In order for a prescription pharmaceutical product like Januvia (#Januvia) to get approved for sale in the US, it needs the blessing of the FDA. The Food and Drug Administration is the regulatory authority for all food drugs entering the US. Not only do you have to prove that your medication works, but you also have to be under constant supervision to assure quality and effectiveness. As new information is acquired about side effects, it has to be reported to the FDA for review. At any time, they can change the labeling or make recommendations to your drug. These changes are published on the FDA and manufacturers websites but are not readily published in newspapers and magazines. Most consumers don’t know the updates to their medications unless informed by a pharmacy or doctor. I am going to show you where to get the latest updates.
Januvia is the trade name for Sitagliptin or Sitagliptin phosphate which is an oral anti-diabetic drug. The main purpose is the treatment of Type 2 diabetes. As you may know, Type 2 diabetes is a metabolic disorder in which you have high blood sugar and insulin resistance with a lack of insulin production. Type 2 diabetes primarily occurs as a result of obesity, genetics and lack of exercise. Your pancreas releases a peptide hormone called glucagon. The pancreas releases glucagon when the concentration of glucose in the bloodstream falls too low. Glucagon signals the liver to convert stored glycogen into glucose (sugar) and is released into your blood. Now, when there is too much glucose, insulin is released to remove glucose from the bloodstream. Januvia is a DPP-4 inhibitor which blocks glucagon from being released by your pancreas.
Over time, there will be instances where side effects change since the product will be used by more people. The side effects of Januvia have changed from when it was first approved for the US consumers till now. Sitagliptin was first approved by the FDA on October 2006. Then an oral combination of Sitagliptin and Metformin was approved in April 2007. The original side effects include stuffy or runny nose, sore throat, headaches, back, joint or muscle pain, nausea, hives, diarrhea and constipation. If used in combination with other anti-diabetic, you can experience hypoglycemia which is low blood sugar. Additional side effects include severe pain in your upper stomach spreading to your back, loss of appetite and urinating less than usual.
Since its approval, an update was added in 2015 warning of hypersensitivity reactions and a risk of severe and disabling joint pain (arthralgia and myalgia) from continued use. One of the main areas of concern were the severe allergic and skin reactions observed which include fever, sore throat, swelling in your face or tongue, burning in your eyes and skin pain. Not to mention a red or purple skin rash that spreads and causes blistering and peeling. These are not the only new side effects observed. There were instances or worsening kidney function including the need for dialysis.
Change In Label
Such changes in side effects has resulted in an update to the FDA Warning and Precaution label that is added to the prescription drug. Once the Januvia generic is available (2017-2018), don’t expect the label or warning to go away. The label stays with the active ingredient regardless of the new manufacturer or the replacement Januvia cost. Most patients will rely on your doctor to read the medical insert in the link below.
This insert has all the recent information and must be included with every prescription drug box, bottle or blister package. Depending on how your prescription is filled, most pharmacies will remove the insert or leave one if several bottles are prescribed. Patients are not expected to know all the information nor are the doctors. This medical insert is a point of reference when questions arise. For me, it’s a good starting point to determine if a side effect I am experiencing was listed. It’s kind of a forecast into what side effects you can experience. If you experience a new symptom, contact your doctor.
You can also go to the above link to check medical updates of recent prescription drug warnings. It is the FDA gateway for clinically important safety information and reporting serious problems with human medical products. Anyone can report an issue. There are different forms designed for doctors and patients. The more information available, the better chance of determining if something went wrong.
Have you used Januvia safely?