Recent FDA action (through September 2011) related to golimumab expanded label, meningococcal and Hib combination vaccine, desvenlafaxine, rivaroxaban anticoagulant, deferiprone oral iron chelator, glucarpidase experimental treatment, doxidopa, QLT091001, NP-001, cyclophosphamide, resminostat oral pan HDAC inhibitor, TXA127
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Labels for TNF-alpha blockers to warn of potential for infection
October 1st 2011In a safety communication released September 7, 2011, FDA announced it is requiring the prescribing information for all tumor necrosis factor-alpha blockers to include a black-boxed warning regarding an increased risk of infection from 2 bacterial pathogens, Legionella and Listeria.
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Certain DMARDs associated with an increased incidence of diabetes in patients with psoriasis or RA
October 1st 2011In patients with psoriasis or rheumatoid arthritis, the use of tumor necrosis factor inhibitors or hydroxychloroquine, but not methotrexate, was associated with a decrease in the incidence of diabetes compared to other disease-modifying antirheumatic drugs.
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Osteoporosis: A review of current recommendations and emerging treatment options
October 1st 2011Osteoporosis is a widespread condition with significant morbidity and mortality affecting millions of people in the United States and worldwide. Incidence is expected to increase as the population ages.
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NSAIDs increase miscarriage risk in early pregnancy
September 21st 2011Nonsteroidal anti-inflammatory drugs (NSAIDs) should be used with caution during pregnancy, as exposure may increase the risk of spontaneous abortion, reported a study published online September 6 in the Canadian Medical Association Journal.
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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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