Epocrates Drug Updates - Editor's Pick
May 22, 2015
FDA MedWatch Safety Alert: Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors
The FDA recently warned that the type 2 diabetes medications canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis and result in hospitalization. In postmarketing reports, there was a temporal association between initiation of an SGLT2 inhibitor and diabetic ketoacidosis, ketoacidosis, or ketosis. The median time between starting an SGLT2 inhibitor and onset of ketoacidosis was 2 weeks. The FDA is investigating this safety issue and advises providers to evaluate for the presence of ketoacidosis in patients experiencing any signs or symptoms. If ketoacidosis is confirmed, discontinue the SGLT2 inhibitor, correct the acidosis, and monitor glucose levels.
Noteworthy Recent Updates
May 15, 2015
First-Time Generic for Abilify Tablets
The FDA recently approved aripiprazole, the first-time generic for Abilify. Generic aripiprazole—an atypical antipsychotic used for conditions including, but not limited to, schizophrenia and bipolar I disorder—is now available as an oral tablet in strengths of 2, 5, 10, 15, 20, and 30 mg. The exact mechanism of action is unknown, but involves being a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, and an antagonist at serotonin 5-HT2A receptors.
May 15, 2015
Corlanor Approved for Stable, Symptomatic Chronic Heart Failure
The FDA recently approved Corlanor (ivabradine), a novel drug therapy for treating chronic heart failure patients. It is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that decreases HR by selectively inhibiting cardiac pacemaker current in the SA node. Corlanor is indicated for stable, symptomatic chronic heart failure patients with an LVEF less than or equal to 35% and a resting HR of at least 70 bpm. Dosing is adjusted to maintain a resting HR of 50-60 bpm.
May 8, 2015
Cyramza Now Approved for Metastatic Colon Cancer
The FDA recently approved Cyramza (ramucirumab) in combination with chemotherapy (FOLFIRI regimen) for the treatment of metastatic colorectal cancer that has progressed following a regimen of bevacizumab, oxaliplatin, and a fluoropyrimidine. Cyramza is given as an IV infusion every 2 weeks on the same day as FOLFIRI. Cyramza should be held before and around the time of surgery due to impaired wound healing risk, which is now included in the black box warning along with GI perforation and hemorrhage. Also of note, thyroid function should be monitored during treatment.
May 8, 2015
Avycaz Approved for Complicated Bacterial Infections
The FDA has given Avycaz (ceftazidime/avibactam) its seal of approval for the treatment of complicated intra-abdominal infections in combination with metronidazole, as well as for complicated UTIs including pyelonephritis. Ceftazidime is a 3rd-generation anti-pseudomonal cephalosporin, and avibactam is a novel beta-lactamase inhibitor that prevents microbial resistance. Avycaz is available only as an IV infusion, and the dose must be adjusted according to renal function. Unfortunately, it is not active against MRSA.
April 13, 2015
FDA MedWatch Safety Alert: Feraheme
A new Boxed Warning about the risk of serious, potentially fatal allergic reactions has been added to the Feraheme (ferumoxytol) label. Feraheme is also now contraindicated in all patients with a history of hypersensitivity to any IV iron replacement product. IV iron products should only be given if required, as all IV iron replacement products carry the risk of potentially life-threatening hypersensitivity reactions. Feraheme must be diluted and administered as an IV infusion over at least 15 minutes. Patients receiving Feraheme should be monitored for hypersensitivity signs and symptoms during and for at least 30 minutes after infusion.
Black Box Warning for Feraheme
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