Formulary Watch |

5-alpha reductase inhibitors reduce prostate cancer risk, but not all experts are ready to support their chemopreventive role

Chemoprevention with dutasteride (a 5-alpha reductase inhibitor or 5-ARI), given at a dose of 0.5 mg daily, reduced the risk of incident prostate cancer detected on biopsy and improved outcomes related to benign prostatic hyperplasia, according to the results published in the April 1, 2010, edition of the New England Journal of Medicine.

Health reform expands drug coverage, supports outcomes research

The massive health reform legislation approved by Congress in March promises to significantly expand the number of Americans with healthcare coverage and pharmacy benefits.

"At-risk" generic launches can be unpredictable

"At-risk" generic launches refer to generic pharmaceuticals that are approved by FDA based on the review of an abbreviated new drug application (ANDA) and are subsequently launched while patent litigation is ongoing.

Rifaximin (Xifaxan): A gut-selective antibiotic approved for the reduction in risk of overt hepatic encephalopathy recurrence in patients ≥18 years of age

New indication: Rifaximin (Xifaxan) was approved in March 2010 for the reduction in risk of overt hepatic encephalopathy recurrence in patients ≥18 years of age.

FDA approves a more tamper-resistant formulation of OxyContin

FDA granted marketing approval for a new formulation of controlled-release oxycodone (OxyContin, Purdue Pharma) on April 5, 2010.

Doxepin (Silenor): A histamine H1-receptor antagonist for the treatment of insomnia

New Formulation: Doxepin (Silenor) was approved in March 2010 for the treatment of insomnia.

Meta-analysis finds antidiabetic drugs lower glucose similarly when added to metformin in type 2 diabetes mellitus

According to a systematic review in the April 13, 2010 edition of the Journal of the American Medical Association, noninsulin antidiabetic drugs show similar reductions in glycosylated HbA1c when used in combination with metformin in type 2 diabetics, but differ in their rates of hypoglycemia and weight gain.

Ticagrelor: An oral, non-thienopyridine P2Y12 receptor antagonist for the treatment of acute coronary syndromes

Clinical studies of patients with both ST-elevation and non-ST-elevation acute coronary syndromes have shown that ticagrelor, when compared with clopidogrel, reduces the rates of vascular death and myocardial infarction while increasing the rate of non-coronary artery bypass graft-related major bleeding. Ticagrelor was also associated with a higher incidence of dyspnea and ventricular pauses.

First-time generic approvals May 2010

Generic drugs approved by FDA (through April 2010): Losartan potassium tablets in 25-mg, 50-mg, and 100-mg, Losartan potassium and hydrochlorothiazide tablets in 50 mg/12.5 mg, 100 mg/12.5-mg, and 100 mg/25 mg, Hydromorphone hydrochloride injection, Mesna injection

FDA Actions in Brief May 2010 (Zortress, OxyContin, Exalgo, Kaletra, Provenge, Dacogen, Asclera, Pancreaze, Tarceva, Oravig)

Recent FDA approvals (through April 2010) related to Zortress, OxyContin, Exalgo, Kaletra, Provenge, Dacogen, Asclera, Pancreaze, Tarceva, Oravig

Formulary Digital Edition May 2010

Guideline-specific management of atrial fibrillation; Focus on ticagrelor; Agents in late-stage development for the treatment of epilepsy and seizure disorders

ACEI and ARB use in pregnancy an increasing concern

Despite being known teratogenic agents contraindicated in pregnancy, angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin-receptor blockers (ARBs) are being increasingly prescribed to women with hypertension during their childbearing years.

Liraglutide may improve glycemic control in patients with type 2 diabetes

A clinical study showed patients who switched from exenatide twice daily to liraglutide once daily experienced further reductions in hemoglobin A1c and weight loss when added to oral antidiabetes drugs (OADs).

Healthcare professionals should consider antidepressants for patients with physical illnesses

Antidepressants can help depressed patients with physical illness, and healthcare professionals should consider them more often, new research underscores.

Ticagrelor use leads to lower mortality after coronary artery bypass graft surgery

Patients with acute coronary syndrome (ACS) who undergo coronary artery bypass graft (CABG) surgery are less likely to develop fatal outcomes when given ticagrelor instead of clopidogrel as an antiplatelet medication, new research indicates.

