Formulary Watch

In response to the recent FDA warnings about an increased risk of suicidal ideation/suicide attempt among children and adolescents using antidepressants, investigators performed a meta-analysis to assess the efficacy and risk associated with antidepressants among pediatric patients.

Legislation to reauthorize the Prescription Drug User Fee Act (PDUFA) IV has been expanded, as expected, via a host of provisions designed to shape drug development and ensure the safe use of medications.

Initial combination therapy with sitagliptin and metformin is more effective than either agent alone in lowering glucose values in patients with type 2 diabetes, according to the results of a recently published study.

Splitting statin tablets does not negatively affect patient satisfaction, medication adherence, or lipid level control, according to the authors of a randomized, controlled study

In a randomized, placebo-controlled trial, topiramate was demonstrated to be an effective add-on treatment to lifestyle changes in obese patients with type 2 diabetes.

Children who receive broad-spectrum antibiotics during their first year of life are at increased risk of developing childhood asthma.That was the conclusion of researchers who conducted a large, longitudinal, case-control study.

Proton-pump inhibitor (PPI) use moderately increases the risk of community-acquired pneumonia (CAP), particularly among younger patients and those who recently initiated treatment, according to the results of a population-based, case-control study.

Parkinson disease (PD) is a chronic progressive neurodegenerative disorder that affects >1 million people in the United States. PD causes both motor and nonmotor disturbances; common symptoms include resting tremor, rigidity, and bradykinesia. The current goals of treatment are to slow disease progression and to reduce disability without inducing long-term complications. The classes of agents currently approved for the treatment of PD include levodopa/carbidopa, dopamine agonists, catechol-O-methyl-transferase (COMT) inhibitors, monoamine-oxidase type B (MAO-B) inhibitors, anticholinergics, and agents/ combinations from other drug classes. Newer agents, such as rasagiline and rotigotine, offer additional treatment options to healthcare professionals. Despite these advances in the treatment of PD symptoms, current therapies do not prevent neuron degeneration. Research into new treatments is focused on neuroprotective drugs, new dopamine agonists, and nondopaminergic agents; the goal of these investigative..

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

Briefs of FDA actions related to medication safety and reliability

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.

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

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

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)

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.

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.

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

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

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.

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.

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.

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

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.

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.

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).

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.

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.