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Category Archives: FDA Notice
Pradaxa dabigatran etexilate mesylate Drug Safety Communication
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves AUDIENCE: Cardiology, Patient ISSUE: The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the … Continue reading
Posted in Cardiology, FDA 2012, FDA Notice, FDA Warning, Patients
Tagged dabigatran etexilate mesylate, Drug Safety Communication, Pradaxa, Pradaxa (dabigatran etexilate mesylate) Drug Safety Communication
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St Jude Medical Riata Implantable Cardioverter Defibrillator ICD Leads
St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication – Premature Insulation Failure [Posted 08/16/2012] AUDIENCE: Cardiology, Radiology, Surgery, Family Practice ISSUE: The Food and Drug Administration (FDA) is providing information and recommendations regarding safety concerns with the … Continue reading
Posted in Cardiology, Family Practice, FDA 2012, FDA Notice, Radiology, Surgery
Tagged Cardiology, Cardioverter Defibrillator, drug risks, Family Practice, FDA notice, ICD Leads, Implantable, Radiology, St Jude Medical Riata, St Jude Medical Riata Implantable Cardioverter Defibrillator ICD Leads, Surgery
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Zithromax azithromycin FDA Drug Risks
Zithromax (azithromycin): FDA Statement on risk of cardiovascular death Read the MedWatch safety alert, including a link to the Drug Safety Communication at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304503.htm Audience: Primary Care, Pharmacy ISSUE: FDA notified healthcare professionals that it is aware of the study … Continue reading
Posted in Cardiology, FDA 2012, FDA Notice, Pharmacy
Tagged azithromycin, FDA Drug Risks, Zithromax, Zithromax azithromycin FDA Drug Risks
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Victrelis and Ritonavir Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs Drug Safety Communication
Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication – Drug Interactions AUDIENCE: Infectious Disease, Pharmacy ISSUE: FDA notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis … Continue reading
Posted in FDA 2012, FDA Notice, FDA Safety Communication, Infectious Disease, Pharmacy
Tagged drug risks, Drug Safety Communication, FDA notice, FDA warning, Human Immunodeficiency Virus (HIV), Protease Inhibitor Drugs, Victrelis (boceprevir) and Ritonavir-Boosted, Victrelis and Ritonavir Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs
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Proton Pump Inhibitors PPIs Drug Safety Communication
Proton Pump Inhibitors (PPIs) – Drug Safety Communication: Clostridum Difficile-Associated Diarrhea (CDAD) Can be Associated With Stomach Acid Drugs AcipHex (rabeprazole sodium) Dexilant (dexlansoprazole) Nexium (esomeprazole magnesium) Omeprazole (omeprazole) Over-the-Counter (OTC) Prevacid (lansoprazole) and OTC Prevacid 24hr Prilosec (omeprazole) and … Continue reading
Posted in Consumer Products, Family Practice, FDA 2012, FDA Notice, FDA Safety Communication, FDA Warning, Gastroenterology
Tagged Aciphex, Dexilant, drug risks, Drug Safety Communication, FDA notice, FDA Safety Communication, FDA warning, Nexium, Omeprazole, Prevacid, Prilosec, Proton Pump Inhibitors PPIs, Proton Pump Inhibitors PPIs Drug Safety Communication, PRotonix, safety label changes, stomach acid reducers, Vimovo, Zegerid
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Tysabri (natalizumab) Drug Safety Communication
Tysabri (natalizumab): Drug Safety Communication – New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML) AUDIENCE: Neurology, Gastroenterology ISSUE: FDA notified healthcare profesisonals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal … Continue reading
Adcetris (brentuximab vedotin) Drug Safety Communication
Adcetris (brentuximab vedotin): Drug Safety Communication – Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity AUDIENCE: Oncology, Hematology, Neurology ISSUE: FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in … Continue reading
Posted in FDA 2011, FDA Label Change, FDA Notice, FDA Warning, Hematology, Neurology, Oncology
Tagged Adcetris, Adcetris (brentuximab vedotin) Drug Safety Communication, brentuximab vedotin, drug risks, Drug Safety Communication, FDA notice, FDA warning, Progressive Multifocal Leukoencephalopathy, Pulmonary Toxicity, safety label changes
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Over-the-Counter (OTC) Liquid acetaminophen FDA Notice
Liquid Acetaminophen Concentration FDA Notice AUDIENCE: Pediatrics, Consumers, Pharmacy ISSUE: The FDA is informing the public that an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available. This change in the concentration will affect the … Continue reading
Posted in Consumer Products, FDA 2011, FDA Notice, Pediatrics, Pharmacy
Tagged Children Medicines, Drug Safety Communication, FDA notice, Infant/Pain Reliever, Liquid acetaminophen, Little Fevers, Over-the-Counter (OTC), Over-the-Counter (OTC) Liquid acetaminophen, Pedia Care, safety label changes, Triaminic, Triaminic Infants’ Syrup Fever Reducer Pain Reliever, Tylenol
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Gilenya (fingolimod) Drug Safety Communication
Gilenya (fingolimod): Drug Safety Communication – Safety Review of a Reported Death After the First Dose AUDIENCE: Neurology, Patients ISSUE: The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking … Continue reading
Posted in FDA 2011, FDA Notice, multiple sclerosis (MS), Neurology
Tagged Drug Safety Communication, FDA notice, Gilenya (fingolimod), Gilenya (fingolimod) Drug Safety Communication, multiple sclerosis (MS), Neurology
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Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants Drug Safety Communication
Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication – Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn Including Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, … Continue reading
Posted in Family Practice, FDA 2011, FDA Notice, OBGYN, Psychiatry
Tagged (SSRI), Antidepressants, Celexa (citalopram), Dietary Supplements, Drug Safety Communication, Family Practice, FDA notice, Lexapro (escitalopram), Luvox, Luvox CR (fluvoxamine), OBGYN, Paxil, Paxil CR, Pexeva (paroxetine), Prozac, Psychiatry, Sarafem, Selective Serotonin Reuptake Inhibitor, Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants, Symbyax (fluoxetine), Viibryd (vilazodone), Zoloft (sertraline)
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