Clinical News

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.

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.

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.

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.

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.

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.

FDA has announced changes to the boxed warnings, contraindications, and warnings sections of the labels for 32 products.

On June 15, FDA published an online safety communication informing prescribers and patients that pioglitazone use may be associated with a 20% to 40% increased hazard of new bladder cancer.

Systemic lupus erythematosus is a serious, potentially fatal autoimmune disease that affects between 300,000 to 1.5 million Americans of all races. Restless legs syndrome is a disruptive neurologic disorder that affects up to 10% of all Americans.

Much ongoing research and discussion concerns the risks of using proton pump inhibitors with clopidogrel.

Big Pharma is going on an involuntary diet this year.

Bioinformatics researchers at Stanford University have uncovered a never-before-reported drug-drug interaction between pravastatin and paroxetine.

Continuing shortages of generic oncology chemotherapeutic agents dangerously limit patient-care choices, affect clinical outcomes, and stretch already tight pharmacy resources.

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.

American Regent Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP from the retail/hospital level.

FDA issued a warning last 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, according to the Safety Alert released August 3, the risk does not appear to be associated with the single low dose of fluconazole (150 mg) that is used to treat vaginal yeast infection (candidiasis).

More doctors who are not psychiatrists are prescribing antidepressants, making these drugs the third most commonly prescribed group of medications in the United States, according to a study published in the August issue of Health Affairs.