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Category Archives: Pediatrics
Sensipar Cinacalcet Hydrochloride Drug Safety Communication
Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication – FDA Suspends Pediatric Clinical Trials After Report Of Death AUDIENCE: Health Professional, Endocrinology, Pediatrics ISSUE: FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after the recent death of … Continue reading
Posted in Clinical Trials, Endocrinology, FDA 2013, FDA Safety Communication, Healthcare Professionals, Pediatrics
Tagged 14 year old death, chronic kidney disease, Cinacalcet Hydrochloride, Clinical Trials, drug risks, Drug Safety Communication, FDA recall, Sensipar, Sensipar Cinacalcet Hydrochloride Drug Safety Communication
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GE Healthcare T-Piece Circuits Class I Recall
GE Healthcare T-Piece Circuits for the Giraffe and Panda Resuscitation Systems: Class I Recall – Failure to Achieve the Desired Inspiratory Pressure During Ventilation AUDIENCE: Emergency Medicine, Pediatrics, Risk Manager ISSUE: The disposable T-piece circuits do not achieve the maximum … Continue reading
Posted in Emergency Rooms, FDA 2012, FDA Recall, Pediatrics, Risk Manager
Tagged Class I Recall, Emergency Medicine, GE Healthcare, GE Healthcare T-Piece Circuits Class I Recall, Pediatrics, Risk Manager, T-Piece Circuits
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Natus Medical Incorporated Olympic Cool Cap System Class I Recall
Natus Medical Incorporated, Olympic Cool-Cap System: Class I Recall – Control Screen Freezes During Treatment AUDIENCE: Risk Manager, OB/GYN, Pediatrics ISSUE: FDA notified healthcare professionals of a Class I Recall of the Olympic Cool-Cap System, because the device’s Control Module … Continue reading
Over-The-Counter Eye Drops and Nasal Sprays Drug Safety Communication
Over-The-Counter Eye Drops and Nasal Sprays: Drug Safety Communication – Serious Adverse Events From Accidental Ingestion by Children AUDIENCE: Pediatrics, Consumer ISSUE: FDA is warning healthcare professionals and the public that accidental ingestion by children of over-the-counter eye drops used to … Continue reading
Revatio sildenafil Drug Safety Communication
Revatio (sildenafil): Drug Safety Communication – Recommendation Against Use in Children AUDIENCE: Pediatrics, Cardiology, Pulmonology ISSUE: FDA notified healthcare professionals and their medical care organizations that Revatio (sildenafil) should not be prescribed to children (ages 1 through 17) for pulmonary … Continue reading
Posted in Cardiology, FDA 2012, FDA Safety Communication, FDA Warning, Pediatrics, Pulmonology
Tagged Cardiology, drug risks, Drug Safety Communication, FDA warning, PAH, Pediatrics, pulmonary arterial hypertension, Pulmonology, Revatio, Revatio sildenafil Drug Safety Communication, safety label changes, Safety Labeling Changes, sildenafil
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Codeine Use in Certain Children Drug Risks
Codeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy: Drug Safety Communication – Risk of Rare, But Life-Threatening Adverse Events or Death AUDIENCE: Pediatricians, Surgery, Consumer ISSUE: The FDA is reviewing reports of children who developed serious adverse effects or … Continue reading
Gerber Good Start Gentle Powdered Infant Formula Recall
Gerber Good Start Gentle Powdered Infant Formula: Recall – Off-Odor AUDIENCE: Consumers, Pediatrics ISSUE: Gerber notified the public that it recalled one lot of Gerber Good Start Gentle Powdered Infant Formula, 23.2 ounce plastic package, because the affected product might … Continue reading
Posted in Consumer Products, FDA 2012, FDA Recall, Pediatrics
Tagged Consumer Products, drug, FDA recall, Gentle Powdered, Gerber, Gerber Good Start Gentle Powdered Infant Formula Recall, Good Start, Infant Formula, Pediatrics, Recall
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Vitaflo USA Renastart Recall
Vitaflo USA Renastart: Recall – Possible Health Risk Due To Incorrectly Labeled Cans AUDIENCE: Pediatrics, Health Professionals, Consumers ISSUE: Vitaflo USA has announced a voluntary recall of Renastart 14.11 oz (400g) cans, Batch Number 12832, because some of the product … Continue reading
Posted in Consumer Products, FDA Recall, Pediatrics
Tagged Consumers, drug risks, FDA recall, Pediatrics, Recall, Renastart, Vitaflo USA, Vitaflo USA Renastart Recall
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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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