The US Food and Drug Administration (FDA) on Tuesday updated its safety communication for Type 2 diabetes medicines containing saxagliptin and alogliptin as they may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. FDA has added new warnings to the following drug labels about this safety issue: AstraZeneca’s Onglyza (saxagliptin) AstraZeneca’s Kombiglyze XR (saxagliptin and metformin extended release) Takeda’...

The US Food and Drug Administration (FDA) is not consistent with its use of surrogate endpoints in assessing the risks and benefits of treatments for some diseases, making it difficult to assess the treatments' actual clinical effects on outcomes important to patients, according to researchers from Johns Hopkins. The researchers came to this conclusion after evaluating 58 FDA drugs approved between 2003 and 2012 for chronic obstructive pulmonary disease (COPD), Type 1 an...

The US Food and Drug Administration (FDA) said it will require manufacturers of multi-dose diabetes pen devices to label their products with more prominent warnings that patients should not share the devices. In a 25 February 2015 safety announcement, FDA said the new warnings are meant to "reduce the serious risk of infection" when users share insulin pens and other injectable diabetes medications, "even [when] the needle is changed." "Sharing pens can result in the sp...

India’s Central Drugs Standard Control Organization (CDSCO) is looking to tighten the regulation of blood glucose testing supplies, it announced last week. In a 7 August 2014 notice issued to all local State Drugs Controllers and port authorities, CDSCO ordered that importers and manufacturers of blood glucose test strips and analyzer based glucose reagents must provide three batches for testing at the National Institute of Biologicals in Noida.  Following the testin...

US pharmaceutical regulators at the Food and Drug Administration (FDA) easily best their EU counterparts at the European Medicines Agency (EMA) when it comes to approving new diabetes treatments, a new report claims. The report, issued on 7 July 2014 by the regulatory consulting group Context Matters, looked at a study issued earlier this year in the New England Journal of Medicine (NEJM) which compared new drug approvals by FDA, EMA and Health Canada...

The US Food and Drug Administration (FDA) announced Tuesday that it is initiating an investigation into the safety of saxagliptin, a diabetes drug, and its association with heart failure. Background Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, and is marketed under the trade names Onglyza and Kombiglyze XR (saxagliptin and metformin) by Bristol-Myers Squibb (BMS), its manufacturer, and AstraZeneca. The drugs are FDA-approved as an adjunct to diet and exe...

US regulators have released two extensive draft guidance documents intended to help the medical device industry with the development of blood glucose devices for both home and prescription use. Background Devices used to monitor blood glucose levels are used by millions of Americans with diabetes. While FDA has traditionally not observed a significant regulatory distinction between devices with prescription and non-prescription uses, it now says one is needed in light o...

Diabetes drugs of the GLP-1 and DPP-4 class have recently come under intense scrutiny by regulators on both sides of the Atlantic Ocean, with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) expressing strong concerns that the pancreatic risks associated with the drug might well outweigh their benefits. Now, however, EU regulators have reaffirmed their positive benefit-risk assessment, saying that no new concerns could be identified b...

The US Food and Drug Administration (FDA) seems to be on a major kick against unapproved and misbranded diabetes drug products, according to the most recent batch of Warning Letters released on 23 July 2013. Start of a Crackdown FDA often uses batches of Warning Letters to make an enforcement point against practices it does not favor. Rather than releasing 10 Warning Letters over 10 weeks, it may concentrate them all into a single week in the hopes of making a statement...

In draft guidance published today, the UK's National Institute for Health and Care Excellence (NICE) recommends Alimera's Iluvien for certain patients with chronic diabetic macular edema after the company offered a price cut for its treatment. NICE is specifically recommending Iluvien, a fluocinolone acetonide intravitreal implant, in patients with chronic diabetic macular edema who are considered insufficiently responsive to other available therapies, as well as thos...

A class of diabetes drug taken by millions of patients around the world may be considerably more dangerous than originally though, owing to the reticence of pharmaceutical companies to share data and make public the results of some of their studies, claim investigators with the British Medical Journal . Background The class of drugs, known as glucagon-like peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors, have already been the subject of ongoing ...

US regulatory officials have announced the approval of Johnson & Johnson's new type 2 diabetes product, Invokana (canaglifilozin)-the first sodium-glucose co-transporter 2 (SGLT2) inhibitor approved by the agency. "Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors," said Mary Parks, director of the Division of Metabolism and Endocrinology Products (DMEP)at FDA's Center for Drug Evalua...