Formulary Watch |

New study details increased international participation in US NHLBI-sponsored cardiovascular trials; further scrutiny warranted

National Heart, Lung, and Blood Institute-sponsored cardiovascular trials often enroll a "substantial" proportion of international participants.

Meta-analysis: anti-IL-12/23 agents or anti-tumor necrosis factor-alpha treatments have no effect on the cardiovascular risk of chronic plaque psoriasis patients

Biologic agents have no effect on the rate of major adverse cardiovascular events in patients suffering from chronic plaque psoriasis.

Collaborative helps pharmacists navigate EHR arena

The importance of ensuring that pharmacist-provided clinical services are represented in the electronic health record has come to the forefront with the Pharmacy e-Health Information Technology Collaborative.

Certain DMARDs associated with an increased incidence of diabetes in patients with psoriasis or RA

In patients with psoriasis or rheumatoid arthritis, the use of tumor necrosis factor inhibitors or hydroxychloroquine, but not methotrexate, was associated with a decrease in the incidence of diabetes compared to other disease-modifying antirheumatic drugs.

FDA Actions in Brief October 2011 (Remicade, Prolia, haloperidol injection, Soliris)

Recent FDA Approvals (through September 2011) related to Remicade, Prolia, haloperidol injection, Soliris

Osteoporosis: A review of current recommendations and emerging treatment options

Osteoporosis is a widespread condition with significant morbidity and mortality affecting millions of people in the United States and worldwide. Incidence is expected to increase as the population ages.

NSAIDs increase miscarriage risk in early pregnancy

Nonsteroidal anti-inflammatory drugs (NSAIDs) should be used with caution during pregnancy, as exposure may increase the risk of spontaneous abortion, reported a study published online September 6 in the Canadian Medical Association Journal.

Warfarin patients should be monitored for acetaminophen interactions

An interaction between warfarin and acetaminophen may result in significant elevations of international normalized ratio (INR), putting patients at increased risk for hemorrhagic complications.

M-EDTA demonstrates efficacy in prevention of CRB for hemodialysis patients

An antimicrobial lock solution containing minocycline in combination with EDTA (M-EDTA) reduces the rate of catheter-related bacteremia (CRB) in hemodialysis patients, according to the results of a study published online in the Journal of the American Society of Nephrology.

Lower-dose colchicine may benefit patients with first recurrence of pericarditis

Colchicine is a safe and effective treatment for patients who have had a first recurrence of pericarditis, according to a recent study published August 28, in the Annals of Internal Medicine.

FDA issues label change for TNF-alpha blockers to include risk of infection from Legionella and Listeria

FDA has notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from 2 bacterial pathogens, Legionella and Listeria.

FDA issues CRL to Janssen Biotech for golimumab sBLA

FDA has issued a complete response letter for a golimumab (Simponi, Janssen Biotech) supplemental Biologics License Application seeking an expanded label in the treatment of active psoriatic arthritis.

FDA panel recommends approval of rivaroxaban for stroke prevention

An FDA advisory panel voted 9-2 (with 1 abstention) to recommend approval for rivaroxaban (Xarelto, Johnson & Johnson and Bayer AG), an oral, once-daily anticoagulant as a treatment to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

FDA approves antipsychotic haloperidol injection, USP

FDA has approved an antipsychotic medication, haloperidol injection, USP (Sagent Pharmaceuticals), indicated for use in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette's disorder.

FDA Mini-Sentinel pilot launches

The first step toward a national electronic system that will transform FDA?s ability to track the safety of drugs, biologics, and medical devices is up and running, according to a recent press release announcing the Mini-Sentinel Pilot project.

Hospital admission may lead patients to unintentionally discontinue medications for chronic diseases

Patients discharged from the hospital are at an elevated risk of not continuing their long-term medications for chronic diseases, and ICU admission appears to further increase this risk, according a recent study published August 24 in the Journal of the American Medical Association.

FDA approves orphenadrine

FDA has approved orphenadrine citrate injection, USP (Sagent Pharmaceuticals) a skeletal muscle relaxant as an adjunct to rest, physical therapy, and other measures to support relief from acute, painful musculoskeletal conditions.

FDA reports serious allergic reactions with Saphris use

FDA has issued a Safety Announcement warning that serious allergic reactions have been reported with the use of the antipsychotic medication asenapine maleate (Saphris).

FDA acknowledges ongoing drug shortage, warns pharmacists of fraud

Drugs such as Taxol, Cytarabine, Daunorubicin, Doxil, and Leucovorin are in short supply, delaying patients with various forms of cancer from getting the treatments they need or forcing them to seek alternative, possibly less-effective treatments, FDA announced recently.

Repackaged Avastin causes eye infections in Florida

FDA is alerting healthcare professionals that repackaged intravitreal injections of Roche Holdings' Avastin (bevacizumab) have caused a cluster of serious eye infections in the Miami, Fla., area.

FDA approves Botox to treat a form of urinary incontinence

FDA has approved onabotulinumtoxinA (Botox, Allergan) for injection for the treatment of urinary incontinence resulting from detrusor overactivity associated with a neurologic condition (eg, spinal cord injury [SCI], multiple sclerosis [MS]) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

FDA approves icatibant to treat acute attacks of hereditary angioedema

FDA has approved icatibant (Firazyr, Shire Human Genetic Therapies) injection for the treatment of acute attacks of hereditary angioedema (HAE) in patients 18 years of age and older.

FDA Safety Alert: Abnormal heart rhythms associated with high doses of citalopram hydrobromide

FDA has notified healthcare professionals and patients that the antidepressant citalopram hydrobromide (Celexa, Forest Laboratories) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart.

FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer

FDA has notified healthcare professionals and patients that the antidepressant citalopram hydrobromide (Celexa, Forest Laboratories) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart.

Linaclotide reduces symptoms for patients with chronic constipation, studies show

Linaclotide, an investigational drug for the relief of chronic constipation, appears to be effective and safe, according to the results of two phase 3 trials published in the August issue of the New England Journal of Medicine.

Study provides first evidence-based colchicine dosing recommendations

Colchicine, a widely used drug for the prevention and treatment of gout flares, interacts dangerously with many commonly prescribed pharmaceuticals, such as antibiotics, anti-hypertensive drugs, anti-fungals, immunosuppresants and protease inhibitors, according to a study published in the August issue of Arthritis & Rheumatism. However, most patients can take colchicines safely with these medications as long as the dose is adjusted, the study indicated.

FDA approves tapentadol ER for management of moderate-to-severe chronic pain

FDA has approved tapentadol extended-release tablets (Nucynta ER, Janssen Pharmaceuticals), an oral analgesic taken twice daily, for the management of moderate-to-severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Formulary Digital Edition September 2011

Management of chronic obstructive pulmonary disease: An emphasis on recently approved medications and products in the pipeline; Focus On Boceprevir: A new oral protease inhibitor for the treatment of chronic hepatitis C

FDA approves crizotinib with companion diagnostic for a type of late-stage lung cancer

FDA has approved crizotinib (Xalkori, Pfizer), the first and only therapy specifically for patients with locally advanced or metastatic non-small-cell lung cancer that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

HRT reanalyses shows favorable risk-benefit profile with recommended treatment strategies

The risk-benefit ratio is in favor of hormone replacement therapy (HRT) when initiated near menopause, according to new consensus statements issued by The North American Menopause Society, The American Menopause Society and the International Menopause Society and published in a recent paper in the July issue of Women?s Health.