FDA's first active medical product surveillance eyes antidiabetic-MI link

Thompson, Cheryl A.
April 2011
American Journal of Health-System Pharmacy;4/1/2011, Vol. 68 Issue 7, p550
Academic Journal
The article reports that Food and Drug Administration's (FDA's) first electronic active surveillance system will be used to gauge the risk of myocardial infarction (MI) in type 2 diabetes patients using saxagliptin. The analysis will be conducted ahead of a Phase IV study sponsored by Bristol-Myers Squibb, and will conclude in June 2013. The article mentions that the surveillance system was developed as part of FDA's Mini-Sentinel program to identify and evaluate safety issues in medical products.


Related Articles

  • ROSIGLITAZONEA JOURNEY THAT NEVER COMPLETED. Gopala, Anjali; Sharma, Vinek Kumar; Ganti, Subrahmanya Sarma // International Journal of Pharmacy & Pharmaceutical Sciences;2010 Supplement 2, Vol. 2 Issue S2, p7 

    Diabetes is the major cause of mortality and morbidity leading to cardiovascular and other related complications. Peroxisome proliferator activated receptors (PPARs) are ligand-activated transcription factors of nuclear hormone receptor super family comprising of three subtypes such as PPARα,...

  • Rosiglitazone use and associated adverse event rates in Canada: an updated analysis. Iczkovitz, Sandra; Dhalla, Daniella; Ross Terres, Jorge A. // BMC Research Notes;9/30/2015, Vol. 8 Issue 1, p1 

    Background: We previously reported on the change in the use of rosiglitazone-containing products (RCP) and adverse event reporting rates in Canadian patients between 2004 and 2010. The present study extends this analysis to include the January 2011 to December 2012 time period. Methods: RCP...

  • Adverse cardiovascular outcomes between insulin-treated and non-insulin treated diabetic patients after percutaneous coronary intervention: a systematic review and meta-analysis. Bundhun, Pravesh Kumar; Nuo Li; Meng-Hua Chen // Cardiovascular Diabetology;10/8/2015, Vol. 14 Issue 1, p1 

    Background: Type 2 diabetes mellitus (DM) patients have worse adverse cardiovascular outcomes after Percutaneous Coronary Intervention (PCI). However, the adverse cardiovascular outcomes between insulin-treated and noninsulin treated DM patients have been a subject of debate. We sought to...

  • Sweet Nothings. Jacobson, Michael F. // Nutrition Action Health Letter;Mar2013, Vol. 40 Issue 2, p2 

    The article reports on the harm done by large amounts of added sugars on people. High consumption of more sugary drinks is linked to a higher risk of weight gain, diabetes, heart disease, and gout. Women are advised to consume no more than six teaspoons of added sugar a day. Companies are...

  • Erratum to: Linagliptin: a review of its use in the management of type 2 diabetes mellitus. Deeks, Emma D. // Drugs;2013, Vol. 73 Issue 1, p99 

    No abstract available.

  • Drugs in Phase 3 Clinical Trials for Type 2 Diabetes. Goodman, Alice // American Health & Drug Benefits;Sep2011, Vol. 4 Issue 6, p410 

    The article reports on novel therapies, including dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors, that are either being evaluated in 2011 in clinical trials for type two diabetes or have been approved to treat type two...

  • Metformin Makes Headline News. FALOON, WILLIAM // Life Extension;Nov2012, Vol. 18 Issue 11, p7 

    The author discusses the therapeutic use of the diabetes II drug metformin, focusing on the reluctance of the U.S. Food & Drug Administration to approve the drug or allow its use in the treatment or prevention of cancer or cardiovascular disease. Metformin lowers blood glucose levels and excess...

  • FDA approved expanded indication for exenatide.  // Hem/Onc Today;12/10/2009, Vol. 10 Issue 23, p74 

    The article reports on the approval by the U.S. Food and Drug Administration (FDA) in December 2009 for exenatide injection for use as monotherapy in patients with type 2 diabetes.

  • Bydureon takes on diabetes. DEARMENT, ALARIC // Drug Store News;3/12/2014, Vol. 34 Issue 4, p44 

    The article reports on the approval of the drug Bydureon by the U.S. Food and Drug Administration (FDA) for the treatment of Type 2 diabetes.


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics