 11, 2013 Category: Diabetes Authors: Jenny Source Type: blogs

From Abby: Do You Have What It Takes?
Abby is an RN, a PWD, and en route to becoming a CDE.  (Her last name will eventually snap off due to all of the accompanying letters.)  As she's worked through her schooling and now her experience in the field, her scope of what she's learned through life with diabetes as a patient and what she's learned through school and experience as a nurse are very different, and both play a rule in her pursuit of a CDE certification.  *   *   *My goal when applying to nursing school in 2009 was simple: become a Certified Diabetes Educator. I wanted NOTHING to do with nursing, and I for sure did not...
Source: Six Until Me. - March 1, 2013 Category: Diabetes Tags: From Abby Source Type: blogs

Pancreatitis Risks And A Pair Of Diabetes Drug
Yet another potentially worrisome sign for a pair of widely used diabetes drugs. A new study indicates that Merck’ Januvia and Bristol-Myers Squibb’s as Byetta can double the risk of developing pancreatitis, which is an inflammation of the pancreas that is linked to cancer and kidney failure. This is the same issue that has plagued both drugs over the past few years. The study, which examined insurance records for more than 2,500 diabetics between February 2005 and December 2008, found that patients hospitalized with pancreatitis were twice as likely to be taking either of the drugs than a control group of Type...
Source: Pharmalot - February 26, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Bristol Myers Squibb Byetta Diabetes Eli Lilly Januvia Merck Novo Nordisk Victoza Source Type: blogs

Another Dangerously Misinterpreted Study: Insulin Doesn't Raise Cancer & Heart Disese Risk--High Blood Sugars Do
A huge, long-term UK study appears to show that for people with Type 2 Diabetes injecting insulin raises the risk of both cancer and heart disease.The study is:Mortality and Other Important Diabetes-Related Outcomes With Insulin vs Other Antihyperglycemic Therapies in Type 2 DiabetesCraig J. Currie et al.  The Journal of Clinical Endocrinology & Metabolism February 1, 2013 vol. 98 no. 2 668-677The study examined the records of 84,622 people with Type 2 Diabetes treated with 5 different drug combinations. It concludes: " In people with T2DM, exogenous insulin therapy was associated with an increased risk of diab...
Source: Diabetes Update - February 21, 2013 Category: Diabetes Authors: Jenny Source Type: blogs

More on Merck
Merck settles lawsuits over cholesterol drug for $688 million Merck & Co. has agreed to pay $688 million to settle two long-running lawsuits brought by investors who alleged the drugmaker delayed releasing bad news on its blockbuster cholesterol drugs to prevent a drop in sales. Merck, the world’s third biggest drugmaker by revenue, said yesterday that it agreed to the settlement because it’s in the best interest of the company and current shareholders. It is taking a charge of nearly a half-billion dollars against 2012 earnings. The delay in releasing results of a study that was meant to bolster sales of pricey chol...
Source: PharmaGossip - February 14, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Three New Drugs for Type 2 Diabetes Approved
By Diane Fennell On January 26, pharmaceutical manufacturer Takeda announced the approval of its Type 2 diabetes drug, Nesina (generic name alogliptin) by the US Food and Drug Administration (FDA). It is the fourth drug in a class of medicines known as DPP-4 inhibitors, joining Januvia (saxagliptin), Onglyza (sitagliptin), and Tradjenta (linagliptin). Approved simultaneously with Nesina were the drugs Kazano (alogliptin and metformin) and Oseni (alogliptin and pioglitazone [brand name Actos]). DPP-4 inhibitors work to lower blood glucose by blocking the action of an enzyme known as dipeptidyl peptidase 4, or DPP-4. DPP-...
Source: Diabetes Self-Management - February 8, 2013 Category: Diabetes Authors: Diane Fennell Source Type: blogs

A New J&J Diabetes Pill, Heart Risks & FDA Approval
Another horse race is under way in the diabetes market and Johnson & Johnson is hoping to become the first entrant to sell a treatment known as a SGLT2 inhibitor. The question is whether an unclear cardiovascular risk will prompt the FDA to await final results of a key study, which would delay J&J from selling its drug and intensify the battle. In advance of an FDA advisory committee meeting this week, agency medical reviewers released a briefing document that noted a concern of high major adverse cardiovascular events during the first 30 days after taking J&J’s canagliflozin in its CANVAS cardiovascul...
Source: Pharmalot - January 8, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized AstraZeneca Avandia Boehringer Ingelheim Bristol Myers Squibb Diabetes Eli Lilly FDA GlaxoSmithKline Januvia JJ Johnson & Johnson Merck Type 2 Diabetes Source Type: blogs

The State of Januvia (and its Election Ties)
Again, Januvia is one of the most searched-for terms on this site - which is interesting, because it's an oral drug for controlling Type 2 diabetes with which I have no personal experience.   But there's a "perfect storm" surrounding Januvia that e... (Source: Diabetes Mine)
Source: Diabetes Mine - November 4, 2008 Category: Endocrinology Authors: Amy Tenderich Source Type: blogs

The State of Januvia (and its Election Ties)
Again, Januvia is one of the most searched-for terms on this site - which is interesting, because it's an oral drug for controlling Type 2 diabetes with which I have no personal experience.  But there's a "perfect storm" surrounding Januvia that e... (Source: Diabetes Mine)
Source: Diabetes Mine - November 4, 2008 Category: Endocrinology Authors: Amy Tenderich Source Type: blogs

Januvia Smackdown
Get your ringside seats, Folks! A while back I posted about the Merck's new Type 2 oral drug Januvia (What It Doesn't Do), explaining how it apparently trumps competitors in terms of patient "tolerability." No other post has ever generated such ... (Source: Diabetes Mine)
Source: Diabetes Mine - August 16, 2007 Category: Endocrinology Authors: Amy Tenderich Source Type: blogs

Januvia: Is It "Oral Byetta" or Just a Lucky Break?
I noticed a lot of comment action recently on a previous post about Januvia. I guess more and more people have now tried Merck's new type 2 "Wonder Drug" and want to share their experiences, good and bad. Some are delighted with the glucose cont... (Source: Diabetes Mine)
Source: Diabetes Mine - May 9, 2007 Category: Endocrinology Authors: Amy Tenderich Source Type: blogs

Much Ado About Januvia: What It Doesn't Do
Lots of press recently about Merck's brand spankin' new Type 2 diabetes drug, Januvia. Patients seem to like it. The EU likes it. So Wall Street likes it, too. What is so wonderful about this new oral with the Shakespearean name?Here's what I fou... (Source: Diabetes Mine)
Source: Diabetes Mine - February 6, 2007 Category: Endocrinology Authors: Amy Tenderich Source Type: blogs