- Janumet®(as a combination product containing Metformin, Sitagliptin)
- Juvisync®(as a combination product containing Simvastatin, Sitagliptin)
[Posted 03/14/2013]ISSUE:FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics.
BACKGROUND:Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
RECOMMENDATIONS:FDA has not reached any new conclusions about safety risks with incretin mimetic drugs. This early communication is intended only to inform the public and health care professionals that the Agency intends to obtain and evaluate this new information. FDA will participate in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Cancer Institute's (NCI) Workshop on Pancreatitis-Diabetes-Pancreatic Cancer in June 2013 to gather and share additional information. FDA will communicate its final conclusions and recommendations when its review is complete or when the Agency has additional information to report.
The Warnings and Precautions section of drug labels and patient Medication Guides for incretin mimetics contain warnings about the risk of acute pancreatitis. FDA has not previously communicated about the potential risk of pre-cancerous findings of the pancreas with incretin mimetics. FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer.
At this time, patients should continue to take their medicine as directed until they talk to their health care professional, and health care professionals should continue to follow the prescribing recommendations in the drug labels.For more information visit the FDA website at: Web Siteand Web Site.
Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Sitagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amounts of certain natural substances that lower blood sugar when it is high.
Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.
Sitagliptin comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take sitagliptin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sitagliptin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Sitagliptin helps to control high blood sugar but does not cure diabetes. Continue to take sitagliptin even if you feel well. Do not stop taking sitagliptin without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking sitagliptin,
- tell your doctor and pharmacist if you are allergic to sitagliptin or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: digoxin (Lanoxicaps, Lanoxin); insulin; and certain oral medications for diabetes including acetohexamide, chlorpropamide (Diabinese), glimepiride (Amaryl), glipizide (Glucotrol, in Metaglip), glyburide (Diabeta, Glycron, Micronase), tolazamide (Tolinase), and tolbutamide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had diabetes , diabetic ketoacidosis (a serious condition that may occur when blood sugar is too high), pancreatitis (swelling of the pancreas), gallstones, high levels of triglycerides (fatty substances) in your blood, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking sitagliptin, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sitagliptin.
- talk to your doctor about what you should do if you get hurt or if you develop a fever or infection. These conditions may affect your blood sugar.
- talk to your doctor about the symptoms of high and low blood sugar and other complications of diabetes, what to do if you develop these symptoms, and how to prevent these conditions.
Be sure to follow all diet and exercise recommendations made by your doctor or dietician.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Sitagliptin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stuffed or runny nose
- sore throat
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- ongoing pain, that begins in the upper left or middle of the stomach but may spread to the back
- loss of appetite
Sitagliptin may cause severe or life-threatening inflammation of the pancreas. Talk to your doctor about the risks of taking this medication.
Sitagliptin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to sitagliptin. Your doctor will also tell you how to check your response to sitagliptin by measuring your blood or urine sugar levels at home. Follow these instructions carefully.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: February 15, 2014.