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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.

Backlog of ANDAs could be alleviated with passage of generic drug user fee act

Congressional approval of the bipartisan Generic Drug and Biosimilars User Fee Act could eliminate 90% of the backlog of Abbreviated New Drug Applications by 2017, FDA official Russell Wesdyk, BS, MBA, said in a presentation last month.

Generic Vancocin prompts industry speculation of FDA practices

FDA?s approval (April 10) of generic versions of ViroPharma?s antibiotic Vancocin (vancomycin hydrochloride) for the treatment of Clostridium difficile-associated diarrhea, has some industry experts wondering if FDA is trying to speed up the availability of generics or politically favor new company competition in select areas of therapy.

FDA approves pregnancy category change for insulin detemir injection

FDA has approved insulin detemir [rDNA origin] injection (Levemir, Novo Nordisk) pregnancy Category B classification, indicating that when used in pregnant women with diabetes, the injection did not increase the risk of harm to the unborn baby.

Study: Fibromyalgia patients taking pregabalin see improvement in sleep, daily pain

Fibromyalgia patients taking pregabalin had significant improvements in sleep and decreased daily pain, according to a new study published in the April 2012 issue of Arthritis Care & Research.

FDA approves first quadrivalent flu vaccine

FDA approved the first 4-strain influenza vaccine live, intranasal (FluMist Quadrivalent, MedImmune) for the prevention of influenza. The vaccine?s 4 strains (2 type-A and 2 type-B lineages) help provide broad protection against circulating influenza A and B.

Periprocedural dabigatran use is associated with higher major bleeding rate than warfarin, study finds

Patients using periprocedural dabigatran had a significantly higher major bleeding rate than those using warfarin, according to a study published online first February 1, 2012, in the Journal of the American College of Cardiology.

AMCP announces election results for 2012-2013 president-elect, directors

The Academy of Managed Care Pharmacy has announced election results for 2012-2013 president-elect and directors.

Retail pharmacists vow to keep fighting after Express Scripts-Medco merger approved

The Federal Trade Commission (FTC) approved the $29.1 billion merger of Express Scripts and Medco Health Solutions on Monday, but the retail pharmacy industry continues to fight the deal, vowing to push a request for a temporary restraining order (TRO) that it filed on Friday.

Drug Watch: Breast cancer

Breast cancer

3 studies find aspirin reduces risk of cancer deaths, metastasis

Aspirin can reduce the risk for cancer-related mortality and can reduce or prevent the risk for distant metastasis, according to 3 new studies published online by The Lancet and The Lancet Oncology.