Formulary Watch |

FDA action related to medication safety and reliability, labeling, September 2007

Briefs of FDA actions related to medication safety and reliability, labeing

Current use of HRT linked to increased risk of ovarian cancer and death in 'The Million Women Study'

In the large cohort study referred to as the "The Million Women Study," the use of hormone replacement therapy (HRT) in postmenopausal women was demonstrated to increase the risk of ovarian cancer and death from ovarian cancer by 20% and 23%, respectively, compared to nonuse of HRT.

FDA action related to medication safety and reliability, September 2007

Briefs of FDA actions related to medication safety and reliability

IV bisphosphonates may cause inflammatory conditions, osteomyelitis of the jaw, facial bone or jaw surgery

In a large cohort study, it was demonstrated that the use of intravenous (IV) bisphosphonates was associated with an increased risk of inflammatory conditions or osteomyelitis of the jaw and the need for jaw or facial bone surgery.

FDA actions in brief, September 2007

Briefs of FDA actions/approvals of drugs, doses, and indications

First-time generic approvals, September 2007

First-time generic approvals: fosphenytoin for injection; pantoprazole delayed-release tablets; cefotetan for injection; cefepime for injection.

FDA pipeline preview, September 2007

The latest FDA action (through September 2007) related to satraplatin, ropinirole (Requip CR), sumatriptan/naproxen (Trexima,) desvenlafaxine (Pristiq), eprodisate (Kiacta,) raloxifene (Evista), natalizumab (Tysabri), bifeprunox, fluticasone/salmeterol inhalation powder (Advair Diskus 500/50), LX211, TZP-101, Alferminogene tadenovec, Ad5FGF-4 (Generx), tramiprosate (Alzhemed), rilonacept, aripiprazole (Abilify), sapropterin (Kuvan), oral topotecan (Hycamtin), mifepristone (Corlux), vitiligo-derived IgG (VitiGam)

Exelon patch: New formulation recently approved by FDA for the treatment of mild-to-moderate dementia of the AD type and mild-to-moderate dementia associated with PD

A new formulation for rivastigmine; a transdermal formulation of cholinesterase inhibitor approved for the treatment of mild-to-moderate dementia of the AD type and mild-to-moderate dementia associated with PD.

Privigen: New formulation recently approved by FDA for the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura

A new formulation for immune globulin intravenous (human), 10% liquid, a polyvalent human immunoglobulin G approved for the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura.

Selzentry: New molecular entity recently approved by FDA for combination antiretroviral treatment of adults with CCR5-tropic HIV-1

FDA has approved a new molecular entity for for use in combination with other antiretroviral agents for the treatment of adults with only CCR5-tropic HIV-1 who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

A note about Drug Watch

A note about Drug Watch

Drug Watch: Agents in late-stage development for the treatment of acute pain and migraine/headache (August 2007) (PDF)

Agents in late-stage development for the treatment of acute pain and migraine/headache (August 2007)

From the American Academy of Neurology 59th Annual Meeting: Sumatriptan plus naproxen reduces traditional and nontraditional migraine symptoms

Data from 2 identical double-blind phase 3 studies demonstrated that patients with migraine who were assigned to sumatriptan plus naproxen were more likely to be pain-free at 2 hours and more likely to experience relief from both traditional and nontraditional migraine symptoms compared with those assigned to placebo.

From the 67th annual scientific sessions of the American Diabetes Association: Nebivolol demonstrates neutral effect on glucose levels

Nebivolol, an investigational (NDA submitted) vasodilating beta-blocker, demonstrated a neutral effect on blood glucose levels in two 12-week clinical studies of patients with hypertension.

From the 67th annual scientific sessions of the American Diabetes Association: Pulmonary effects of inhaled insulin are small, reversible

Investigators have demonstrated that patients with type 2 diabetes who use inhaled insulin as part of their basalbolus insulin regimen experience a small decline in pulmonary function.

From the 67th annual scientific sessions of the American Diabetes Association: Exenatide associated with sustained blood glucose control, weight loss after 3 years of treatment

An open-label extension study of exenatide demonstrated sustained blood glucose control and weight loss in patients with type 2 diabetes.

From the 67th annual scientific sessions of the American Diabetes Association: Quick-release bromocriptine has favorable cardiovascular safety profile

A quick-release formulation of bromocriptine reduces the incidence of diabetic cardiovascular complications in patients with type 2 diabetes and improves glycemic control in those patients who did not achieve HbA1c <7.5% with metformin plus a sulfonylurea.

