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Weekly News Round Up - January 4, 2011

Prevnar 13 Approved for Adults 50 and Over For Pneumonia Prevention

Prevnar 13 shown to induce antibody levels similar to or better than current vaccine approved in this age group Read More...

Prevnar 13 (pneumococcal valent-13 vaccine) has been FDA-approved to prevent pneumonia and invasive pneumococcal disease in adults 50 years and older. Invasive disease includes blood (bacteremia) or spinal tissue (meningitis) infection with Streptococcus pneumoniae, the bacterium that infects the lungs and leads to pneumococcal pneumonia. Multi-center trials have shown Prevnar 13 leads to antibody levels equal to or higher than those produced by Pneumovax 23. Prevnar 13 is also approved for use in children six weeks through 5 years of age for prevention of otitis media and invasive Streptococcus pneumoniae disease caused by certain strains. Prevnar 13 side effects were similar to those seen with Pneumovax 23 and included injection site reactions, fatigue, headache, chills and muscle pain.

Berinert Approved for Self-Administration in Hereditary Angioedema 

Expanded approvals include treatment of life-threatening laryngeal attacks, home intravenous infusion self-administration Read More...

Hereditary angioedema (HAE) is a rare and sometimes fatal genetic disorder due to a deficiency of complement C1 esterase inhibitor (C1-INH). HAE results in swelling of the face, abdomen or voice box (larynx) and requires rapid treatment. Berinert (complement C1 esterase inhibitor), previously approved for treatment of acute abdominal or facial swelling of HAE, is now also approved for treatment of life-threatening laryngeal swelling. With proper training, patients may also self-administer Berinert at home via intravenous infusion. A delay in HAE treatment may result in patient hospitalization and poor outcomes, so quick administration at home may avert health care costs and save lives.

High Suicide Risk: Abusers of IV Methamphetamine

Intravenous abuse of methamphetamine associated with a higher risk of suicide; gives clues about how to strategize treatment Read More...

Research has shown that intravenous (IV) methamphetamine (meth) drug users are eighty percent more likely to attempt suicide than those who abuse other drugs. Researchers from Columbia University and the University of British Columbia suggest the increased risk might be from a mixture of social, structural and neurobiological factors, with IV meth abusers having a weaker social support system. Interviews were conducted with over 1,900 men and women in the Vancouver area, an area known to have one of the largest concentrations of IV drug abusers in North America. Eight percent of users were found to have previously attempted suicide. Researchers propose substance abuse programs for meth users should include suicide risk assessment and prevention efforts.

Tamiflu-Resistant Influenza Reported in Australia

Resistant pandemic 2009 A(H1N1) strains identified in southern hemisphere flu season Read More...

Our friends down under are now comfortably enjoying warm summer temperatures, just as winter and flu season peaks in the U.S. But experts report in the New England Journal of Medicine that a Tamiflu (oseltamivir)-resistant viral strain appeared in Australia in their most recent winter, May through August of 2011. Patients exhibited Tamiflu resistance to the pandemic 2009 A(H1N1) flu strain (swine flu). Researchers obtained viral samples from 182 H1N1 flu patients, and 16 percent were found to be resistant to Tamiflu, rimantadine, and amantadine. Although Relenza (zanamivir) remained sensitive and a treatment option, antiviral therapy must be started within 24 to 48 hours of symptom onset to be effective. The advent of resistant 2009 A(H1N1) flu strains emphasizes the continued need for preventative flu vaccination.

CYP2C19 Genotyping in Question For Plavix

Contrary to the boxed warning, recent study suggests CYP2C19 genotyping may not be needed for Plavix Read More...

A controversial study published in the Dec. 28 issue of the Journal of the American Medical Association refutes the current boxed warning on the product label for the blood thinner Plavix (clopidogrel). Clopidogrel is a prodrug that requires conversion to its active metabolite by certain cytochrome (CYP) P450 enzymes, primarily the CYP2C19 enzyme. The boxed warning states that some patients are “poor metabolizers”, meaning they have low activity of the 2C19 enzyme. Reduced 2C19 activity may prevent conversion to the active form of clopidogrel and lower blood thinning effectiveness. In the systematic review and meta-analysis, the authors suggest that genetic testing to identify poor metabolizers prior to clopidogrel therapy may not improve the effect of clopidogrel on cardiovascular endpoints, with the possible exception of stent thrombosis. Still, other experts say a randomized, controlled trial will be needed to determine the need for genotyping.