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Recent Updates
Apr 26, 2012
MedWatch Safety Alert for Aliskiren-Containing Medications
The FDA recently issued new warnings and contraindications for the renin inhibitor, aliskiren, when used alone (Tekturna) or in combination as aliskiren/amlodipine/hydrochlorothiazide (Amturnide), aliskiren/amlodipine (Tekamlo), aliskiren/hydrochlorothiazide (Tekturna HCT), or aliskiren/valsartan (Valturna). Use of aliskiren-containing medications with angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) may increase the risk of renal impairment, hypotension, and hyperkalemia. These drug combinations are contraindicated in patients with diabetes and should be avoided in patients with moderate to severe renal impairment (glomerular filtration rate (GFR) less than 60 mL/min). The aliskiren/valsartan combination, Valturna, will no longer be marketed after July 2012. MedWatch Safety Alert for Aliskiren-Containing Medications
Apr 26, 2012
New Drug Monograph for Voraxaze
The FDA recently approved Voraxaze (glucarpidase) to treat methotrexate toxicity in patients with moderate to severe renal impairment who are receiving high-dose methotrexate therapy. Glucarpidase is a recombinant bacterial enzyme that converts methotrexate to inactive metabolites. New Drug Monograph for Voraxaze
Apr 19, 2012
New Generic Drug Monographs
Four new first-time generic formulations recently launched: 1) HMG-CoA reductase inhibitor, fluvastatin (generic for Lescol), to treat dyslipidemias in patients greater than 10 years old; 2) angiotensin II receptor blocker (ARB), irbesartan (generic for Avapro), to treat hypertension and diabetic nephropathy in adults; 3) ARB/thiazide diuretic combination, irbesartan/hydrochlorothiazide (generic for Avalide) to treat hypertension in adults; and 4) modafinil (generic for Provigil) to treat narcolepsy and somnolence in adult patients. fluvastatin , irbesartan , irbesartan/hydrochlorothiazide , modafinil
Apr 05, 2012
MedWatch Safety Alert for Celexa
The FDA issued an alert to clarify dosing and warning recommendations for the selective serotonin reuptake inhibitor (SSRI), Celexa (citalopram). Citalopram has been associated with QT prolongation and Torsade de Pointes, particularly at high doses. The drug is not recommended at doses greater than 40 mg per day. Citalopram is not recommended for patients with an increased risk of QT prolongation (congenital long QT syndrome, bradycardia, electrolyte abnormalities, recent acute MI, uncompensated heart failure, or concomitant drugs that prolong the QT interval). Patients with hepatic impairment, patients greater than 60 years old, and patients who are poor CYP2C19 metabolizers or taking CYP2C19 inhibitor drugs (i.e. cimetidine) should not exceed 20 mg per day of citalopram. MedWatch Safety Alert for Celexa
Mar 29, 2012
New Drug Monograph for Zioptan
The FDA recently approved the prostaglandin analog, Zioptan (tafluprost ophthalmic), to treat elevated intraocular pressure associated with open-angle glaucoma or ocular hypertension in adult patients. New Drug Monograph for Zioptan
Mar 29, 2012
New Generic Drug Monograph for Ibandronate
The FDA recently approved the oral formulation of ibandronate (generic for Boniva), administered once-monthly for the prevention and treatment of postmenopausal osteoporosis in adult female patients. New Generic Drug Monograph for Ibandronate
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New Drug Monographs
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