Formulary Watch |

Late-breaking news: FDA approves new treatment for rare type of pancreatic cancer

FDA has approved everolimus (Afinitor, Novartis) tablets to treat patients with progressive neuroendocrine tumors of pancreatic origin that cannot be removed by surgery or that have spread to other parts of the body (metastatic).

AMCP names 4 new members to board

The Academy of Managed Care Pharmacy recently installed 4 new members to its board of directors. The new board members were sworn in April 29 at AMCP?s 23rd Annual Meeting & Showcase in Minneapolis.

Consider ER oxymorphone in patients with chronic low back pain, comorbidities

In patients with chronic low back pain with comorbidities such as hypertension, diabetes, and cardiovascular disease, extended-release oxymorphone (Opana ER, Endo Pharmaceuticals) may be a safe and effective alternative, according to a study presented at the annual meeting of the American Academy of Pain Medicine, National Harbor, Md.

Long-term combo naproxen/esomeprazole safe, effective

No new or unexpected safety issues occurred during long-term treatment with a fixed-dose combination of naproxen and esomeprazole magnesium (Vimovo) in patients at risk of NSAID-associated upper gastrointestinal ulcers, according to data presented at the annual meeting of the American Academy of Pain Medicine, National Harbor, Md.

FDA approves Zytiga for late-stage prostate cancer

FDA has approved abiraterone acetate (Zytiga, Centocor Ortho Biotech), an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

Low A1C level linked to higher risk of mortality in elderly

Hemoglobin A1c levels below 6% are associated with a small but significant increased risk of mortality in elderly patients, according to a retrospective cohort study published online in Diabetes Care.

FDA approves first meningococcal vaccine for infants and toddlers

FDA approved the use of meningococcal (A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra, Sanofi Pasteur) in children aged as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135.

Opioid-related mortality associated with daily dose for nonmalignant pain

A daily dose of opioids for nonmalignant pain is strongly associated with opioid-related mortality, and doses of 200 mg or more of morphine or equivalent are associated with a particularly high risk, according to a recent study published in the April issue of Archives of Internal Medicine.

FDA approves new treatment for type 2 diabetes

FDA approved linagliptin (Tradjenta, Boehringer Ingelheim and Eli Lilly) tablets, used with diet and exercise, to improve blood glucose control in adults with type 2 diabetes.

Formulary Digital Edition May 2011

A review of systemic lupus erythematosus and current treatment options; Focus on bazedoxefine; Agents in late-stage development for major depressive disorder and generalized anxiety disorder

Drug Watch: Major depressive disorder and generalized anxiety disorder (PDF) (May 2011)

Agents in late-stage development of major depressive disorder and generalized anxiety disorder.

PPI's efficacy and safety questioned for pediatric GERD

The effectiveness and safety of proton pump inhibitors for pediatric gastroesophageal reflux disease are far from proven, according to a new systematic review.

A review of systemic lupus erythematosus and current treatment options

Systemic lupus erythematosus is a multi-organ, autoimmune inflammatory disease. The annual incidence of SLE in the United States ranges from 2.0 to 7.6 cases per 100,000 persons per year. This review examines the clinical course of SLE, various treatment options, and the treatment of specific manifestations of the disease such as lupus nephritis.

FDA cautions prescribers of risk for severe immune-mediated adverse reactions with ipilimumab use

The FDA has released a safety communication alerting healthcare providers to a new risk evaluation and mitigation strategy for ipilimumab.

FDA Actions in Brief May 2011 (Actemra, Menactra, Zytiga, Rituxan, Invega, Vandetanib, Viramune XR, Horizant)

Recent FDA Approvals (through April 2011) related to Actemra, Menactra, Zytiga, Rituxan, Invega, Vandetanib, Viramune XR, Horizant

FDA, NIH, pharma companies seek new strategies to spur drug development

Drug devleopment pipelines have shrunk; fewer new products are being approved for market; and pharma companies are scaling back R&D as patent expirations on blockbuster drugs reduce industry revenues.

FDA Pipeline Preview, May 2011 (Eli Lilly, Vertex, Regeneron Pharmaceuticals, Nile Therapeutics, Provectus)

Recent FDA action (through April 2011) related to Liprotamase, Aricept Patch, Telaprevir, Restylane Injectable Gel, VEGF Trap-Eye, Cenderitide, PV-10, INNO-206

Bazedoxifene: An investigational selective estrogen receptor modulator for the treatment and prevention of osteoporosis in postmenopausal women

A new selective estrogen receptor modulator, bazedoxifene acetate, is currently under development in an effort to maximize potential benefits on bone, lipids and breast tissue while minimizing endometrial hyperplasia and other adverse effects.

New treatment guidelines strongly endorse use of biologic agents for many children with arthritis refractory to methotrexate

The American College of Rheumatology has developed new guidelines for starting and monitoring treatments for children with juvenile idiopathic arthritis.

Roflumilast oral treatment (Daliresp): Treatment to reduce COPD exacerbations in patients with severe COPD associated with chronic bronchitis

New molecular entity: Roflumilast oral treatment was approved by FDA as treatment to reduce risk of COPD exacerbations.

Genetic targets help alcohol addiction, study finds

Alcoholics who are tested for genotype specificity prior to receiving ondansetron may have significantly improved outcomes, according to new research.

Shorter treatment for hepatitis C virus may be possible with protease inhibitor

Analysis of the hepatitis C virus kinetics during treatment with protease inhibitor telaprevir shows a rapid decline, according to a new study.

First-time generic approval May 2011

Generic drug approved by FDA (through May 2011): Latanoprost

Azilsartan medoxomil tablets (Edarbi): Tablets for the treatment of hypertension alone or in combination with other antihypertensive agents

New molecular entity: Azilsartan medoxomil tablets are selective AT1 subtype angiotensin receptor antagonists that were approved by FDA to lower blood pressure.

Formulary Digital Edition May 2011

A review of systemic lupus erythematosus and current treatment options; Bazedoxifene: An investigational selective estrogen receptor modulator for the treatment and prevention of osteoporosis in postmenopausal women; Agents in late-stage development for the treatment of major depressive disorder and generalized anxiety disorder

Late-breaking news: FDA approves Zytiga for late-stage prostate cancer

FDA has approved abiraterone acetate (Zytiga, Centocor Ortho Biotech), an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

Twice-daily exenatide added to basal insulin improves glycemic control without excess hypoglycemia or weight gain

Adding twice-daily exenatide injections to (basal) insulin glargine improved glycemic control without increasing the risk for hypoglycemia or weight gain in patients with uncontrolled type 2 diabetes, according to a randomized and placebo-controlled trial.

FDA launches consumer-friendly recall website

This month, FDA launched its revamped Recalls, Market Withdrawals, and Safety Alerts website, making it easier for consumers to search and view food and product recall information going back to 2009.

New analysis shows fingolimod delays progression of MS disability

Fingolimod (Gilenya, Novartis) reduced the risk of disability progression in patients with relapsing-remitting multiple sclerosis, regardless of treatment history, according to a phase 3, 2-year study reported at the 63rd annual meeting of the American Academy of Neurology.

Dalteparin not better than unfractionated heparin for preventing DVT

Dalteparin was not better than unfractionated heparin for the prevention of deep vein thrombosis among critically ill patients, according to an international study published in the New England Journal of Medicine.