Formulary Watch |

Oral naproxen, sumatriptan provides comparable post-emergency department recurrent headache relief

For patients experiencing headache recurrence within 48 hours of an emergency department discharge, naproxen 500 mg or sumatriptan 100 mg taken orally relieves recurrent primary headache (including migraine, tension type, and cluster headaches) pain comparably, according to a report published in a recent issue of Annals of Emergency Medicine.

FDA orders halt to production and marketing of unapproved single-ingredient oral colchicine

FDA has requested that all companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever, stop the manufacturing of this drug.

DMARDs, glucocorticoids, biologics similar for treatment of RA

Treatment of rheumatoid arthritis (RA) with disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, biologics, or a combination of these agents significantly reduces radiographic evidence of joint destruction, with no advantage seen for patients whose treatment includes biologics, according to research published in the October issue of Arthritis & Rheumatism.

No benefit to early chemo in ovarian cancer relapse

For women whose ovarian cancer has been in remission, restarting chemotherapy early on the basis of heightened CA125 concentration does not improve survival compared with postponing treatment until symptoms of relapse appear, according to a study published in the Oct. 2, cancer-themed issue of The Lancet.

Giving more people statins could cost effectively prevent heart attacks

Giving cholesterol-lowering statin drugs to more people could be a cost-effective way of preventing heart attacks, US researchers said Sept. 27, as reported by Reuters. The study was published in Circulation.

FDA grants ipilimumab priority review

Ipilimumab (Bristol-Myers Squibb) intended to treat patients with stage III or IV metastatic melanoma has been granted priority review by FDA.

Prophylactic antivirals reduce corneal disease recurrences

Individuals with ocular herpes simplex virus treated with prophylactic oral antibiotics appear to be at a lower risk of recurrence of epithelial keratitis, stromal keratitis, conjunctivitis, and blepharitis, according to research published in the September issue of the Archives of Ophthalmology, as reported by HealthDay News.

Supplements glucosamine and chondroitin don't help in treatment of arthritis

Two popular supplements used to treat joint pain don't work and health authorities should stop paying for them, according to a new study, as reported by HealthDay News

Simplified heart-risk guideline may miscalculate chance for coronary event

A method that is widely used to predict the risk of a major coronary event may over- or underestimate the risk for millions of Americans, according to a study directed by a researcher at the San Francisco VA Medical Center (SFVAMC) and the University of California, San Francisco (UCSF).

Use of medications for insomnia or anxiety may increase mortality risk

Taking medications to treat insomnia and anxiety increases mortality risk by 36%, according to a study by the School of Psychology at the University of Laval (Canada). Details of the study were published in the September issue of the Canadian Journal of Psychiatry.

GBCAs to include warning on NSF risk

FDA is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of nephrogenic systemic fibrosis (NSF), a rare and potentially fatal condition, if the drug is administered to certain patients with kidney disease.

Panel says bisphosphonate use may lead to atypical thigh-bone fractures

While bisphosphonate drugs are highly effective in reducing common bone fractures in individuals with osteoporosis, a task force announced that the drugs, when used long term, may be associated with atypical but serious fractures of the thigh bone.

FDA approves first oral MS treatment

FDA has approved fingolimod (Gilenya, Novartis), 0.5 mg daily, as a first-line treatment to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS). It is the first oral MS treatment approved in the United States.

Formulary Digital Edition, September/October 2010

Opioid abuse and dependence: Treatment review and future options; Focus on dronedarone for atrial fibrillation; Agents in late-stage development for pulmonary diseases.

Risk management, drug safety raise challenges for sponsors and healthcare providers

Intense public scrutiny of drug safety issues is prompting FDA to take a closer look at its program for establishing Risk Evaluation and Mitigation Strategies. Healthcare providers, as well as pharmaceutical companies, believe that the program is being overused, raising costs, and interfering with patient treatment.

Drug Watch: Pulmonary disease agents (PDF) (September/October 2010)

Agents in late-stage development for pulmonary disease.

Some antiretroviral drugs used to treat HIV associated with an elevated risk of myocardial infarction

A new case-control study nested within a large database of human immunodeficiency virus (HIV)-infected patients found abacavir initiation was associated with increased odds of having a myocardial infarction, while longer exposure to abacavir was not.

CYP1A2-inducing medications improve platelet responsiveness to clopidogrel

Platelet response to clopidogrel (Plavix) may be enhanced by concomitant use of agents that induce cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2), according to research presented during the 39th annual meeting of the American College of Clinical Pharmacology, Baltimore.

