Category Archives: Hematology

Soliris (Eculizumab) Concentrated Solution Alexion Recall

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Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall – Visible Particles AUDIENCE: Hematology, Pharmacy ISSUE: Alexion Pharmaceuticals, Inc. is providing information regarding a previously communicated voluntary recall of two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion. … Continue reading

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Omontys peginesatide Injection by Affymax and Takeda Recall

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Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots – Serious Hypersensitivity Reactions AUDIENCE: Patients, Healthcare Professionals, Hematology ISSUE: Affymax, Inc. and Takeda Pharmaceutical Company Limited along with the U.S. Food and Drug Administration (FDA) are informing the … Continue reading

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Argatroban Injection 50 mg 50 mL 1 mg mL Recall

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Argatroban Injection 50 mg/50 mL (1 mg/mL): Recall – Potential for Visible Particulates AUDIENCE: Pharmacy, Hematology ISSUE: Eagle Pharmaceuticals Inc., supplier to The Medicines Company, issued a voluntary recall of all four (4) lots of Argatroban Injection, 50 mg per 50 mL … Continue reading

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Adcetris (brentuximab vedotin) Drug Safety Communication

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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

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Posted in FDA 2011, FDA Label Change, FDA Notice, FDA Warning, Hematology, Neurology, Oncology | Tagged , , , , , , , , , | Comments Off on Adcetris (brentuximab vedotin) Drug Safety Communication

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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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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