Formulary Watch |

Lamotrigine may be most effective antiepileptic drug

Of 10 antiepileptic drugs (AEDs) studied in older adults with epilepsy, lamotrigine closely followed by levetiracetam is the most effective, as measured by 12-month retention and freedom from seizures, while oxcarbazepine is consistently less effective than other AEDs, according to research published in the April issue of the Archives of Neurology, as reported by HealthDay News.

Cotrimoxazole tied to bleeding in older patients on warfarin

In older patients treated with warfarin, the use of cotrimoxazole is associated with a higher risk of upper gastrointestinal tract hemorrhage than other common antibiotics, according to research published in the April 12 issue of the Archives of Internal Medicine, as reported by HealthDay News.

Liraglutide found superior to sitagliptin for reduction of HbA1c in type 2 diabetics

Liraglutide offered superior glycemic control to sitagliptin in patients with type 2 diabetes who had inadequate glycemic control on metformin, according to a recent report in The Lancet.

Your response to healthcare reform

Since Congress passed healthcare reform legislation in March, Formulary has continued to ask for your feedback. Here is your response.

Guideline-specific management of atrial fibrillation

Each pharmacologic management strategy for atrial fibrillation has limitations and more research is needed to determine which agents are equally effective, yet safer alternatives. Providing thromboprophylaxis to decrease risk of ischemic stroke is a well-validated approach. However, deciding between rhythm or rate control may not be as straightforward.

FDA panel recommends continued use of Rotarix and RotaTeq vaccines despite viral DNA contamination

Despite known contamination with porcine circovirus type 1, an FDA advisory panel recently agreed that Rotarix (GlaxoSmithKline) and RotaTeq (Merck), two approved vaccines to prevent rotavirus infection, should continue to be used.

Drug Watch: Agents in late-stage development for the treatment of epilepsy/seizure disorders (PDF) (May 2010)

Agents in late-stage development for the treatment of epilepsy/seizure disorders.

Stakeholder collaboration can aid REMS implementation

FDA Amendments Act of 2007 included provisions for sponsors to submit Risk Evaluation and Mitigation Strategies for select pharmaceuticals, if FDA considered it necessary to ensure that its benefits outweigh its risks.

FDA not ready to declare link between oral bisphosphonates and atypical subtrochanteric femur fractures

On March 10, 2010, FDA announced that its review of data requested in June 2008 from all bisphosphonate drug manufacturers did not suggest an increased risk of subtrochanteric femur fractures (bone breaks just below the hip) in those receiving oral bisphosphonates.

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