New biologic: Alpha-1-proteinase inhibitor (human) for injection (Glassia): A new chronic augmentation and maintenance therapy for emphysema due to alpha-1-antitrypsin deficiency

New biologic: Alpha-1-proteinase inhibitor (human) for injection (Glassia) was approved for the treatment of chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor.

Dronedarone for atrial fibrillation: An update of clinical evidence

Atrial fibrillation (AF) is the most common form of arrhythmia, affecting an estimated 2.2 million people in the United States. The goal of treatment is to reduce symptoms through rate or rhythm control and to prevent a cardioembolic event. Dronedarone (pronounced droe'' ne' da rone) is a noniodinated benzofuran derivative with characteristics of all 4 Vaughan-Williams antiarrhythmic classes. A search in clinicaltrials.gov for dronedarone phase 3 studies yielded 5 randomized controlled studies that investigated the efficacy and safety of the drug.

FDA Actions in Brief September/October 2010 (Gilenya, Prolia, Krystexxa, Faslodex, Protopam Chloride, Ozurdex, Suboxone Film, Saphris, Tekamlo, Beyaz)

Recent FDA Approvals (through August/September 2010) related to Gilenya, Prolia, Krystexxa, Faslodex, Protopam Chloride, Ozurdex, Suboxone Film, Saphris, Tekamlo, Beyaz.

Patients with RA refractory to anti-TNF-α may respond to tocilizumab

Tocilizumab (Actemra), an interleukin-6 receptor inhibitor, may be effective in the treatment of patients with rheumatoid arthritis who have an inadequate response to anti-tumor necrosis factor-α therapy, according to research presented here at the 39th annual meeting of the American College of Clinical Pharmacology, Baltimore.

Robust NHL drug pipeline calls for comparative trials

Non-Hodgkin's lymphoma (NHL) has several subtypes, with subtle variations, which leads to reduced effectiveness of standardized therapies. The introduction of rituximab, which targets B-cells, has had a positive effect on the management of NHL, but much still needs to be accomplished.

Opioid abuse and dependence: Treatment review and future options

Pain is a significant medical problem and choosing the appropriate treatment may be complex. Opioids are considered a gold standard in the treatment of pain and as pain management has become a more prominent strategy, opioid dependence has become more frequent. The misuse and abuse of opioids have also increased. Successful management of opioid dependence requires utilization of both pharmacologic and nonpharmacologic treatment.

Dutasteride and tamsulosin (Jalyn): A combination of dutasteride, a 5α-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist for the treatment of symptomatic benign prostatic hyperplasia

New combination: Dutasteride and tamsulosin (Jalyn) was approved by FDA for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

MoxDuo IR study completion could yield primary pain relief end points

QRxPharma has announced a successful interim analysis of its final MoxDuo IR pivotal phase 3 study required for new drug application (NDA) submission.

Findings of meta-analysis suggest concurrent metformin administration may reduce the metabolic risk of those taking atypical antipsychotic agents

A systematic review and meta-analysis conducted by researchers at the University of Connecticut (UCONN) School of Pharmacy, Storrs, Conn., and Hartford Hospital, Hartford, Conn., suggest that using metformin along with atypical antipsychotic agents (such as olanzapine, risperidone, quetiapine, and clozapine) may result in better anthropometric measurements and decreased insulin resistance.

New black-boxed warning added to leflunomide prescribing information: warns of severe liver injury

In mid July, FDA released a drug safety communication to rheumatologists and family physicians warning them that the use of leflunomide (Arava, Sanofi-Aventis)-a drug to treat rheumatoid arthritis-has been linked to an increased risk of severe liver injury.

FDA proposes withdrawal of marketing approval for midodrine hydrochloride

In mid August, FDA issued a ?Proposal to Withdraw Marketing Approval and Notice of Opportunity for a Hearing? to the companies that manufacture midodrine hydrochloride (ProAmatine, Shire Development Inc., and generics by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories).

FDA warns lamotrigine likely associated with aseptic meningitis

On August 12, 2010, FDA released a safety communication to prescribers and patients warning that lamotrigine (Lamictal, Lamictal ODT, Lamictal CD, Lamictal XR), a medication commonly used for seizures in children ≥2 years of age and bipolar disorder in adults, can cause an inflammation of the meninges (the protective membranes that cover the brain and spinal cord) called aseptic meningitis.