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Weekly Drug News Round Up - September 9, 2015

Novel Aspirin Formulation Durlaza Is FDA-Approved 

Durlaza, like immediate-release aspirin, increases the risk of bleeding, gastric ulceration, and fetal harm in pregnancy Read More...

Low-dose aspirin has been a go-to agent to help prevent the reoccurrence of a stroke, heart attack, or other cardiovascular events; it is a standard-of-care therapy. This week, the U.S. Food and Drug Administration (FDA) approved Durlaza (aspirin), 24-hour, Extended Release Capsules, (162.5mg) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack). Immediate-release aspirin only extends antiplatelet action for roughly 4 to 6 hours. Durlaza has the ability to prolong aspirin release and platelet inhibition over 24 hours via an extended-release technology.

AstraZeneca’s Brilinta Gains New Indication, Dose

Brilinta 60 mg tablet is expected to be available in pharmacies by the end of September Read More...

The US Food and Drug Administration (FDA) has approved Brilinta (ticagrelor) tablets at a new 60 milligram (mg) dose to be used in patients with a history of heart attack beyond the first year. With this expanded indication, Brilinta is now approved to reduce the rate of cardiovascular death, heart attack (myocardial infarction, MI) and stroke in these patients. In the management of acute coronary syndrome (ACS), the recommended maintenance dose of Brilinta is 90 mg twice daily during the first year after the ACS event. After one year, patients with a history of heart attack can now be treated with Brilinta 60 mg twice daily.

FDA Approves Xuriden For Rare Hereditary Orotic Aciduria

No side effects were observed in patients treated with Xuriden for up to nine months Read More...

Hereditary orotic aciduria is an extremely rare, pediatric metabolic disorder, which has been reported in roughly 20 patients worldwide. The U.S. Food and Drug Administration has approved orphan drug Xuriden (uridine triacetate), an orally administered uridine replacement product for the treatment of patients with hereditary orotic aciduria. An enzyme abnormality prevents adequate synthesis of uridine, needed by ribonucleic acid (RNA). Symptoms include blood abnormalities, urinary tract obstruction, failure to thrive and developmental delays. Xuriden, given once daily, is approved as oral granules that can be mixed with food or in milk or infant formula.

Emend Wins Expanded Use in Younger Age Group

Common side effects in clinical trials included headache, cough, fatigue, dizziness and hiccups Read More...

Emend (aprepitant), an NK1 receptor antagonist, has a new FDA-approved use in pediatric groups. Emend is now indicated for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy (HEC) or moderately emetogenic cancer chemotherapy (MEC) in patients 12 years of age and older and less than 12 years of age who weigh at least 30 kilograms (kg). In clinical trials, 49 and 56 percent of patients had a complete response with Emend compared to 19 and 38 percent in the control group, for the delayed and acute phases of chemotherapy-induced nausea and vomiting (CINV), respectively.

ER Visits Declining For Accidental Drug Overdoses in Kids

CDC researchers found that 91 percent of emergency room (ER) visits involved ingestion of just one medicine Read More…

Tamper-proof packaging and expanded warnings to parents seem to be lowering rates of accidental drug poisonings in kids. Overdose emergency room visits peaked at roughly 76,000 in 2010, but declined to approximately 59,000 visits in 2013, according to CDC. Researchers found that four common medications - acetaminophen (Tylenol), cough and cold meds, like Delsym or Robitussin, ibuprofen (Motrin, Advil) and the antihistamine diphenhydramine (Benadryl) - caused 91 percent of ER visits for over-the-counter liquid medication exposures. The most common prescription drug class involved in pediatric overdoses was narcotics for pain, such as buprenorphine, oxycodone or hydrocodone.

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