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Weekly Drug News Round-Up: December 27, 2017

FDA Clears Giapreza for Dangerous Low Blood Pressure

In shock, blood pressure drops so low that the brain, kidneys and other vital organs don’t received adequate blood flow Read More…

The FDA has approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. Giapreza, from La Jolla Pharmaceutical, is a synthetic human angiotensin II vasoconstrictor. In studies of 321 patients with shock and a critically low blood pressure, significantly more patients responded to treatment with Giapreza compared to placebo. Giapreza effectively increased blood pressure when added to conventional treatments (fluid and vasopressor therapy such as catecholamines and/or vasopressin) used to raise blood pressure. Giapreza can cause dangerous blood clots with serious consequences; prophylactic treatment for blood clots should be used.

Asthma-Related Death Boxed Warning Removed from Combo Inhalers

The Boxed Warning, the most prominent warning, about asthma-related death has been removed from these drug labels Read More...

In 2011, the FDA required that drug companies that market long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) conduct trials to evaluate the safety of these agents. After review of four large studies, the FDA has determined that treating asthma with ICS/LABA does not result in significantly more serious asthma-related side effects than treatment with ICS alone. Four trials also assessed efficacy of the ICS/LABA products, and demonstrated that the ICS/LABA combination reduced asthma exacerbations compared to ICS alone. Using LABAs alone without an ICS for asthma is linked with an increased risk of asthma-related death and this Boxed Warning will remain on single ingredient LABA medicine. Labels on combo inhalers such as Advair, Breo Ellipta, Dulera, AirDuo, and Symbicort will be updated.

Prexxartan Approved as First Oral Liquid for Valsartan in U.S.

Valsartan was first FDA-approved in 2001 as Diovan

The FDA has approved Medicure's  Prexxartan (valsartan), an angiotensin II receptor blocker (ARB) oral solution indicated for the treatment of hypertension (high blood pressure), heart failure, and left ventricular dysfunction following myocardial infarction (heart attack). The FDA approval of Prexxartan makes it the first approved oral liquid dosage form of the angiotensin II receptor blocker (ARB) valsartan in the U.S. Prexxartan is expected to launch into the marketplace during the first half of 2018. Valsartan is also available in a brand (Diovan) and generic tablet formulation, too.

Omidria Use Expanded for Pediatric Patients

Omidria also is the only NSAID-containing product FDA-approved for intraocular use Read More...

Omidria (ketorolac and phenylephrine), originally approved in 2014, is an anti-inflammatory and mydriatic combination added to irrigation solution during cataract surgery and intraocular lens replacement procedures. Omidria prevents intraoperative miosis (pupil constriction) and reduces postoperative pain. The FDA has now expanded the approved use to include pediatric patients (ages birth through 17 years old). Success in this patient population was demonstrated in a clinical study with 78 pediatric patients randomized to either Omidria or phenylephrine administered intraoperatively. Omeros Corporation has now gained an added six-month extension of market exclusivity with Omidria.

FDA Alert: New Class Warning for Gadolinium-Based Contrast Agents

Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function Read More...

Gadolinium-based contrast agents (GBCAs) are used with medical imaging devices called magnetic resonance imaging (MRI) scanners to examine the body for problems such as cancer, infections, or bleeding. Gadolinium, a heavy metal, may remain in the body and brain for months to years. The FDA is now requiring safety updates and a new class warning for all GBCAs for MRI. To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that may occur with pre-existing kidney failure. FDA also received reports of adverse events involving multiple organ systems in patients with normal kidney function., but a causal association has not been established.