FDA advisory panel votes to keep rosiglitazone on market, but not without caveats

An FDA advisory panel voted nearly unanimously to recommend that rosiglitazone (Avandia, GlaxoSmithKline) should remain on the market despite being in overwhelming agreement that the drug increases the risk of ischemic heart disease.

Debate about rosiglitazone safety prompts hearing in House; FDA seeks to update clinical research policies

As Congress continues to work towards the reauthorization of the Prescription Drug User Fee Act (PDUFA), drug safety is once again at center stage after reports of serious cardiovascular problems associated with GlaxoSmithKline's diabetes drug rosiglitazone (Avandia).

From the 67th annual scientific sessions of the American Diabetes Association: Lipid-lowering therapies reduce development of peripheral neuropathy

Statins and fibrates reduce the risk of peripheral neuropathy in patients with type 2 diabetes independent of the agents' effects on lipids, according to results presented at the 67th annual scientific sessions of the American Diabetes Association.

From the 67th annual scientific sessions of the American Diabetes Association: PROactive: Pioglitazone improves CV outcomes in patients with renal dysfunction, type 2 diabetes, and macrovascular disease

The use of pioglitazone in patients with renal dysfunction, type 2 diabetes, and macrovascular disease can reduce the risk of death, nonfatal myocardial infarction (MI), and stroke according to results presented at the 67th annual scientific sessions of the American Diabetes Association.

From the 67th annual scientific sessions of the American Diabetes Association: Researchers debate the CV safety of rosiglitazone

Rosiglitazone did not demonstrate an increased risk of hospitalizations and death from cardiovascular causes (the composite end point) in an interim analysis of a prospective study.

Bare-metal and drug-eluting stents yield similar cardiac event risks, according to pooled analysis

A pooled analysis involving 1,748 patients in 4 randomized trials contradicts the results of recent trials that have demonstrated that the risks for death and myocardial infarction (MI) are potentially higher in patients receiving drug-eluting stents (particularlysirolimus-eluting stents) compared with patients receiving bare-metal stents.

Patients with cancer and ACS, with or without thrombocytopenia, may benefit from use of aspirin

In a small, retrospective, case-control study, it was demonstrated that aspirin (ASA) improved 7-day survival in patients with cancer who developed acute coronary syndrome (ACS), with or without thrombocytopenia.

Lamotrigine, valproate emerge as superior epilepsy treatment options as assessed in SANAD trial

The results of the Standard and New Antiepileptic Drugs (SANAD) trial, an unblinded, randomized, controlled, 2-arm study comparing the efficacy of various epilepsy drugs showed that for treatment of patients with partial seizures, lamotrigine demonstrated superior efficacy.

SOLAR: Initial rosuvastatin superior to atorvastatin, simvastatin for reaching LDL-C goals in high-risk patients

A greater percentage of patients at high risk for cardiovascular disease are likely to reach target low-density lipoprotein cholesterol (LDL-C) levels with initial treatment with rosuvastatin than with atorvastatin or simvastatin, according to the results of the Satisfying Optimal LDL-C ATP III Goals with Rosuvastatin (SOLAR) trial.

LOCSS trial: Once-daily fluticasone plus salmeterol superior to montelukast as step-down therapy for mild persistent asthma

In a multicenter, randomized, double-blind, controlled trial, investigators demonstrated that in patients whose asthma was well controlled with the use of fluticasone twice daily, switching to fluticasone plus salmeterol once daily did not increase the rates of treatment failure, but switching to montelukast once daily resulted in a 60% increased risk of treatment failure.

Budesonide plus formoterol associated with better control of persistent asthma control than gold standard therapy

In a 6-month, randomized, double-blind study, use of budesonide/formoterol as both maintenance and reliever therapy was demonstrated to provide better asthma control than either salmeterol/fluticasone plus terbutaline as needed or a fixed maintenance dose of budesonide/formoterol plus terbutaline as needed.

ADAPT: Naproxen and celecoxib demonstrated to be ineffective in primary prevention of AD

Use of naproxen or celecoxib does not prevent Alzheimer's disease (AD), at least within the early years after treatment initiation, according to a randomized, placebo-controlled, multicenter study.

HORIZON: Yearly infusion of zoledronic acid reduces risk of fracture in postmenopausal women with osteoporosis

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.