Category Archives: Gastroenterology

Incretin Mimetic Drugs for Type 2 Diabetes

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Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication – Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas    AUDIENCE: Gastroenterology, Endocrinology, Oncology, Patient ISSUE: FDA is evaluating unpublished new findings by a group of … Continue reading

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Posted in Endocrinology, FDA 2013, FDA Warning, Gastroenterology, Oncology, Patients | Tagged , , , , , , , , | Comments Off on Incretin Mimetic Drugs for Type 2 Diabetes

Samsca tolvaptan Drug Warning

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Samsca (tolvaptan): Drug Warning – Potential Risk of Liver Injury AUDIENCE: Gastroenterology, Nephrology, Pharmacy ISSUE: Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial in about 1400 … Continue reading

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Posted in FDA 2013, FDA Warning, Gastroenterology, Nephrology, Pharmacy | Tagged , , , , , , , , , , | Comments Off on Samsca tolvaptan Drug Warning

Incivek telaprevir Drug Safety Communication

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Incivek (telaprevir) In Combination with Drugs Peginterferon Alfa and Ribavirin (Incivek Combination Treatment): Drug Safety Communication – Serious Skin Reactions   AUDIENCE: Internal Medicine, Gastroenterology, Dermatology ISSUE: FDA received reports of serious skin reactions, some fatal, in patients taking the … Continue reading

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Posted in Dermatology, FDA Label Change, FDA Safety Communication, Gastroenterology, Internal Medicine | Tagged , , , , , , , , , | Comments Off on Incivek telaprevir Drug Safety Communication

Ondansetron Zofran IV Drug Safety Communication QT prolongation

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Ondansetron (Zofran) IV: Drug Safety Communication – QT prolongation AUDIENCE: Oncology, Surgery, Gastroenterology ISSUE: The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a … Continue reading

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Posted in FDA 2012, FDA Safety Communication, Gastroenterology, Oncology, Surgery | Tagged , , , , , , , , , | Comments Off on Ondansetron Zofran IV Drug Safety Communication QT prolongation

Proton Pump Inhibitors PPIs Drug Safety Communication

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Proton Pump Inhibitors (PPIs) – Drug Safety Communication: Clostridum Difficile-Associated Diarrhea (CDAD) Can be Associated With Stomach Acid Drugs AcipHex (rabeprazole sodium) Dexilant (dexlansoprazole) Nexium (esomeprazole magnesium)  Omeprazole (omeprazole) Over-the-Counter (OTC) Prevacid (lansoprazole) and OTC Prevacid 24hr Prilosec (omeprazole)  and … Continue reading

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Posted in Consumer Products, Family Practice, FDA 2012, FDA Notice, FDA Safety Communication, FDA Warning, Gastroenterology | Tagged , , , , , , , , , , , , , , , , , | Comments Off on Proton Pump Inhibitors PPIs Drug Safety Communication

Tysabri (natalizumab) Drug Safety Communication

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Tysabri (natalizumab): Drug Safety Communication – New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML) AUDIENCE: Neurology, Gastroenterology ISSUE: FDA notified healthcare profesisonals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal … Continue reading

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Posted in FDA 2012, FDA Notice, Gastroenterology, Neurology | Tagged , , , , , , , , | Comments Off on Tysabri (natalizumab) Drug Safety Communication

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 on Tumor Necrosis Factor-alpha (TNFα) Blockers Label Change