Patients using the diabetes drugs Farxiga and Jardiance had twice the risk for lower limb amputations relative to certain other diabetes medicines, according to a new observational study published in November 2018 by The BMJ medical journal in. However, in the US only a third diabetes drugs in the sodium-glucose cotransporter 2 (SGLT2) … [Read more...]
Fournier’s Gangrene: Side Effect For Invokana, Farxiga, And Jardiance
From this August 29, 2018 Drug Safety Communication, “FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes”, we get the following details about this new safety issue for Invokana, Farxiga, Jardiance, and similar diabetes drugs: Fournier’s gangrene is an extremely rare but life-threatening … [Read more...]
Increased Risks Of Lower-Limb Amputations For Farxiga And Jardiance
During late August a presentation at the 2018 European Society of Cardiology Congress in Munich, Germany included evidence that the SGLT-2 inhibitors Invokana, Jardiance, and Farxiga all are associated with twofold increases for lower-limb amputations when compared to GLP-1 receptor agonists diabetes drugs. An August 25, 2018 Healio.com article, … [Read more...]
Health Canada: OFEV Label Will Add Drug-Induced Liver Injury Warning
On January 11, 2018 Health Canada issued a Dear Healthcare Professional Letter communication titled “OFEV (nintedanib) – Risk of Drug-Induced Liver Injury and the Need for Regular Monitoring of Liver Function”. From the Background Information section of that new Health Canada document we get this overview of the safety issue: OFEV (nintedanib) … [Read more...]
2017 Medical Articles: Association Of Melanoma With Viagra And Cialis
The five brand name erectile dysfunction (ED) drugs in the phosphodiesterase 5 (PDE-5) inhibitors class are Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil), Staxyn (vardenafil), and Stendra (avanafil). Cialis is also prescribed sometimes when doctors see the signs and symptoms of benign prostatic hyperplasia (BPH). Two other … [Read more...]
Keytruda / Opdivo / Yervoy: May Cause Vision Loss, Retinal Detachment
A developing drug safety issue is presented in this news report, “FDA Considers Label Changes for Keytruda, Opdivo and Yervoy”, which was posted July 12, 2017 on the Regulatory Affairs Professional Society (RAPS) website. Here are some contextual details provided by reporter Zachary Brennan in this article: The consideration for changing the … [Read more...]
No Warning Added By FDA To Drug Label For Actemra About Pancreatitis
An insightful article by reported Charles Piller, “Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients”, published June 5, 2017 online by STAT, put the spotlight on some serious but little-known side effects associated with this medicine from Genentech, Inc. From that recent article we get this rather … [Read more...]
New Anticoagulant BevyxXa Approved by the FDA
On June 23, 2017, a new anticoagulant drug called BevyxXa (betrixaban) was approved by the FDA for the prevention of venous thromboembolism and pulmonary embolism. This drug acts as a direct Factor Xa inhibitor, similar to the other anticoagulant drugs Eliquis, Savaysa, and Xarelto. Unlike the anticoagulant Pradaxa, which is a direct … [Read more...]
FDA Concern About Whether Victoza Is Associated With Pancreatic Cancer
In advance of the June 20, 2017 FDA Advisory Committee meeting to discuss Novo Nordisk’s supplemental New Drug Application (sNDA) for approval of Victoza® (liraglutide) injection, we reviewed the FDA Briefing Document for this Endocrinologic and Metabolic Drugs Advisory Committee Meeting (EMDAC), which includes a section titled “ONCOLOGY CONSULT: … [Read more...]
Ocrevus Patient Gets Progressive Multifocal Leukoencephalopathy (PML)
A May 24, 2017 Reuters news report, “Deadly brain infection in German MS patient prompts Roche investigation”, brings some unwanted attention to a potential drug safety issue for Ocrevus (ocrelizumab injection) which may negatively affect this projected sales success. From this recent Reuters article: A person in Germany treated with Roche Holding … [Read more...]