Untreated, type 2 diabetes can lead to serious health problems, including blindness, nerve and kidney damage, and heart disease (see List of saxagliptin- and alogliptin-containing Medicines).Patients should not stop taking their medicine without first talking to their health care professionals.We evaluated two large clinical trials conducted in patients with heart disease.

The following FDA safety notices may be specifically about Tradjenta or relate to a group or class of drugs which include Tradjenta (linagliptin). May 16, 2019 - Ascend Laboratories launched an AB-rated generic version of Lupin’s Suprax (cefixime) capsules. This is an update to the FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR) issued on An official website of the United States government:

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For the latest FDA MedWatch alerts, Audience: Patient, Endocrinology, Family Practice, Internal MedicineHealthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:Audience: Gastroenterology, Endocrinology, Oncology, PatientThe Warnings and Precautions section of drug labels and patient Medication Guides for incretin mimetics contain warnings about the risk of acute pancreatitis.
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More patients randomized to the alogliptin group (106/2701, 3.9%) experienced at least one hospitalization for heart failure compared to patients randomized to placebo (89/2679, 3.3%).The results of the SAVOR and EXAMINE trials were discussed at More patients randomized to the saxagliptin group (289/8280, 3.5%) were hospitalized for heart failure compared to patients randomized to placebo (228/8212, 2.8%). Suprax ® (cefixime) – First-time generic. Available for Android and iOS devices. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. The FDA Alert(s) below may be specifically about Tradjenta or relate to a group or class of drugs which include Tradjenta (linagliptin).MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com.

We comply with the HONcode standard for trustworthy health information - FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer.Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:Gavreto (pralsetinib) is an oral selective RET kinase inhibitor for the...Detectnet (copper Cu 64 dotatate) is a radioactive diagnostic agent indicated...Onureg (azacitidine) is a nucleoside metabolic inhibitor indicated for the...Qdolo (tramadol hydrochloride) is an opioid agonist indicated in adults for ...The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Contact Us. It enrolled 5,380 patients with type 2 diabetes and established cardiovascular disease who had a recent acute coronary syndrome event (i.e., acute myocardial infarction or unstable angina requiring hospitalization). In the alogliptin trial, 3.9% of alogliptin-treated patients were hospitalized for heart failure versus 3.3% in the placebo group. Patients were followed for 1.5 years on average and up to a total of 3.4 years.

Drug Safety and Availability In a time to first event analysis, the risk of hospitalization for heart failure was significantly higher in the saxagliptin treatment group (estimated hazard ratio: 1.27; 95% confidence interval: 1.07, 1.51). We're not around right now. Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 07/01/2019: SUPPL-12: Labeling-Package Insert These clinical trials were also discussed at the We urge health care professionals and patients to report side effects involving saxagliptin, alogliptin, or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial was a large, prospective, multicenter, randomized, double-blind, placebo-controlled trial conducted in 16,492 patients with type 2 diabetes mellitus having established cardiovascular disease or at high risk of cardiovascular disease.

Saxagliptin and alogliptin are part of the class of dipeptidyl peptidase-4 (DPP-4) inhibitor drugs, which are used with diet and exercise to lower blood sugar in adults with type 2 diabetes. Select one or more newsletters to continue. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA

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