Health System

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 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.

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.

Pharmacy practice may be changing on many levels, but this pharmacist's vivid word-pictures remind us that some basic issues have never gone away.

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.

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

When added to usual treatment, azithromycin taken daily for 1 year decreased the frequency of chronic obstructive pulmonary disease (COPD) exacerbations and improved quality of life among patients, reported a study published August 25 in the New England Journal of Medicine.

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 ALK-positive as detected by an FDA-approved test.

An innovative pharmacy coaching program from Anthem Blue Cross and Blue Shield in Ohio has helped a number of patients better manage diabetes and hypertension.

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.

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

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 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.

Last summer FDA announced an action plan for medical countermeasures, such as drugs, vaccines, and diagnostic tests, to be used in responding to a public health emergency. The part of that effort aimed at regulatory science for medical countermeasures has been getting off the ground in recent months, FDA said in an August 19 presentation, with 85 intramural research projects in different parts of the agency.

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

A pharmacist-directed anticoagulation service greatly improved care for warfarin patients, reported a new study published in the July/August issue of the Journal of Hospital Medicine.

Medicare Part D beneficiaries who are responsible for 100% of previously subsidized prescription costs are twice as likely to discontinue their medications, according to a new study published in PLoS Medicine.

Pharmacy and dental organizations are uniting to promote oral health and raise public awareness of dry mouth, a side effect commonly caused by taking prescription and over-the-counter medications.

Antibacterial drug use in children is associated with a dose-dependent 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.

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.

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

Apricus Biosciences and its wholly owned subsidiary, NexMed USA, have received FDA approval for over-the-counter sales of antifungal drug Tolnaftate-D, containing the company's NexACT technology, which transiently loosens the tight junction between the cells of the sealed skin to allow more permeation.

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

Medication storage was one of the biggest problems that The Joint Commission found in hospitals in 2010, according to its new survey. During a webinar this week, sponsored by the Institute for Safe Medication Practices, Darryl Rich, PharmD, surveyor in the Joint Commission's Division of Accreditation and Certification Operations, also described some new requirements in the Commission?s National Patient Safety Goals for 2011.

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 has approved vemurafenib (Zelboraf, Daiichi Sankyo and 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.

Soon after a report revealed an average 650% markup on "gray-market" drugs, which are used when there is a shortage of other drugs, U.S. senators called for an FDA hearing on drug shortages.

FDA has assigned a Prescription Drug User Fee Act action date of March 27, 2012, for the review of the New Drug Application for the investigational agent peginesatide (formerly known as Hematide). If approved, peginesatide will be the first once-monthly erythropoiesis stimulating agent available for the treatment of anemia associated with chronic kidney disease in patients on dialysis in the United States.

The Institute for Safe Medication Practices is warning pharmacists, physicians, and nurses against misadministration of insulin through inappropriate dosing and treatment of hyperkalemia.

Pharmacy benefit managers should be required to be more transparent in health insurance exchanges, the National Community Pharmacists Association asserted in comments recently submitted to the U.S. Office of Personnel Management (OPM).