Three-year results of the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture Trial show that a single, annual intravenous infusion of zoledronic acid can decrease risk of vertebral fracture by 70% and the risk of hip fracture by 41% among women with osteoporosis.
Atrial fibrillation (AF) is a disorder that affects >2 million people in the United States. Firstline antiarrhythmic agents (per American College of Cardiology/American Heart Association/European Society of Cardiology guidelines) that are currently used to treat recent-onset AF work by indiscriminately blocking various ionic channels, thereby inducing a prolonged ventricular action potential duration or possibly inducing ventricular arrhythmias in the presence of myocardial ischemia because of excessive conduction slowing in diseased cardiac tissue. Vernakalant is an atrial-selective, potassium and sodium-channel-blocking agent awaiting FDA approval for the indication of conversion of recent-onset AF to normal sinus rhythm.
Andrew von Eschenbach, MD, has faced a number of tough issues since he was sworn in as FDA's commissioner in December 2006, not the least of which is drug safety. Fewer new drugs have been coming to market, and pressure continues to mount for FDA to do more with limited resources. Legislation to reauthorize user fees for pharmaceutical and medical device manufacturers has to be approved by Congress by September 30, 2007, or FDA will have to lay off hundreds of staff members. The need for speedy legislative action has focused public attention on agency operations and policies, a trend likely to continue as the nation's healthcare system and prescription drug costs become a central issue in next year's presidential elections.
Briefs of FDA actions related to medication safety and reliability (ie, boxed warnings, dear healthcare provider letters)
In a prospective, observational study, exposure to protease inhibitors (PIs) was associated with an increased risk of myocardial infarction (MI). The authors stated that this association is partly explained by dyslipidemia.
In this multicenter, randomized, open-label trial, it was demonstrated that among patients whose diabetes was not well controlled with either a sulfonylurea or metformin alone, the addition of rosiglitazone (n=2,220) did not increase the risk of cardiac-related hospitalization or death compared with patients who received metformin plus a sulfonylurea (n=2,227).
Briefs of FDA actions/approvals of drugs, doses, and indications
First-time generic approvals, August 2007
The latest FDA action (through August 2007) related to rimonabant (Zimulti), guanfacine extended-release (Intuniv), risperidone (Risperdal), maraviroc, sitaxsentan (Thelin), HCV-796, docetaxel (Taxotere Injection Concentrate), raltegravir (Isentress), topotecan (Hycamtin), ixabepilone, cetuximab (Erbitux), leukocyte interleukin (Multikine), pafuramidine, ALTU-135
Amlodipine/valsartan, a combination of calcium-channel blocker and angiotensin II receptor antagonist is now approved by FDA for the treatment of hypertension
Pregabalin, an anticonvulsant agent, is now approved by FDA for the management of fibromyalgia.
Ambrisentan, an endothelin-receptor antagonist is now approved by FDA for the treatment of PAH
W-9 form for Authors
As a result of the broad spectrum and enhanced potency of the carbapenems, this class of agents has long been held in reserve in an attempt to avoid the development of pathogen resistance to this important group of antimicrobials.
As a result of the broad spectrum and enhanced potency of the carbapenems, this class of agents has long been held in reserve in an attempt to avoid the development of pathogen resistance to this important group of antimicrobials.
First-time generic drug approval: amlodipine/benazepril capsules
A review of agents in late-stage development for the treatment of asthma (July 2007).
In a nested case-control study, the use of low-to-moderate doses of aspirin (ASA) in women was associated with a significant reduction in all-cause mortality.
New research presented at the Digestive Disease Week 2007 regarding the effect of statins on hepatitis C infection.
In the Avoiding Cardiovascular Events Through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) study, initial treatment of hypertension with a fixed-dose, dual-drug combination demonstrated "unprecedented" levels of control at 18 months.
Nebivolol is associated with long-term control of blood pressure and is as effective in obese patients as in nonobese patients with hypertension, according to the results of a 9-month extension study and a post-hoc analysis that were presented at the American Society of Hypertension 22nd Annual Scientific Meeting and Exposition.
In a randomized, controlled trial, telmisartan demonstrated a greater antiproteinuric effect than losartan in hypertensive patients with type 2 diabetes and chronic kidney disease.
Rituximab, which is currently FDA-approved for the treatment of certain B-cell lymphomas and moderate-to-severe rheumatoid arthritis, demonstrated benefit in the treatment of relapsing-remitting multiple sclerosis (RRMS) in 2 early-phase experimental trials.
Hemostatic treatment with recombinant activated factor vIIa (rFVIIa) failed to reduce death or disability in a phase 3 trial of patients with intracerebral hemorrhage (ICH), according to results presented during the AAN 59th annual meeting.
Immediate initiation of interferon beta-1b in patients with a first event suggestive of multiple sclerosis (MS) significantly reduces the risk of permanent neurologic impairment compared with delayed initiation, according to findings from the BENEFIT study presented during the AAN's 59th annual meeting.
In a large cohort study, aprotinin was not associated with an increased risk of cerebrovascular events or myocardial infarction (MI) in patients undergoing cardiothoracic surgery.
