Category Archives: Pediatrics

Sensipar Cinacalcet Hydrochloride Drug Safety Communication

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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

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Posted in Clinical Trials, Endocrinology, FDA 2013, FDA Safety Communication, Healthcare Professionals, Pediatrics | Tagged , , , , , , , , | Comments Off

GE Healthcare T-Piece Circuits Class I Recall

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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

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Posted in Emergency Rooms, FDA 2012, FDA Recall, Pediatrics, Risk Manager | Tagged , , , , , , | Comments Off

Natus Medical Incorporated Olympic Cool Cap System Class I Recall

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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

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Posted in FDA 2012, FDA Recall, OBGYN, Pediatrics, Risk Manager | Tagged , , , , , , , , , | Comments Off

Over-The-Counter Eye Drops and Nasal Sprays Drug Safety Communication

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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

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Posted in Consumer Products, FDA 2012, FDA Safety Communication, Pediatrics | Tagged , , , , , , | Comments Off

Revatio sildenafil Drug Safety Communication

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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

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Posted in Cardiology, FDA 2012, FDA Safety Communication, FDA Warning, Pediatrics, Pulmonology | Tagged , , , , , , , , , , , , | Comments Off

Codeine Use in Certain Children Drug Risks

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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

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Posted in Consumer Products, FDA 2012, FDA Safety Communication, FDA Warning, Pediatrics, Surgery | Tagged , , , , , , , , | Comments Off

Gerber Good Start Gentle Powdered Infant Formula Recall

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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

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Posted in Consumer Products, FDA 2012, FDA Recall, Pediatrics | Tagged , , , , , , , , , | Comments Off

Vitaflo USA Renastart Recall

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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

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Posted in Consumer Products, FDA Recall, Pediatrics | Tagged , , , , , , , | Comments Off

Over-the-Counter (OTC) Liquid acetaminophen FDA Notice

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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

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Posted in Consumer Products, FDA 2011, FDA Notice, Pediatrics, Pharmacy | Tagged , , , , , , , , , , , , | Comments Off