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Formulary E-News
July 9, 2010
TOP SEARCHES: Pulmonary arterial hypertension // Lorcaserin // REMS requirements
In this issue
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Panitumumab trial
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HRT skin patches
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GI issues and NSAIDs
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Cardio risks and NSAIDs
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Exenatide
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Aspirin and diabetes
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Metformin use
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Migraine treatment
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ARBs
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Cancer care
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Epilepsy in children
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Tranexamic acid
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Celecoxib and GI events
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Tamoxifen
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Folic acid and vitamin B12
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Low back pain guidelines
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Endometriosis recommendations
Key Topic Updates

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A recent trial, published in the New England Journal of Medicine, concluded that the statin drug Crestor (rosuvastatin) lowered the combined risks of heart attack, stroke, other heart events or heart-related death by 47% in healthy patients with no history of heart problems or high cholesterol but high levels of C-reactive protein (CRP), a marker for inflammation.
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From the 101st annual meeting of the American Association for Cancer Research

Panitumumab trial uses gene technology to advance colorectal cancer therapy
Using massively parallel gene sequencing technology, researchers were able to identify specific genetic mutations that appear to be predictive of response to a drug commonly administered for metastatic colorectal cancer. The analysis involved banked patient tumor samples from a previous phase 3 trial and merits further investigation in larger studies, Marc Peeters, MD, PhD, said at the American Association for Cancer Research annual meeting in Washington. More...

Oral HRT carries higher risk than low-dose patches
Hormone replacement therapy (HRT) skin patches containing low doses of estrogen carry less risk of stroke than oral therapy and may represent a safer alternative, according to a study conducted by researchers at the Lady Davis Research Institute of the Jewish General Hospital, published June 4 in the British Medical Journal. More...
Risk of GI bleeding varies by NSAID type, dosage
The risk of gastrointestinal (GI) complications because of the use of nonsteroidal anti-inflammatory drugs (NSAIDs) varies by the specific drug and dosage, and those with a slow-release formulation or long half-life are associated with a greater risk, according to research published in the June issue of Arthritis & Rheumatism, as reported by HealthDay News. More...
Cardio risk for healthy people varies by specific NSAID
The use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) by healthy people is associated with an increased risk of cardiovascular death, but naproxen (Aleve, Bayer Consumer) appears to have a safer cardiovascular risk profile, according to a study published online June 8 in Circulation: Cardiovascular Quality and Outcomes, as reported by HealthDay News. More...
Year of weekly exenatide beneficial in type 2 diabetes
In patients with type 2 diabetes, a once-weekly formulation of exenatide (Byetta, Amylin Pharmaceuticals) is associated with sustained improvements in glycemic control and body weight over 52 weeks, and patients who switch from a twice-daily to a once-weekly regimen have further improvements in hemoglobin A1C and fasting plasma glucose, according to research published in the June issue of Diabetes Care, as reported in HealthDay News. More...
Less-costly aspirin found useful in newly diagnosed diabetes
The use of regular aspirin by individuals aged 40 and older who have been newly diagnosed with type 2 diabetes is a cost-effective treatment strategy, according to a study in the June issue of Diabetes Care, asreported by HealthDay News. More...
Metformin in diabetes linked to lower breast cancer risk
In women with type 2 diabetes, long-term metformin (Glucophage, Merck Serono) use is associated with a lower risk of breast cancer, according to research published in the June issue of Diabetes Care, as reported by HealthDay News. More...
New treatment launched for migraines in U.S.
A neurology-focused specialty pharmaceutical company has launched diclofenac potassium for oral solution (Cambia, Nautilus Neurosciences Inc.) for the acute treatment of migraine with or without aura in the United States. FDA approved the prescription medication in June 2009. More...
ARBs linked to modestly higher risk of cancer diagnosis
Angiotensin-receptor blockers (ARBs) appear to be associated with a modest increase in risk of a new cancer diagnosis, according to research published online June 14 in The Lancet Oncology, reported HealthDay News. More...
Costs thwart continued care for many cancer patients
Many cancer survivors delay or forgo medical care due to cost, and cancer survivors aged <65 are more likely to put off or forgo care than those without a history of cancer, according to research published online June 14 in Cancer, reported HealthDay News. More...
Prognosis favorable for most children with epilepsy
About 7 in 10 children who develop epilepsy experience terminal remission, while the condition becomes intractable in only about one in 10, according to a study published online June 14 in Epilepsia, reported HealthDay News. More...
Tranexamic acid reduces mortality in trauma patients
Tranexamic acid may be an effective option for reducing bleeding and mortality among trauma patients, without increasing the risk of serious complications such as myocardial infarction, stroke, or pulmonary embolism, according to a study published online June 15 in The Lancet, reported HealthDay News. More...
Celecoxib linked to lower rate of gastrointestinal events
The cyclooxygenase (COX)-2 selective nonsteroidal anti-inflammatory drug (NSAID) celecoxib is associated with a lower risk of gastrointestinal adverse events than the NSAID diclofenac plus the proton pump inhibitor (PPI) omeprazole in patients with osteoarthritis or rheumatoid arthritis, according to a study published online June 17 in The Lancet, reported HealthDay News. More...
Gene mutation increases clot risk in women on tamoxifen
Women taking adjuvant tamoxifen for early-stage breast cancer who develop a thromboembolism (TE) are nearly 5 times more likely to carry the factor V Leiden (FVL) mutation than women on the medication who don't have a TE, according to a study published online June 16 in the Journal of the National Cancer Institute, reported HealthDay News. More...
Folic acid, vitamin B12 do not reduce vascular events
Supplementation with folic acid and vitamin B12 over an extended period does not have a beneficial effect on vascular outcomes in individuals who have had a myocardial infarction, but it also poses no excess cancer risk, according to a study in the June 23/30 issue of the Journal of the American Medical Association, reported HealthDay News. More...
Recent low back pain guidelines offer similar advice
Recent clinical practice guidelines offer similar recommendations for assessing and managing low back pain, and clinicians can improve patient care by adopting these recommendations, according to a review published in the June issue of The Spine Journal, reported HealthDay News. More...
Updated recommendations for endometriosis released
Women who suffer from endometriosis-related pain should be treated first with conservative, non-surgical approaches and then with more invasive options if pain does not resolve, and hysterectomy only as a last resort, according to a practice bulletin issued by the American College of Obstetricians and Gynecologists (ACOG) and published in the July issue of Obstetrics & Gynecology, reported HealthDay News. More...
Key Topic Updates
FDA Approvals
Miconazole buccal tablets (Oravig): An –azole antifungal indicated for the local treatment of oropharyngeal candidiasis in adults
Estradiol valerate/dienogest (Natazia): The first 4-phasic oral contraceptive tablets for the prevention of pregnancy
FDA Actions in Brief June 2010 (Vimovo, CIP-Tramadol ER, Zymaxid, Lumizyme, Rapamune, Sprix)

In the Pipeline
FDA Pipeline Preview, June 2010 (BMS-224818, Roflumilast, Prostvac, Naltrexone, IL13-PE38QQR/IL13-PE, Prochymal, AEZS-108, SBC-102, Pralatrexate, RG283

Medication Safety
FDA to revise all PPI labels to warn about possible fracture risk
GnRH agonists' safety profile under FDA review for diabetes, CVD risks

Clinical News
ADA 2010: Findings add fuel to the rosiglitazone controversy
ADA 2010: Updated diagnosis, drug guidelines in gestational diabetes
ADA 2010: New diagnostic guidelines spur debate

Policy News
Extension of REMS requirements by FDA raises provider, manufacturer concer

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