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Weekly News Round Up - October 26, 2011

Xigris Withdrawn Worldwide Due to Lack of Efficacy

FDA announces Xigris withdrawal due to lack of survival benefit in severe sepsis and septic shock Read More...

Eli Lilly has voluntarily withdrawn Xigris [drotrecogin alfa (activated)] from worldwide marketing. Xigris treatment should be discontinued in current patients and it should not be started in new patients. Xigris, indicated as treatment for severe sepsis associated with acute organ dysfunction and a high risk of death, recently failed to show survival benefit in severe sepsis and septic shock patients. Mortality rates were 26.4% in Xigris-treated patients compared to 24.2% in the placebo group and did not result in a statistically significant survival between groups.

Onfi (clobazam) Approved as Adjunctive Therapy for Seizures

FDA approves Onfi (clobazam) as adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome Read More...

Onfi (clobazam), a GABA receptor-binding benzodiazepine for seizures associated with Lennox-Gastaut Syndrome, received approval from the FDA this week. Onfi efficacy was confirmed in two multi-center, controlled trials in patients two years of age and older. Studies looked at the reduction in the weekly frequency of atonic, tonic, or myoclonic seizures. In both studies, patients had statistically improved seizure management compared to controls. Onfi is an oral schedule IV controlled substance that may lead to somnolence, impaired motor skills, abuse and dependence. The drug should be discontinued slowly to avoid seizure precipitation or withdrawal symptoms.

National Prescription Drug Take Back Day, October 29, 2011

Safely rid your home of unused medications this Saturday, October 29th at local drop off locations nationwide Read More...

Let’s face it: we all keep those prescription bottles of unused and expired drugs stashed way in the back of our cabinets - an accident just waiting to happen. Safely clear out those bottles this Saturday when local communities team up with law enforcement to host the third Drug Enforcement Agency (DEA) National Prescription Drug Take Back Day. Free and safe medication disposal will be available nationwide this Saturday from 10 AM until 2 PM - with no questions asked. Drug disposal at local community sites will help to decrease the chances that expired or unused drugs get into the hands of the wrong person, will safeguard children and pets, and can provide an environmentally friendly answer to neglected unused medications.

FDA Updates Serotonergic Drug Interactions with Zyvox (linezolid) or Methylene Blue

Use of linezolid or methylene blue associated with serotonergic interactions primarily with SSRI and SNRI drug classes Read More...

Not all psychiatric serotonergic drugs are created equal. FDA has issued updates to previous Drug Safety Communications warning that serotonergic drug interactions occurring with either Zyvox (linezolid) or methylene blue occur primarily with the drug classes of selective serotonin reuptake inhinbitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). Serotonin Syndrome is a serious central nervous system disorder that may result in mental changes, sweating, muscle twitching, fever and lack of coordination. It is not known if other drugs with lesser degrees of serotonergic activity pose a similar risk. A list of interacting drugs and drug usage recommendations can be found in the FDA Drug Safety Communication.

Letrozole Outperforms Tamoxifen in Breast Cancer Study

Study confirms letrozole monotherapy should be considered first-line adjuvant in postmenopausal breast cancer survivors Read More...

Femara (letrozole) monotherapy compared to tamoxifen monotherapy results in a lower risk of breast cancer recurrence and dying in women treated for postmenopausal, estrogen receptor-positive early breast cancer. A team of researchers from the U.S., Europe and Australia published the results this week in The Lancet Oncology. Researchers noted the women had used adjuvant letrozole therapy for an average of 5 years after breast cancer treatment. Sequential treatment with tamoxifen followed by letrozole, or in reverse order, did not lead to similar results. Women who are breast cancer survivors should always discuss the best treatment options with their physician. Tamoxifen still may be the best agent for some women, based on tolerability. An added bonus - letrozole is now available generically and may be affordable for many women; tamoxifen is available generically, as well.

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