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Amputations Associated With Newer Class of Diabetes Drugs

Posted by Dr. Lori Arnold

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Was the FDA too quick to approve a drug that is now showing DANGEROUS side effects through actual patient reports since the drug has been on the market? The FDA just issued a warning to patients and providers concerning a potential risk of leg and foot amputations associated with the use of the diabetes medication ‪#‎canagliflozin‬, also known as ‪INVOKANA‬ and ‪INVOKAMET‬. This drug belongs to a category of drugs used for TYPE 2 DIABETES know as SGLT2 Inhibitors (Sodium-Glucose Cotransporter-2). The drug was among several SGLT2 inhibitors to receive a label update in December 2015 after the FDA discovered that the class was linked to increased risks of ketoacidosis and urinary tract infections.  This alert was based on results from an ongoing trial, which has found that patients treated with canagliflozin are more likely to require a leg or foot amputation. Toe amputation seemed particularly more likely among canagliflozin patients.

 

Although the FDA acknowledged that further research is needed to determine whether the drug is responsible for this elevated risk, it has nevertheless encouraged patients to seek immediate medical attention if they experience symptoms such as pain or tenderness, sores or ulcers, or infections in their legs or feet. However, the agency added that patients should not stop or change their diabetes medicines without first consulting their prescriber, as doing so may lead to uncontrolled blood sugar levels, blindness, nerve and kidney damage, and heart disease.
Any adverse events observed in patients who use canagliflozin should be to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

 

Diabetes Drug Linked with Increased Risk of Amputations


Is My Medication Gluten-Free? Gluten May Be Hiding In Your Drugs…

Posted by Dr. Lori Arnold

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Is my prescription or over the counter medication ‪gluten-free‬? This is an excellent question that is often overlooked! The gluten content in our pills may be very small, but even the smallest amount could prove dangerous to the 1 in 133 Americans who suffer from Celiac Disease. In addition, depending how sensitive you are to gluten, another 18 million or more Americans have gluten sensitivities.

 
Were you even aware that your medication contained gluten as one of the “fillers”… probably NOT! Even in very, very small amounts, for someone with celiac disease, a little amount of gluten can cause
gastrointestinal upset, headache, weight loss, osteoporosis, depression, and infertility. This has been shown to have adverse effects at even 30 mg to 50 mg of gluten (about the amount in a lip balm)!

 
In 2013, Ohio State Representative Tim Ryan introduced a bill in that would require companies to disclose gluten as an ingredient in medication labels. It was reintroduced again by Rep. Ryan and New York Congressman Nita Lowey in 2015, but GovTrack.us stated that it had a 0% chance of being enacted!!! A 0% chance of being enacted, folks! Because the government does not mandate that pharmaceutical companies list gluten content on the medication label, it is left up to each individual to contact the manufacturer to find out if the product is SAFE for them.

 
It gets more complicated as the ingredient list does not list “gluten” as the ingredient, but could instead list the content under ingredients like starch…. In fact, the FDA doesn’t require products to list gluten as an allergen if the protein is found in inactive ingredients like starches or starch derivatives, or if it’s transferred in the manufacturing process. AND, the ingredients ARE NOT the same in name brand vs. generic products, therefore, you need to check on each and every pill you are on, regardless if the branded product does not contain gluten. For instance, Protonix name brand is gluten-free, however, the generic Pantoprazole manufactured by Teva is NOT gluten-free. You may need to call your health insurer to find out how to get access to a brand-name drug if the generic contains gluten.

 
Find a detailed list of gluten-free drugs found in the Top 200 drugs of 2015 at: Gluten-Free Medication List