Formulary Watch |

Surgery and therapy improve type 2 diabetes, results show

Bariatric surgery plus medical therapy may be a useful strategy for managing uncontrolled diabetes, according to the results of a recent study published in the New England Journal of Medicine.

Study compares infection risk for JIA, ADHD patients

Children with juvenile idiopathic arthritis were at twice the risk of infection compared with children with attention-deficit hyperactivity disorder, according to a study published May 1 in Arthritis & Rheumatism.

Improvements in warfarin therapy reduce stroke rate, study shows

Current use of warfarin as a stroke prevention therapy in patients with nonvalvular atrial fibrillation is associated with a lower rate of residual stroke or systemic embolism compared with previous data, according to a recent study published in the Archives of Internal Medicine.

FDA revises finasteride labels

"The labels of 2 formulations of finasteride, used to treat enlarged prostate and male-pattern baldness, are being revised to indicate that additional sexual side effects may persist after the drug has been discontinued, FDA announced"

Omega-3 shows no benefit for multiple sclerosis, study finds

The supplementation with omega-3 fatty acids has no benefit in treating multiple sclerosis, according to a clinical trial that appeared in the JAMA?s Archives of Neurology. However, researchers acknowledged the randomized controlled trial was underpowered.

11 recommendations reported for arthritis pain management

A set of 11 evidence-based recommendations for managing pain with pharmacotherapy in patients suffering inflammatory arthritis were reported by an international panel online March 24 in Rheumatology.

Study links phthalates to type 2 diabetes in elderly

"Phthalate metabolites, chemicals commonly used in plastics, cosmetics, and pharmaceuticals, were linked to an increased risk for the development of type 2 diabetes in the elderly, a recent study found. "

Doctors debate if all men with elevated cholesterol should take statins

"Doctors debate whether men with elevated cholesterol who are otherwise healthy should still take statins, in a new series in JAMA, Dueling Viewpoints. "

ISMP warns of severe side effects with infliximab therapy

The Institute for Safe Medication Practices (ISMP) is warning about the severe side effects associated with infliximab for rheumatoid arthritis, Crohn?s disease, and other autoimmune disorders.

Costs associated with neonatal abstinence syndrome climbs

US healthcare costs associated with neonatal abstinence syndrome (NAS) climbed from $39,400 in 2000 to $53,400 in 2009, and state Medicaid programs paid for the majority of the cases. Approximately 3.39 per 1,000 hospital births in 2009 had NAS compared with 1.20 in 2000, according to a report published online from JAMA.

Drug Watch: Multiple sclerosis

Drug Watch: Multiple sclerosis

Ivacaftor (Kalydeco): A treatment of cystic fibrosis for patients with G551D mutation in the CFTR gene

New molecular entity: FDA approved Ivacaftor, a treatment of cystic fibrosis for patients with a G551D mutation in the CFTR gene

CMS' Hospital Compare quality report site did not affect mortality, study indicates

New oral anticoagulants: Their impact on efficacy and safety in patients undergoing total hip and total knee replacement and their influence on postoperative management

With the aging of the US population, elective total hip and knee replacement operations have become more prevalent, and costs to the healthcare system for these procedures are increasing rapidly. This includes costs related to treatment of venous thromboembolism, which may be a consequence of these operations if appropriate postoperative thromboprophylaxis is not administered.

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Recent FDA action (through April 2012) related to, Dihydroergotamine, Levadex inhalation aerosol, droxidopa, Northera, Amitriptyline 4% ketamine 2% cream, AmiKet, Afilbercept, ZALTRAP, Nav rAAV8 vector, Carbamazepine, Carbatrol, Vancomycin hydrochloride, Vancocin, Irbesartan, irbesartan-hydrochloriderothiazide, Avapro, Avalide, Fluvastatin, Lescol

FDA updates drospirenone-containing birth control pill labels to emphasize possible increased risk of blood clots in women

Drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills, according to recent FDA observational (epidemiologic) studies.

Statins associated with decreased risk of depressive symptoms

Patients with coronary heart disease who used statins were at a decreased risk of depression; whether there is a cause-and effect relationship, however, merits further research, according to a study published online February 21 in The Journal of Clinical Psychiatry.

Apixaban: An orally active factor Xa inhibitor to prevent strokes and systemic embolism in patients with nonvalvular atrial fibrillation

Apixiban (Eliquis) is an orally active factor Xa inhibitor. Its manufacturers are seeking FDA approval to market apixaban to reduce risk of stroke and systemic embolism in patients with nonvalvular AF (NVAF).

Exenatide extended-release (Bydureon): A once-weekly treatment (along with diet and exercise) to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings

New formulation: FDA approved Exenatide extended-release, a once-weekly treatment (along with diet and exercise) to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings

FDA Actions in Brief April 2012

Recent FDA Approvals (through April 2012) related to (Johnson & Johnson, AstraZeneca, Affymax, Takeda Pharmaceutical, Teva Pharmaceutical Industries, Avioq, Hope Pharmaceuticals, Novo Nordisk, Avid Radiopharmaceuticals)

Clinical studies review findings on triple-antiplatelet therapy after PCI, investigational thrombin receptor antagonist

A report for the American College of Cardiology's Scientific Session & Expo

New system transmits CPE data, credits electronically

The National Association of Boards of Pharmacy, the Accreditation Council for Pharmacy Education (ACPE), and ACPE providers have teamed up to create the CPE Monitor. This new system will allow for the electronic transmission of continuing pharmacy education data.

FDA warns of pediatric accidental exposure to fentanyl patch

FDA has issued a safety alert, warning patients, caregivers, and healthcare professionals about the dangers of accidental exposure to and improper storage and disposal of fentanyl patches.

AAN issues new guidelines for migraine headaches

As many as 80% of patients who are candidates for preventive treatments for migraine headaches could be helped by these treatments, the author of new guidelines issued by the American Academy of Neurology told Formulary.

Lower rates of intracranial hemorrhage seen with Pradaxa

Twice-daily dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) was shown to be associated with lower rates of fatal and traumatic intracranial hemorrhage compared with warfarin, according to the results of a retrospective subanalysis published online, April 5, in Stroke, the Journal of the American Heart Association.

Innovation to control costs, access to care are top healthcare issues, survey says

More than 75% of the nation?s opinion leaders believe that the best way to control healthcare costs is through discovering innovative ways to deliver services, according to the new NEHI Innovation Barometer survey.

Novartis updates Gilenya label to include stronger cardiac warnings after FDA review

Novartis has agreed with FDA to update US prescribing information on fingolimod (Gilenya) to include updated patient selection parameters based on certain cardiovascular considerations to aid in the identification of candidates for Gilenya.

FDA's enhanced drug safety program is effective, CDER report says

FDA has strengthened its oversight of drugs after they've been approved, thanks to its updated postmarket drug safety program, according to a new report by the agency's Center for Drug Evaluation and Research.

FDA issues warning, contraindication for blood pressure medications containing aliskiren

FDA has issued a Drug Safety Communication (April 20) warning of possible risks when using blood pressure medicines containing aliskiren with angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations are contraindicated in patients with diabetes.

ADA, EASD issue joint position statement on hyperglycemia treatment for T2DM

Guidelines for managing elevated blood glucose levels in people with type 2 diabetes mellitus, developed jointly by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), are being published concurrently in the ADA?s journal, April 19 online edition of Diabetes Care and in EASD?s journal, Diabetologia.