Tuesday, June 23, 2015
New Basal Insulins Introduced
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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 new high profile study that claims to show Januvia is completely safe, does not
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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 Detectable
There 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
FDA Issues Letter Warning of Ketoacidosis Associated with Whole Class of SGLT-2 Inhibitor Drugs
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(Note: The text below was slightly modified on 5/16 after this post was originally posted.)
Serious Side Effects of This Entire Class of Drugs
The 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
We've Consolidated our Diabetes and Low Carb Web Sites
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
We're Changing the Look of our Site to Make it More Mobile Friendly
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!
Friday, April 17, 2015
FDA to add warning to Onglyza label warning of greatly increased risk of heart failure
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In April of 2015, the data was made public that the SAVOR study showed that people taking Onglyza were 27% more likely to be hospitalized for heart failure. As a result, the FDA decided to add warning information about heart failure to the Onglyza label. (Details HERE.) However, few doctors keep up with changes to the labels of the drugs they prescribe. And as the FDA still considers this to be an acceptable drug, it will continue to be prescribed. This kind of FDA response is in line with its policy of putting the interests drug companies above those of drug users.