News

Severe liver injury, including 2 cases of acute liver failure leading to liver transplant in patients treated with the medication, has been associated with the use of dronedarone (Multaq), according to an FDA Drug Safety Communication announcement.

FDA has approved a label update to include a 200-mg formulation of etravirine (Intelence, Tibotec Therapeutics), a non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 in adults resistant to an NNRTI and other antiretroviral agents.

Twenty-four-day oral contraceptive regimens containing a progestogen with a long half-life shows higher contraceptive effectiveness under routine medical conditions compared with conventional 21-day regimens, according to research published in the January 2011 issue of Obstetrics & Gynecology.

FDA has approved fentanyl (Abstral, ProStraken) transmucosal tablets to manage breakthrough pain for adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gum, tongue), or the nasal passages or throat where they dissolve and are absorbed.

The Infectious Diseases Society of America is set to release its first guidelines for the treatment of the increasingly common and potentially deadly methicillin-resistant Staphylococcus aureus infection.

The impact of generic drugs-which now account for more than 70% of all prescriptions dispensed in the United States-will continue to increase as some of the world's most-prescribed products lose their patent protection in 2011 and begin facing generic competition.

FDA is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule.

FDA has approved fentanyl (Abstral, ProStraken) transmucosal tablets to manage breakthrough pain for adults with cancer.

In a guest editorial, 2 researchers highlighted the importance of the FDA approval in October of dabigatran etexilate (Pradaxa, Boehringer Ingelheim), an oral thrombin inhibitor that provides an alternative to warfarin (Coumadin, Bristol-Myers Squibb) for long-term stroke prevention in patients with non-valvular atrial fibrillation.

Patients who are newly treated with statin-fibrate concurrent therapy are slightly more likely to be hospitalized with rhabdomyolysis than those who take just one of the medications, according to research published in the American Journal of Cardiology, HealthDay News reported.

Many serious or potentially fatal adverse reactions associated with new, targeted anticancer agents are not reported in the original published research on the drug, and they are not known to oncologists until years later when updated drug labels, including boxed warnings, are required, according to research published online in the Journal of Clinical Oncology, HealthDay News reported.

Daily aspirin taken for at least 5 years appears to greatly reduce mortality from gastrointestinal and non-gastrointestinal cancers, according to research published online in The Lancet, HealthDay News reported.

Agents in late-stage development for the treatment of osteoporosis and related bone disease.

A combination of lapatinib, trastuzumab, and paclitaxel significantly improved tumor response rates in patients with human epidermal growth factor receptor 2-positive breast cancers, according to a new study presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, San Antonio, Texas.

Recent FDA action (through, December 2010) related to Ezogabine, Ticagrelor, Naltrexone SR/bupropion, Clostridium difficile vaccine, Elacytarabine, Glycerol phenylbutyrate, Perifosine, Cladribine Tablets, Florbetapir, ALS-AVP-21D9, Cyclosporine, PRX-8066, QLT091001.

New indication: Denosumab (Xgeva) has been approved for prevention of skeletal-related events from bone metastases from solid tumors.

Patients with rheumatoid arthritis who are seen by a rheumatologist within 12 weeks of symptom onset were likely to experience less joint destruction and have a higher chance of achieving disease modifying anti-rheumatic drug-free remission, according to a new study published December 2010 in Arthritis & Rheumatism.

Parkinson's disease, which decreases the amount of dopamine in the brain, affects about 1 million Americans. Available medical therapy cannot modify the progression of the disease; medications have only been shown to alleviate its symptoms.

Generic drugs approved by FDA (through December 2010): Levocetirizine tablets

New combination: Saxagliptin and metformin extended release (Kombiglyze XR) was approved to improve glycemic control in adults with type 2 diabetes mellitus.

Antihypertensive therapy with an angiotensin receptor blocker is not associated with reductions in cardiovascular or all-cause mortality compared to non-ARB-based regimens in patients with type 2 diabetes, according to researchers at the Massachusetts College of Pharmacy and Health Sciences.

Recent FDA Approvals (through December 2010) related to Amturnide, Prezista, Safyral, Gardasil, Atelvia

As compared to fluorouracil, doxorubicin, and cyclophosphamide, an adjuvant taxane-based regimen containing docetaxel, doxorubicin, and cyclophosphamide was shown to increase the rate of disease-free survival by 32% among women with high-risk, node-negative breast cancer.

FDA is requiring a new warning be added to the prescribing information for saquinavir (Invirase) detailing the drug's potential to prolong both QT and PR intervals on an electrocardiogram, and thus potentially cause the dangerous abnormal heart rhythms called torsades de pointes and complete heart block.

Technosphere insulin is an inhaled form of regular human insulin with a rapid onset of action (~15 min) that is being considered for approval for the treatment of type 1 and type 2 diabetes mellitus. Technosphere insulin has shown efficacy in decreasing the level of glycosylated hemoglobin in a dose-dependent manner.

Top-selling pediatric OTC analgesic, cough and cold, allergy, and gastrointestinal liquid medications in the United States are plagued with highly variable and inconsistent dosing directions and measuring devices, according to a study published ahead-of-print on the Journal of the American Medical Association's website.

Researchers from the Cincinnati Children's Hospital Medical Center have demonstrated that the tumor necrosis factor-alpha inhibitor etanercept is associated with significant increases in height, weight, and body mass index in children with juvenile idiopathic arthritis, according to a study recently published in Arthritis & Rheumatism.

Oncology treatment and benefits are changing. Buy-and-bill, the traditional methodology that had physicians buy chemotherapeutic products, treat in the office, and bill the payer, is going the way of surgery by barbers. But no one is quite sure what will replace the one-time standard of payment.