Category Archives: FDA 2011

Is Avandia Worth The Risk?

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Is Avandia Worth The Risk? There has been several reported deaths from Avandia from heart attacks and strokes but meanwhile the FDA has refused to recall it. they have only recently updated their warnings about the increased risks to patients. … Continue reading

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Pradaxa (dabigatran etexilate mesylate) Drug Safety Communication

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Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events AUDIENCE: Cardiology, Pharmacy, Hematology ISSUE: FDA is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that … Continue reading

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Posted in Cardiology, FDA 2011, FDA Notice, FDA Warning, Hematology, Pharmacy | Tagged , , , , , , , , , | Comments Off

CooperVision Avaira Aquaform Sphere Soft Contact Lenses Class 1 Recall

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CooperVision Avaira Aquaform Sphere Soft Contact Lenses: Class 1 Recall – Unintended Residue on Lenses AUDIENCE: Eye Care, Consumer ISSUE: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Aquaform Sphere contact lenses. Symptoms … Continue reading

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Trilipix (fenofibric acid) Drug Safety Communication Label Change

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Trilipix (fenofibric acid): Drug Safety Communication – Label Change AUDIENCE: Family Practice, Cardiology, Pharmacy ISSUE: FDA notified healthcare professionals the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient’s risk of having a heart attack or stroke. FDA reviewed … Continue reading

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Tumor Necrosis Factor (TNF) blockers Azathioprine Mercaptopurine

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Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults   [UPDATED 11/04/2011]  Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers, and report … Continue reading

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Posted in FDA 2011, FDA Notice | Tagged , , , , , , , , , , | Comments Off

Sprycel (dasatinib) Drug Safety Communication

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Sprycel (dasatinib): Drug Safety Communication – Risk of Pulmonary Arterial Hypertension AUDIENCE: Hematology, Oncology ISSUE: FDA notified healthcare professionals that Sprycel (dasatinib) may increase the risk of a rare but serious condition in which there is abnormally high blood pressure … Continue reading

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Qualitest Pharmaceuticals Oral Contraceptives Recall

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Qualitest Pharmaceuticals Oral Contraceptives: Recall – Packaging Error includes Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20,  Orsythia, Previfem, Tri-Previfem   AUDIENCE: Consumer, Pharmacy, OB/GYN ISSUE: Qualitest Pharmaceuticals issued a nationwide, retail-level recall of multiple lots of … Continue reading

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Posted in Consumer Products, FDA 2011, FDA Recall, OBGYN, Pharmacy | Tagged , , , , , , , , , , , | Comments Off

Zofran (ondansetron) Drug Safety Communication

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Zofran (ondansetron): Drug Safety Communication – Risk of Abnormal Heart Rhythms AUDIENCE: Oncology, Anesthesiology ISSUE: FDA notified healthcare professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and generics). Ondansetron … Continue reading

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Posted in Anesthesiology, FDA 2011, FDA Label Change, FDA Warning, Oncology | Tagged , , , , , | Comments Off

Tumor Necrosis Factor-alpha (TNFα) Blockers Label Change

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Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change – Boxed Warning Updated for Risk of Infection from Legionella and Listeria including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab) AUDIENCE: Rheumatology, Gastroenterology, Oncology ISSUE: FDA notified healthcare … Continue reading

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Posted in FDA 2011, FDA Label Change, Gastroenterology, Oncology, Rheumatology | Tagged , , , , , , , | Comments Off

August 2011 Safety Labeling Changes

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August 2011 Safety Labeling Changes: 44 Medical Product Labels with changes to Prescribing Information The MedWatch August 2011 Safety Labeling Changes posting includes 45 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, … Continue reading

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