Genetic testing may provide more accurate warfarin dose, lower risk of bleeding and clots

Physicians who check the DNA of patients before initiating warfarin therapy are more likely to provide the correct dose, avoiding the possibility of readmittance to a hospital.

Formulary Digital Edition April 2010

Reducing cardiovascular risk is patients with type 2 diabetes: management of dyslipidemia; Focus on naproxicond; Drug Watch: Agents in late-stage development for the treatment of hepatitis C

New black box warning for clopidogrel: "Poor metabolizers" of the drug may remain at risk for heart attack, stroke, and cardiovascular death

On March 12, 2010, FDA announced that the manufacturers of clopidogrel, an antiplatelet agent given to reduce the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease, will be placing a new black box warning into the drug's prescribing information.

Velaglucerase alpha for injection (VPRIV): An enzyme replacement therapy approved as a long-term treatment for type 1 Gaucher disease

New molecular entity: Velaglucerase alpha for injection (VPRIV) was approved February 2010 as an enzyme replacement therapy for the long-term treatment of type 1 Gaucher disease in pediatric and adult patients.

SSRI escitalopram improves cognitive function recovery in recent stroke survivors

A randomized controlled trial of recent stroke survivors found that patients receiving the selective serotonin reuptake inhibitor escitalopram had greater improvement in global cognitive function than those receiving placebo or Problem Solving Therapy.

First-time generic approvals April 2010

Generic drugs approved by FDA (through February 2010): Tamsulosin hydrochloride capsules, 0.4 mg, Imiquimod cream, 5%, Diltiazem hydrochloride extended-release tablets

Reducing cardiovascular risk in patients with type 2 diabetes: management of dyslipidemia

Cardiovascular disease (CVD) remains the leading cause of death in patients with diabetes mellitus, accounting for 50% of all deaths. Dyslipidemia is an important modifiable risk factor in diabetic patients and represents a key area for intervention in these patients. Diabetic patients have a lipid profile characterized by low high-density lipoprotein cholesterol (HDL-C) levels and an increase in triglyceride levels. Diabetics have increased numbers of low-density lipoprotein cholesterol (LDL-C) particles but with a shift to smaller, denser LDL-C particles. The net effect is that patients with type 2 diabetes do not have substantially higher LDL-C concentrations than patients without diabetes.

Dalfampridine (Ampyra): A potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis

New molecular entity: Dalfampridine (Ampyra) was approved in January 2010, as a treatment to improve walking in patients with multiple sclerosis.

Naproxcinod: A first-in-class cyclooxygenase-inhibiting nitric oxide donor for osteoarthritis pain

Naproxcinod, a cyclooxygenase-inhibiting nitric oxide donor, is pending FDA approval for the indications of knee and hip osteoarthritis. Treating osteoarthritis pain can be challenging because many agents commonly used for this indication carry potential risk for increased cardiovascular events including increased blood pressure, increased upper gastrointestinal bleeding, and increased hepatotoxicity.

FDA information systems, Sentinel Initiative seek more timely drug safety information

New added financial incentives are slated to drive adoption of electronic health record systems by doctors and hospitals, and increased government funding may finally lead to standards for interoperability and e-health exchanges necessary for the free flow of secure health data.

FDA actions in brief, April 2010 (Silenor, Carbaglu, Hizentra, Norditropin FlexPro, Xifaxan, Differin, Botox)

Recent FDA approvals (through April 2010) related to Silenor, Carbaglu, Hizentra, Norditropin FlexPro, Xifaxan, Differin, Botox

Drug Watch: Agents in late-stage development for the treatment of hepatitis C (PDF) (April 2010)

Agents in late-stage development for the treatment of hepatitis C.

Study drug improves survival for advanced prostate cancer

Results from a Phase 3 trial by Sanofi-aventis have shown that the investigational compound, cabazitaxel, and prednisone/prednisolone markedly enhanced overall and progression-free survival in patients with metastatic hormone-refractory prostate cancer where the disease advanced after treatment with docetaxel-based chemotherapy.

Combination treatment may work in severe acne cases

Adding Epiduo (adapalene and benzoyl peroxide) gel 0.1%/2.5% to doxycycline, 100 mg, may be an effective treatment for severe acne, according to results from a study sponsored by Galderma Laboratories.

Cancer drug approvals evaluated by government

More than 50 new indications for oncology and hematology drugs and biologics were cleared by the FDA?s Office of Oncology Drug Products from 2005 to 2007.