GLP-1 Type II Diabetes Mellitus: Incretin Mimetic Treatments and the FDA’s recent Re-investigation
It seems as if the past few months have been a time for concern if you are a type 2 diabetic. Controversial studies have been conducted, and subsequently released, at the University of California at Los Angeles, concerning the enduring effects of the Glucagon-like Peptide-1, more commonly known as GLP-1 “Incretin” drug treatments. Results of experiments on mice and–to a lesser extent–monkeys have sparked serious concerns. It appears that these “incretin” drugs may be linked to acute pancreatitis, scarring of the pancreas, pancreatic cancer, and some forms of Thyroid cancers.
We should, first, understand what GLP-1 drugs are and identify some of the most common varieties available. QuarterWatch–an independent publication of the Institute for Safe Medication Practices that monitors all serious adverse drug effects reported in the United States by the Food and Drug administration,–identifies GLP-1 as a hormone released from within your “gut” when you ingest food, that stimulates the release of insulin into the body. This burst of insulin “slows gastric emptying, reduces appetite, and has other effects on the regulation of blood sugar.” The GLP-1 Hormone is then rapidly “deactivated” by an enzyme, Dipeptidyl pepidase-4 (DPP-4). It is important to understand this distinction because from this seemingly tiny piece of technical information, we can understand several branches of drugs engineered to manipulate the effects of GLP-1 hormones—bringing us to the creation of several incretin mimetic drugs (drugs that mimic the actions of naturally occurring GLP-1 hormones). Sitagliptin, more commonly branded as Januvia, and Linagliptin, also known as Tradjenta, are oral medications taken to prevent the rapid breakdown of the GLP-1 hormones, theoretically allowing the hormone to regulate glucose levels more manageably as well as carry out its other designed functions. The five widely used treatments for type 2 diabetes include Exenatide (Byetta, Bydureon), Liraglutide (Victoza), Sitagliptin (Januvia), Sexagliptin (Onglyza), and Linagliptin (Tradjenta). The methods of ingestion vary among the various medications (Byetta, Bydureon, and Victoza are injected, while Januvia and Tradjenta are taken orally). According to QuarterWatch’s report released in the 3rd quarter of 2012, the current market for incretin mimetic drugs is heavily saturated by Sitagliptin (Januvia), with 11.2 million dispensed outpatient prescriptions (66%) in the year.
Despite their seemingly helpful effects, concerns began to rise about the safety of artificially releasing these stimulating hormones within the body and the possible detrimental health risks one could suffer if not completely aware. As a result of these domestic concerns, the FDA, QuarterWatch, as well as other independent research teams have taken it upon themselves to see if there is any validity to these concerns. The results were quite alarming. As indicated by the previously-cited UCLA study utilizing mice and monkeys, researchers found the size of the patients’ pancreases have dramatically increased, identifying lacerations along their surfaces, in addition to finding clear indications of acute pancreatitis. The FDA is currently re-examining the safety, labeling, and packaging of these drugs, a step that clearly indicates the risks involved when ingesting these medications.
Yet another controversy arises, this time in the realm of pharmaceutical companies and the awareness they may have had surrounding these incretin drugs and if they knowingly with-held clinical trials from the FDA in order to give these medications the best possible chance to hit the markets (thereby putting the lives of millions of people in danger).
In view of this information, I and the rest of our legal team at Aronfeld trial Lawyers would like to extend a helping hand to those in need. If you have been prescribed and have been taking any of the previously listed “incretin mimetic” drugs for Type II Diabetes Mellitus or have taken Triglitazone (Rezulin), Rosiglitazone (Avandia), or Pioglitazone (Actos) and have experienced acute pancreatitis, have developed lacerations on your pancreas, thyroid cancer, bladder cancer, or any additional ailments due to the consumption of these products, I strongly urge you to take advantage of Aronfeld Trial Lawyers’ FREE initial consultation in hopes of bringing you, your family, or a loved one the just compensation you deserve. Our office can be locally reached (in Miami, FL) by telephone at (305) 441-0440 or Toll Free at 1-866-597-4529. We look forward to hearing from you.