Formulary Watch |

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.

US healthcare system among least cost-effective in reducing mortality

The United States healthcare system is one of the least cost-effective in reducing mortality rates; while the United Kingdom is among the most cost-effective, according to a recent study published in the July issue of Journal of the Royal Society of Medicine Short Reports.

FDA-approved cyanide antidote launches

An antidote indicated for the treatment of acute cyanide poisoning judged to be life-threatening has launched.

Once-daily rivaroxaban appears to be as effective as dose-adjusted warfarin

Once-daily oral rivaroxaban (Xarelto, Bayer), a direct factor Xa inhibitor, appears to be as effective as dose-adjusted warfarin in preventing stroke or major embolism in patients with nonvalvular atrial fibrillation, according to a study published online August 10 in the New England Journal of Medicine.

Children's dose-dependent CA-MRSA risk increases with antibacterial use

Antibacterial drug use in children is associated with a dose-dependant increased risk of acquiring community-associated methicillin-resistant Staphylococcus aureus (Ca-MRSA), according to the results of a population-based, case-control study reported online August 1 in the Archives of Pediatrics & Adolescent Medicine.

FDA approves Adcetris to treat 2 types of lymphoma

FDA has approved brentuximab vedotin (Adcetris, Seattle Genetics) to treat 2 types of lymphoma.

FDA approves Zelboraf and companion diagnostic test for late-stage skin cancer

FDA has approved vemurafenib (Zelboraf, Genentech), the second melanoma drug this year to improve overall survival. Zelboraf is indicated for the treatment of patients with late-stage (metastatic) or unresectable melanoma, the most dangerous type of skin cancer.

FDA approves 2 new strengths of leuprolide acetate for treatment of children with central precocious puberty

FDA has approved 2 new strengths (11.25 mg and 30 mg) for 3-month administration of leuprolide acetate for depot suspension (Lupron Depot-PED, Abbott) for the treatment of children with central precocious puberty.

FDA approves single-tablet regimen for HIV-1 infection in treatment-naïve adults

FDA has approved emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Complera, Gilead Sciences), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults.

Results of biologics and specialty pharmacy research confirm knowledge gap

How much do employers know regarding biologics and specialty pharmacy?

FDA approves first antivenom for Centruroides scorpion stings

FDA has approved the first antivenom treatment specifically for a scorpion sting by the Centruroides scorpions in the United States. The new biologic treatment?called Anascorp?was designated an orphan drug and given priority review because adequate treatment did not exist in the United States, according to a consumer update and corresponding news release issued by the agency.

New guidelines for COPD diagnosis, management

The American College of Physicians (ACP), American College of Chest Physicians (ACCP), American Thoracic Society (ACT), and the European Respiratory Society (ERS) have issued updated recommendations to the 2007 ACP clinical practice guideline on diagnosis and management of stable chronic obstructive pulmonary disease (COPD). The new recommendations were published in Annals of Internal Medicine.

Statins may reduce risk of recurrent vascular events in young stroke patients

Young adults treated with a statin after a first ischemic stroke of undetermined cause were 77% less likely to suffer subsequent vascular events, according to a recent study published in Neurology.

FDA posts safety labeling changes for 32 products

Thirty-two products recently have had label changes to the boxed warnings, contraindications, and warnings sections, according to the FDA.

FDA warns unapproved emergency birth control may be ineffective, unsafe

FDA is warning consumers in the United States not to use an emergency birth control medicine labeled as Evital. According to a recent press release from the agency, Evital has not been approved by FDA, and the product may be a counterfeit version of the morning-after pill. It may not be safe or effective in preventing pregnancy.

Breaking news: CDC announces shortage of antimalarial drug primaquine

The Centers for Disease Control and Prevention warned this week that the antimalarial drug primaquine is not available until September, 2011.

Foundation for Managed Care Pharmacy appoints 4 new trustees

The Board of Trustees of the Foundation for Managed Care Pharmacy (FMCP), the educational and philanthropic arm of the Academy of Managed Care Pharmacy (AMCP), has announced the appointment of 4 new FMCP Trustees.

FDA, international counterparts report progress on drug inspection collaboration

The results of pilot programs focused on increasing international regulatory collaboration among the agencies that aim to enhance drug quality and safety globally, have been released by FDA together with its European and Australian counterparts.

American Regent recalls Vasopressin Injection, USP

American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the retail/hospital level. The company initiated the product recall because some vials may not maintain potency throughout their shelf-life.

FDA warns fluconazole in early pregnancy may cause birth defects

FDA issued a warning this week that chronic high doses (400 mg/day to 800 mg/day) of fluconazole (Diflucan) during the first trimester of pregnancy may be associated with specific birth defects in infants. However, the risk does not appear to be associated with a single, low dose of fluconazole (150 mg), which is used to treat vaginal yeast infection (candidiasis), according to the Safety Alert released August 3.