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Weekly Drug News Round Up - May 23, 2012

Levemir Indications Are Expanded for Younger Children with Type 1 Diabetes

Levemir now FDA-approved for use in pediatric type 1 diabetes from age two through five Read More...

Levemir (insulin detemir [rDNA origin] injection) is a basal insulin analog approved for use in adults with type 1 or type 2 diabetes, and in children older than 5 years of age with type 1 diabetes. The U.S. Food and Drug Administration (FDA) has now approved Levemir in pediatric type 1 diabetic patients two to five years of age. Studies showed that Levemir was as effective as NPH insulin, both keeping mean hemoglobin A1c, a measure of glucose control, below the recommended 8.5 percent in this age group. Levemir is the first basal insulin analog available for young children, who because of their age are at higher risk of diabetes complications such as severe hypoglycemia.

Increased Risk for Femur Fracture with Bisphosphonates

Additional research strengthens bisphosphonates association with atypical femur fractures Read More...

Osteoporosis drugs act to prevent bone fractures and associated morbidity, especially in older women. However, additional research is now strengthening an ironic warning that exists for a class of osteoporosis drugs known as bisphosphonates: that low trauma atypical femur fractures may rarely occur in women using these drugs. Bisphosphonates are a class of osteoporosis drugs that include Actonel (risedronate) and Fosamax (alendronate). Researchers found a statistically significant association between the use of bisphosphonates and atypical femur formation, which is a type of fracture that occurs spontaneously without any prior trauma or injury. However, researchers note the overall benefit of bisphosphonates outweighs the risk, and no absolute cause-and effect relationship was shown in the study.

Buffered Pancrelipase Product Pertzye Now Approved

Pancrelipase agent for treatment of exocrine pancreatic insufficiency due to cystic fibrosis okayed Read More...

Pertzye (pancrelipase) delayed-release capsules have been approved by the U.S. Food and Drug Administration (FDA). Pertzye is a combination of porcine-derived lipases, proteases, and amylases indicated for treatment of exocrine pancreatic insufficiency (EPI) in cystic fibrosis or other conditions. Pertzye is unique compared to many available pancrelipase products, because it consists of bicarbonate-buffered enteric-coated microspheres intended to minimize drug inactivation in the stomach acid. This is important because pancreatic enzymes are not absorbed from the gastrointestinal tract in appreciable amounts. The most common (>10%) side effects with Pertzye are diarrhea, heartburn and cough.

Zithromax Antibiotic Associated With Rare Cardiovascular Death: Study

Macrolide antibiotic labels already contain heart risks, QT interval prolongation warnings Read More...

Healthcare providers who treat patients with high risk heart disease or abnormal heart rhythms may reconsider the use of Zithromax (azithromycin). A Vanderbilt University cohort study published in the New England Journal of Medicine suggests that the risk of death with a 5-day treatment of azithromycin was more than double compared to amoxicillin or no drug treatment. However, the overall risk of death was very low. The results suggest there would be 47 extra heart-related deaths per 1 million courses of azithromycin treatment. The risk of cardiovascular death was also significantly greater when azithromycin was compared to ciprofloxacin use, but did not differ significantly with levofloxacin. The US Food and Drug Administration is updating risk information in the drug labels for additional macrolide antibiotics.

Plavix Patent Expires and Generic Clopidogrel Approved

Experts predict adherence rates will increase; preventable cardiovascular events will decrease Read More...

Sales of the brand name blockbuster Plavix (clopidogrel) exceeded $9 billion in 2011. Plavix is a widely used antiplatelet drug used to help prevent major cardiovascular events such heart attacks, strokes, and clot formation during certain procedures, such as stent placement. The monthly Plavix fee for patients without insurance ran close to $200, but the price is expected to drop drastically now that the patent has expired and the generic version is approved. Newer antiplatelet drugs such as Effient and Brilinta may be preferred for some patients. Multiple manufacturers, including Teva, Mylan and Roxane will be marketing the 75 or 300 milligram clopidogrel tablets.