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Weekly News Round Up - March 28, 2012

Drug Safety Update: Celexa Maximum Dose, Risk of Abnormal Heart Rhythm

FDA updates dose and warning recommendations for Celexa; warns of increased risk of altered heart rhythms Read More...

Celexa (citalopram) is not recommended to be used in doses over 40 mg per day in any patient due to an increased risk of altered electrical activity of the heart (QT prolongation), which may lead to dangerous abnormal heart rhythms (Torsades de Pointes). Although use of citalopram is not recommended in patients with certain conditions due to the risk of QT prolongation, the FDA is updating the citalopram label to describe new precautions if use is required in these patients. The revised label also states the maximum citalopram dose is 20 mg per day for patients who are older than 60 years of age, have hepatic impairment, are CYP (cytochrome P450) 2C19 poor metabolizers, or take drugs that inhibit CYP2C19. In these patients, 20 mg per day should not be exceeded due to the risk for elevated citalopram blood levels that may lead to QT prolongation and Torsades de Pointes. Citalopram is in the selective serotonin reuptake inhibitor (SSRI) class, which also includes medications such as Prozac, Lexapro and Zoloft.

Omontys Approved For Dialysis Patients with Anemia Due to Chronic Kidney Disease

Omontys injection approved for the treatment of anemia due to chronic kidney disease in patients on dialysis Read More...

The U.S. Food and Drug Administration (FDA) has approved Omontys (peginesatide), a once-a-month erythropoiesis-stimulating agent (ESA) for anemia of chronic kidney disease (CKD) in patients receiving dialysis. Omontys should not be used in patients with CKD who are not receiving dialysis or who have cancer-related anemia, due to the risk for cardiovascular adverse events. Omontys stimulates red blood cell production in the bone marrow, increases hemoglobin (Hb) counts, and lowers the need for blood transfusions. Omontys is dosed once monthly, compared to ESAs such as Epogen or Procrit, that are dosed up to three times weekly.

New Guidelines For Acute Bacterial Sinusitis in Children and Adults

Viruses are responsible for the majority of sinus infections; antibiotics still continue to be prescribed at high rates Read More...

The Infectious Diseases Society of America (IDSA) has issued new evidence-based guidelines for the treatment of acute bacterial rhinosinusitis, emphasizing the appropriate clinical diagnosis of bacterial versus viral sinusitis and the prudent selection of antibiotics, if indicated. Sinusitis may develop during a cold or allergy flare-ups, cause painful facial pressure, and last for weeks. Over 90 percent of sinus infections are due to viruses, yet sinus infections continue to be the fifth highest reason to receive an antibiotic prescription. The same experts warn that haphazard use of antibiotics for viral sinus infections is leading to the expansion of highly drug-resistant bacteria, or “super-bugs”.

QNASL Now Approved For Allergic Rhinitis

QNASL (beclomethasone diproprionate) nonaqueous nasal aerosol available in April for seasonal and year-round allergies Read More...

Nasal corticosteroids are often the first drug of choice when treating allergic rhinitis symptoms such as a runny nose, watery eyes, and sneezing. But some patients do not tolerate the liquid nasal spray that may drip down the back of the throat. QNASL, a nonaqueous, or “dry” form of the nasal aerosol beclomethasone diproprionate, has been FDA-approved for seasonal and year-round allergic rhinitis. QNASL, the only nonaqueous allergic rhinitis corticosteroid available on the U.S. market, is approved for use in adults and adolescents 12 years and older. Four clinical trials demonstrated effectiveness of a 320-microgram dose delivered by two sprays in each nostril once daily. Teva Pharmaceuticals markets QNASL.

First-Time Generic Quetiapine Fumarate (Seroquel) Now Available

Teva Pharmaceuticals and Mylan Pharmaceuticals first to market generic formulation of Seroquel Read More...

Another billion-dollar blockbuster drug is now generic - Seroquel is now available from Teva Pharmaceuticals or Mylan Pharmaceuticals as quetiapine fumarate. AstraZeneca’s Seroquel had annual U.S. sales of $4.6 billion. Quetiapine, an atypical antipsychotic, is indicated for the treatment of schizophrenia, bipolar disorder, and as an adjunct to severe depression. Over the next several years, many blockbuster drugs will lose their patent protection with the potential to save the health care system billions of dollars. Examples of other blockbusters expected to go generic in 2012 include the blood thinner Plavix (clopidogrel, May 2012), the asthma and allergy preventative Singulair (montelukast, August 2012), and the diabetes treatment Actos (pioglitazone, August 2012).