FDA panel recommends approval of rivaroxaban for stroke prevention
September 9th 2011An FDA advisory panel voted 9-2 (with 1 abstention) to recommend approval for rivaroxaban (Xarelto, Johnson & Johnson and Bayer AG), an oral, once-daily anticoagulant as a treatment to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
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FDA approves antipsychotic haloperidol injection, USP
September 9th 2011FDA has approved an antipsychotic medication, haloperidol injection, USP (Sagent Pharmaceuticals), indicated for use in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette's disorder.
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FDA Mini-Sentinel pilot launches
September 9th 2011The first step toward a national electronic system that will transform FDA?s ability to track the safety of drugs, biologics, and medical devices is up and running, according to a recent press release announcing the Mini-Sentinel Pilot project.
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Hospital admission may lead patients to unintentionally discontinue medications for chronic diseases
September 9th 2011Patients discharged from the hospital are at an elevated risk of not continuing their long-term medications for chronic diseases, and ICU admission appears to further increase this risk, according a recent study published August 24 in the Journal of the American Medical Association.
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FDA acknowledges ongoing drug shortage, warns pharmacists of fraud
September 9th 2011Drugs such as Taxol, Cytarabine, Daunorubicin, Doxil, and Leucovorin are in short supply, delaying patients with various forms of cancer from getting the treatments they need or forcing them to seek alternative, possibly less-effective treatments, FDA announced recently.
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FDA Safety Alert: Abnormal heart rhythms associated with high doses of citalopram hydrobromide
September 2nd 2011FDA has notified healthcare professionals and patients that the antidepressant citalopram hydrobromide (Celexa, Forest Laboratories) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart.
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FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer
September 2nd 2011FDA has notified healthcare professionals and patients that the antidepressant citalopram hydrobromide (Celexa, Forest Laboratories) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart.
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Linaclotide reduces symptoms for patients with chronic constipation, studies show
September 2nd 2011Linaclotide, an investigational drug for the relief of chronic constipation, appears to be effective and safe, according to the results of two phase 3 trials published in the August issue of the New England Journal of Medicine.
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Study provides first evidence-based colchicine dosing recommendations
September 2nd 2011Colchicine, a widely used drug for the prevention and treatment of gout flares, interacts dangerously with many commonly prescribed pharmaceuticals, such as antibiotics, anti-hypertensive drugs, anti-fungals, immunosuppresants and protease inhibitors, according to a study published in the August issue of Arthritis & Rheumatism. However, most patients can take colchicines safely with these medications as long as the dose is adjusted, the study indicated.
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FDA approves tapentadol ER for management of moderate-to-severe chronic pain
September 2nd 2011FDA has approved tapentadol extended-release tablets (Nucynta ER, Janssen Pharmaceuticals), an oral analgesic taken twice daily, for the management of moderate-to-severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
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HRT reanalyses shows favorable risk-benefit profile with recommended treatment strategies
August 26th 2011The risk-benefit ratio is in favor of hormone replacement therapy (HRT) when initiated near menopause, according to new consensus statements issued by The North American Menopause Society, The American Menopause Society and the International Menopause Society and published in a recent paper in the July issue of Women?s Health.
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US healthcare system among least cost-effective in reducing mortality
August 26th 2011The United States healthcare system is one of the least cost-effective in reducing mortality rates; while the United Kingdom is among the most cost-effective, according to a recent study published in the July issue of Journal of the Royal Society of Medicine Short Reports.
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Once-daily rivaroxaban appears to be as effective as dose-adjusted warfarin
August 26th 2011Once-daily oral rivaroxaban (Xarelto, Bayer), a direct factor Xa inhibitor, appears to be as effective as dose-adjusted warfarin in preventing stroke or major embolism in patients with nonvalvular atrial fibrillation, according to a study published online August 10 in the New England Journal of Medicine.
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Children's dose-dependent CA-MRSA risk increases with antibacterial use
August 26th 2011Antibacterial drug use in children is associated with a dose-dependant increased risk of acquiring community-associated methicillin-resistant Staphylococcus aureus (Ca-MRSA), according to the results of a population-based, case-control study reported online August 1 in the Archives of Pediatrics & Adolescent Medicine.
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