FDA Approvals & Safety Updates

• FDA Panel: Upper Airway Device Beneficial for OSA
  Medscape Education Clinical Briefs April 15, 2014
  FDA Approval: Upper Airway Device Beneficial for OSA
  
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• FDA Approval: Dapagliflozin for Type 2 Diabetes
  Medscape Education Clinical Briefs January 27, 2014
  The FDA has approved dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, but safety concerns persist.
  
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• FDA Safety Communication: Clobazam Linked With Serious Skin Reactions
  Medscape Education Clinical Briefs December 24, 2013
  The FDA warns that clobazam, used to treat seizure disorders, may cause serious and potentially fatal skin reactions of Stevens-Johnson syndrome and toxic epidermal necrolysis.
  
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• FDA Safety Alert: Reduce Operative Bleeding Risk in Patients Taking LMWHs
  Medscape Education Clinical Briefs November 26, 2013
  The FDA offers recommendations to lower spinal column bleeding risk after spinal intervention, including epidural procedures and lumbar puncture, in patients taking low-molecular-weight heparins.
  
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• FDA Safety Change: Antiseizure Drug Linked With Eye, Skin Abnormalities
  Medscape Education Clinical Briefs November 25, 2013
  A boxed warning for ezogabine warns of risks for retinal abnormalities; adverse events of vision loss and skin discoloration, all of which may be permanent, are also highlighted.
  
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• FDA Safety Change: Blood Clots Reported With Use of Leukemia Drug
  Medscape Education Clinical Briefs November 20, 2013
  The FDA has requested that the leukemia drug ponatinib be withdrawn from the market because of safety concerns including potentially life-threatening thrombotic complications.
  
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• FDA Approval: Ferric Carboxymaltose for Iron-Deficiency Anemia
  Medscape Education Clinical Briefs November 18, 2013
  The FDA has approved the first high-dose, nondextran ferric carboxymaltose injection for the treatment of iron-deficiency anemia in a broad adult population.
  
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• FDA Approval: Pertuzumab for Neoadjuvant Treatment of Breast Cancer
  Medscape Education Clinical Briefs October 28, 2013
  For the first time, the US Food and Drug Administration has approved pertuzumab to be used in combination with other medications in patients with early-stage breast cancer.
  
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• FDA Safety Change: Tigecycline Strongly Linked With Mortality Risk
  Medscape Education Clinical Briefs October 22, 2013
  The US Food and Drug Administration has announced an increased risk for death with the antibiotic tigecycline, which therefore should be used as a last resort to treat severe infections.
  
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• FDA Approval: Dolutegravir for HIV-1 Infection
  Medscape Education Clinical Briefs September 17, 2013
  The US Food and Drug Administration has approved dolutegravir, an integrase strand transfer inhibitor, as an adjunct to other antiretroviral drugs for treatment of adults and children with HIV-1.
  
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• FDA Safety Change: Risk for Neuropathy With Fluoroquinolone Use
  Medscape Education Clinical Briefs September 17, 2013
  
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• FDA Approval: Meningococcal Vaccine Now Approved for Infants and Toddlers
  Medscape Education Clinical Briefs August 28, 2013
  
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• FDA Safety Changes: Ketoconazole Linked With Liver Injury
  Medscape Education Clinical Briefs August 23, 2013
  The FDA has announced that oral ketoconazole should not be given first line to treat any fungal infection because of the risk for severe liver damage, along with adrenal injury.
  
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• FDA Approvals: Plasma-Derived Agent for Anticoagulation Reversal
  Medscape Education Clinical Briefs July 22, 2013
  Human prothrombin complex concentrate has been approved for reversal of vitamin K antagonist anticoagulation to treat acute bleeding, particularly in patients who receive long-term anticoagulation.
  
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• FDA Approvals: Dabrafenib and Trametinib for Metastatic Melanoma
  Medscape Education Clinical Briefs July 16, 2013
  The US Food and Drug Administration has approved 2 orally available drugs for treatment of metastatic melanoma linked with the V600E or V600K BRAF mutation.
  
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• FDA Approvals: New Combo Inhaled Treatment of COPD
  Medscape Education Clinical Briefs July 11, 2013
  The US Food and Drug Administration has approved a new once-daily combination powdered inhaler to treat moderate and severe exacerbations of chronic obstructive pulmonary disease.
  
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• FDA Approvals: Radium-223 for Advanced Prostate Cancer
  Medscape Education Clinical Briefs July 03, 2013
  The US Food and Drug Administration has approved a radiopharmaceutical drug that targets bone metastases in symptomatic metastatic castration-resistant prostate cancer.
  
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• FDA Safety Changes: Use of Magnesium Sulfate to Stop Preterm Labor
  Medscape Education Clinical Briefs June 28, 2013
  The FDA warns that clinicians should not administer magnesium sulfate to pregnant women for more than 5 to 7 days to stop preterm labor because of associations with abnormalities in the fetus.
  
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• FDA Approvals: Efavirenz Expanded to Young Children With HIV
  Medscape Education Clinical Briefs June 18, 2013
  The FDA has expanded the approval of the non-nucleoside reverse transcriptase inhibitor efavirenz to children as young as 3 months infected with HIV.
  
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• FDA Safety Changes: Valproate Use During Pregnancy
  Medscape Education Clinical Briefs May 31, 2013
  The US Food and Drug Administration strengthened its warning on valproate use in pregnant women with migraine, stressing that fetal exposure to the drug may yield reduced IQ scores in children.
  
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