Tuesday, September 29, 2015
Added the following:
Tresiba, a longer acting insulin was approved in late September of 2015. Basaglar, a biosimilar version of Lantus will not be sold in the U.S. until 2017,
You can learn more about the new basal insulins in these blog posts which go into the properties of each extensively:
Toujeo, a More Concentrated Version of Lantus
The Newly Approved Basal Insulin Tresiba's Label is Disappointing.
Thursday, September 17, 2015
FDA Links Invokana to Bone Fractures and Decreased Bone Mineral Density. Other Drugs in Class Suspect too.
Page Changed:SGLT2 Inhibitors, Farxiga, Invokana, Jardiance. Questionable New Drugs
Bone Fracture Risk and Decreased Bone Mineral DensityOn Sept 10, 2015, the FDA issued a Safety Alert for Invokana and Invokamet, stating that "Bone fractures have been seen in patients taking the type 2 diabetes medicine canagliflozin [Invokana].Fractures can occur as early as 12 weeks after starting canagliflozin. Canagliflozin has also been linked to decreases in bone mineral density at the hip and lower spine." Though the warning specifically mentioned Invokana, the oldest drug in this class, the warning bulletin also said "FDA is ontinuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapagliflozin (Farxiga, Xigduo XR) and empaglifozin (Jardiance, Glyxambi, Synjardy), to determine if additional label changes or studies are needed."FDA:Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral DensityNote that once your bones have become weakened, it is very hard or possibly impossible to rebuild them. This side effect probably occurs because messing with how the kidneys excrete glucose also affects how they handle the minerals used build bones: phosphorus, calcium, and magnesium. If your doctor prescribes one of these drugs, ask him or her if they are aware of these two recent FDA safety warnings. Chances are that they may have missed them.
Tuesday, June 23, 2015
In spring of 2015, a new basal insulin, Toujeo, was introduced. It is another version of the same insulin molecule found in Lantus, sold in a more concentrated form. Two other basal insulins. Tresiba and Basaglar have not yet hit the market in the U.S. though Tresiba is available in Europe and Basaglar has been approved for sale in 2016. You can learn more about the new basal insulins HERE. ...
The new basal insulins are being marketed with the claim that they last 24 hours and have an even flatter activity curve. However, given that all the well-known insulins can perform differently from what the marketing materials say they will, we will have to wait for a year or two until a significant number of users in the online diabetes community have reported on their results to know know how true this is. The new basal insulins are also being marketed, where possible, with the claim that they are less likely to cause hypos. However, the FDA has refused to let Toujeo be marketed with this claim, though the European authorities allow it.
ALSO: Deleted reference to concerns about enhanced cancer risk with Lantus as subsequent research seems to suggest this is not an issue.
Tuesday, June 9, 2015
A larger, more high profile study was published in the New England Journal of Medicine in June of 2015:Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes. Jennifer B. Green, et al. NEJM, June 8, 2015DOI: 10.1056/NEJMoa1501352 Though the focus of the study was on cardiovascular outcomes, it was also reported as stating that there was no sign of more pancreatitis or pancreatic cancer in the group that took Januvia.
Short Term Studies Can't Discover Potentially Fatal Cancers that Take A Decade to Be DetectableThere are several reasons to refute the idea that these studies prove these drugs don't cause cancer. The first study only lasted 2 years, which is far too short a time for the changes in pancreatic architecture discovered by Dr. Butler to result in overt pancreatitis. The study published in the New England Journal of Medicine study only lasted three years. But it would be quite possible to draw the same conclusion about the safety of smoking cigarettes if you limited your study to a three year period. Cancers of the pancreas take a long time to grow to where they are detectable, and by the time they are, they are almost always fatal. Pancreatic cancer is almost always symptom-free until it is too late for any treatment to keep the patient from dying within a few months.
Friday, May 15, 2015
(Note: The text below was slightly modified on 5/16 after this post was originally posted.)
Serious Side Effects of This Entire Class of DrugsThe FDA issued a warning on 5/15/2015 stating that it had received a significant number of aftermarket reports linking this class of drugs to ketoacidosis. Ketoacidosis is a very serious, potentially fatal condition where the acid level in the blood rises dangerously high. Ketoacidosis makes people very sick and if untreated can be fatal. It requries a trip to the emergency room. Symptoms of ketoacidosis include: difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.
What is particularly worrisome here is that ketoacidosis usually ONLY occurs in people with Type 1 diabetes who have very high blood sugars--those above 300 mg/dl. However, in these cases the ketoacidosis was occuring in people with Type 2 diabetes who had only modestly elevated blood sugars. It is likely that these drugs are promoting ketoacidosis because of the way they affect the kidneys, which may make it harder for the body to eliminate ketones as they build up.
Typically, people eating very low carb diets are told that as long as their blood sugar isn't high, it's perfectly safe to have raised ketone levels in blood and/or urine. But this may NOT be the case if you are taking one of these drugs because they may block the normal processes that keep ketone levels within a safe range. Until it is 100% clear what is leading to ketoacidosis in people taking these drugs it is not a good idea not to take them if you are eating a ketogenic low carb diet. You can read the entire FDA warning at:
Sunday, May 3, 2015
The home page for the Low Carb site now redirects to a page on the diabetes site too,
This will make it a lot easier for us to keep the site updated and mobile friendly.
Do let us know if you run into problems with any of these pages. We've tried to make sure all the links still work, but there are always little things we miss.
Tuesday, April 21, 2015
So we have been changing the layout of the site to make it possible to easily convert it to mobile format. The content has not changed, other than a few editorial tweaks. The process will take a few days to complete.
We hope you like the new layout!