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Weekly Drug News Round Up - June 5, 2013

Bloxiverz Okayed as First FDA-Approved Version of Neostigmine

Atropine or glycopyrrolate should be administered prior to Bloxiverz to minimize the risk of slow heart rate Read More...

Neostigmine is an acetylcholinesterase inhibitor used to reverse the effects of neuromuscular blockers such as atracurium (Tracrium) or vecuronium (Norcuron). The U.S. Food and Drug Administration has now for the first time approved neostigmine (Bloxiverz) made by Flamel Technologies. All other versions of neostigmine are unapproved, grandfathered products under the Food, Drug and Cosmetic Act of 1938. Neuromuscular blocking agents are used with anesthesia, only when artificial ventilation is available, to produce muscle relaxation in order to prevent muscle movement during surgery. Neostigmine increases synaptic acetylcholine levels to reverse this neuromuscular blockade at the completion of surgery. Acetylcholinesterase inhibitors similar to neostigmine include edrophonium and pyridostigmine.

FDA Limits Magnesium Sulfate Use in Preterm Labor

Pregnant women should talk with their doctor about pre-term labor and the risks and benefits of any treatments Read More...

The U.S. Food and Drug Administration is advising health care providers that use of magnesium sulfate injection for more than 5 to 7 days to stop preterm labor may lead to low calcium levels, thin bones (osteopenia), and fractures in the developing baby. The Magnesium Sulfate Injection, USP 50% labeling will be updated with the new warning. In addition, the pregnancy category will be changed from A to D, meaning there is positive evidence of human fetal risk, but the potential benefits of the drug may outweigh the risk. A new Labor and Delivery section will also emphasize that continuous magnesium sulfate injection to treat preterm labor is not an approved indication.

Aspirin Equals Pricier Blood Thinner After Hip Surgery: Study

Aspirin may be considered a reasonable alternative for clot prophylaxis after total hip replacement Read More...

A study published in the Annals of Internal Medicine confirms that the use of low-cost aspirin, which has blood-thinning action, instead of the more expensive options may be just as useful in clot prevention. After hip replacement surgery, patients are at risk for serious blood clots. Blood thinners (anticoagulants) are prescribed after surgery to help prevent these blood clots. Low molecular weight heparins such as injectable dalteparin (Fragmin) or the oral pill rivaroxaban (Xarelto) may be used, but are expensive. The effectiveness of aspirin use was found to be equivalent to dalteparin after an initial 10 days of clot prophylaxis with dalteparin.

Prescription Drug Poisoning in Kids on the Rise

As the number of adults taking prescription drugs has grown, so has the number of children being accidentally poisoned by them Read More...

As reported in Pediatrics, researchers evaluated National Poison Data System surveys from 2000 through 2009 to track poisoning from prescription drugs among infants to 5-year-olds, children aged 6 to 12 and teens aged 13 to 19. They specifically looked at poisoning from diabetes, high cholesterol, high blood pressure, and narcotic pain medications. Young children had the greatest risk of being poisoned by diabetes (60.2 percent) and blood pressure (59.7 percent) medicines. Narcotics and diabetes treatments caused the most serious injuries and hospitalizations.

Consumers Encouraged to Report Problems to FDA's MedWatch

Consumers have always been able to report problems to the FDA, but the focus was more on health care provider reporting Read More...

MedWatch is the Food and Drug Administration's (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-regulated products. Consumers who report problems can help identify unknown medical risks that may result in changes in use of medications and devices. The FDA is encouraging consumers to take part in reporting problems, and has designed a less technical form for reports. Additionally, MedWatchLearn, a new web-based learning tool, will be used to teach students in medical, pharmacy and nursing schools to fill out MedWatch reports and encourage others to do so.

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