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Weekly Drug News Round Up - June 19, 2013

FDA: Two Patient Deaths Linked With Zyprexa Relprevv

While the FDA investigation is ongoing, health care professionals should follow the Zyprexa Relprevv REMS requirements Read More...

The U.S. Food and Drug Administration is investigating two unexplained deaths in patients who received an injection of the long-acting antipsychotic drug Zyprexa Relprevv (olanzapine pamoate). The patients died 3 to 4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS).  Both patients were found to have very high olanzapine blood levels after death. The Zyprexa Relprevv label contains warnings about the risk of post-injection delirium sedation syndrome (PDSS), a serious condition in which the drug enters the blood too fast following an intramuscular injection, causing high blood levels with sedation, coma and/or delirium.

Drug Interaction Between Common Antibiotics and Statins May Pose Risk

Macrolide antibiotics are often prescribed for lung infections such as pneumonia Read More...

Statins such as atorvastatin (Lipitor), simvastatin (Zocor) and lovastatin (Altoprev, Mevacor) are widely used medications prescribed to lower cholesterol levels. A study published in the Annals of Internal Medicine looked at more than 144,000 statin users 65 years of age or older who were taking the common macrolide antibiotics clarithromycin (Biaxin), erythromycin, or azithromycin (Zithromax). Both clarithromycin and erythromycin inhibit the metabolism (break down in the body) of these statins and can increase statin blood concentrations leading to serious muscle or kidney damage. However, azithromycin does not inhibit the metabolism of these statins and may be a safer macrolide antibiotic to help avoid muscle or kidney toxicity.

Xgeva Receives New Indication for Giant Cell Tumor of the Bone

Xgeva is a RANKL inhibitor monoclonal antibody intended for patients who are not surgical candidates for GCTB Read More...

The U.S. Food and Drug Administration has approved Xgeva (denosumab) for treatment of  Giant Cell Tumor of the Bone (GCTB), a rare and usually non-cancerous bone tumor. GCTB generally occurs in adults 20 to 40 years of age and destroys the normal bone. In clinical trials, 47 of 187 patients had a reduction in their tumor size after an average of three months, although 3 patients had regrowth of GCTB within 20 months. Xgeva is also indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

Quick Transport and Treatment Crucial for Stroke Victims

Rapid treatment with a clot-dissolving drug reduces stroke patients' risk of in-hospital death Read More...

In a new study published in the Journal of the American Medical Association, researchers looked at over 58,000 patients who suffered an ischemic stroke and were treated with tissue plasminogen activators (tPA) within four and a half hours of symptoms. Patients who were treated within 90 minutes of symptom onset were 26 percent less likely to die, 28 percent less likely to have a brain hemorrhage, 51 percent more likely to be able to walk, and 33 percent more likely to be discharged to home, compared to those with an onset-to-treatment time of 181 to 270 minutes.

Consumer Demand for Mobile Health on the Rise

Only one-quarter of people aged 65 and older were very interested in using the devices to help manage their blood pressure Read More...

In a Harris Interactive/HealthDay survey released this week, more than one-third of respondents said they were "very" or "extremely" interested in using smartphones or tablets. The online survey of 2,050 Americans aged 18 and older revealed respondents wanted to ask their doctors questions, make appointments, get medical test results, monitor their blood pressure or blood sugar, or even get a diagnosis via mobile health. In addition, 47 percent of those surveyed felt "somewhat confident" their online health information would be secure, but roughly 40 percent were "not very" or "not at all" confident about security.