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Monthly Archives: July 2011
Zyvox (linezolid) Drug Safety Communication
Translation Zyvox (linezolid): Drug Safety Communication – Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications AUDIENCE: Infectious Disease, Psychiatry, Family Practice ISSUE: FDA has received reports of serious central nervous system (CNS) reactions when the … Continue reading
Posted in Family Practice, FDA 2011, FDA Notice, Infectious Disease, Psychiatry
Tagged Drug Safety Communication, Family Practice, Infectious Disease, linezolid, Psychiatry, Zyvox
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Methylene Blue Drug Safety Communication
TranslationMethylene Blue: Drug Safety Communication – Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications AUDIENCE: Emergency Medicine, Critical Care Medicine, Psychiatry ISSUE: FDA has received reports of serious central nervous system (CNS) reactions when the … Continue reading
Posted in FDA 2011, FDA Notice, FDA Warning
Tagged Critical Care Medicine, Drug Safety Communication, Emergency Medicine, FDA notice, FDA warning, Methylene Blue, Methylene Blue Drug, Psychiatry, Safety Communication
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Multaq (dronedarone): Drug Safety Communication Increased Risk of Death or Serious Cardiovascular Events
TranslationMultaq (dronedarone): Drug Safety Communication – Increased Risk of Death or Serious Cardiovascular Events ISSUE: FDA notified healthcare professionals that it is reviewing data from a clinical trial that evaluated the effects of the antiarrhythmic drug Multaq (dronedarone) in patients … Continue reading
Posted in FDA 2011, FDA Warning
Tagged FDA warning, Increased Risk of Death, Multaq (dronedarone): Drug Safety Communication, Serious Cardiovascular Events
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Oral Osteoporosis Drugs (bisphosphonates)
TranslationOral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication – Potential Increased Risk of Esophageal Cancer Includes: Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate), Atelvia (risedronate delayed release), Didronel (etidronate), and Skelid (tiludronate) AUDIENCE: Geriatrics, Family Practice, Internal Medicine ISSUE: FDA notified healthcare … Continue reading
CardioGen-82 PET scan
TranslationAUDIENCE: Nuclear Medicine, Radiology, Patients ISSUE: FDA notified the public and the medical imaging community about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac positron emission tomography (PET) scans with rubidium (Rb)-82 … Continue reading
Posted in FDA 2011, FDA Warning
Tagged Bracco Diagnostics, CardioGen-82, FDA notice, FDA warning, manufactured, rubidium (Rb)-82 chloride injection
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Tamiflu (oseltamivir phosphate) for Oral Suspension
TranslationTamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL) AUDIENCE: Pediatrics, Pharmacy ISSUE: Labeling changes are being made to Tamiflu oral suspension to reduce the possibility of prescribing and dosing confusion that can lead to medication errors. The … Continue reading
Posted in FDA 2011, FDA Label Change, FDA Notice
Tagged FDA notice, safety label changes, Tamiflu, Tamiflu (oseltamivir phosphate) for Oral Suspension
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Nulojix (belatacept) Risk Evaluation and Mitigation Strategy (REMS)
TranslationNulojix (belatacept): Risk Evaluation and Mitigation Strategy (REMS) Increased Risk of Post-transplant Lymphoproliferative Disorder (PTLD), predominantly involving the Central Nervous System (CNS), and Progressive Multifocal Leukoencephalopathy (PML) AUDIENCE: Transplantation, Nephrology ISSUE: Bristol-Myers Squibb informed healthcare professionals about the REMS that … Continue reading
Posted in FDA 2011, FDA Warning
Tagged Nulojix (belatacept), Risk Evaluation and Mitigation Strategy (REMS)
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Valproate Products Drug Safety Communicaton
TranslationValproate Products: Drug Safety Communicaton – Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy) Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics AUDIENCE: OBGYN, … Continue reading
Tylenol Extra Strength Caplets, 225 count bottles Recall
TranslationTylenol Extra Strength Caplets, 225 count bottles: Recall – Uncharacteristic Odor AUDIENCE: Pharmacy, Consumer ISSUE: McNeil Consumer Healthcare is recalling one product lot of Tylenol Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recall stems from a … Continue reading
Posted in Consumer Products, FDA 2011, FDA Recall
Tagged 225 count bottles, Extra Strength Caplets, FDA recall, Recall, Tylenol
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Nature Relief Instant Wart and Mole Remover Recall
TranslationNature Relief Instant Wart and Mole Remover: Recall – Risk of Severe Skin Burns AUDIENCE: Consumer ISSUE: Nature Relief and FDA notified the public of a recall of Nature Relief Instant Wart and Mole Remover. FDA has advised that the … Continue reading
Posted in Consumer Products, FDA 2011, FDA Recall
Tagged FDA recall, Instant Wart, Mole Remover, Nature Relief, Recall
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