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Category Archives: Gastroenterology
Incretin Mimetic Drugs for Type 2 Diabetes
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Findings of the Pancreas AUDIENCE: Gastroenterology, Endocrinology, Oncology, Patient ISSUE: FDA is evaluating unpublished new findings by a group of … Continue reading
Posted in Endocrinology, FDA 2013, FDA Warning, Gastroenterology, Oncology, Patients
Tagged drug risks, Endocrinology, FDA warning, Gastroenterology, Incretin Mimetic Drugs, Incretin Mimetic Drugs for Type 2 Diabetes, Oncology, Patient, Type 2 Diabetes
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Samsca tolvaptan Drug Warning
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
Posted in FDA 2013, FDA Warning, Gastroenterology, Nephrology, Pharmacy
Tagged drug risks, Drug Warning, FDA notice, FDA warning, Gastroenterology, Nephrology, Pharmacy, Risk of Liver Injury, Samsca, Samsca tolvaptan Drug Warning, tolvaptan
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Incivek telaprevir Drug Safety Communication
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
Posted in Dermatology, FDA Label Change, FDA Safety Communication, Gastroenterology, Internal Medicine
Tagged Dermatology, Drug Safety Communication, Gastroenterology, Incivek, Incivek telaprevir Drug Safety Communication, Internal Medicine, Peginterferon Alfa, Ribavirin, Serious Skin Reactions, telaprevir
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Ondansetron Zofran IV Drug Safety Communication QT prolongation
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
Posted in FDA 2012, FDA Safety Communication, Gastroenterology, Oncology, Surgery
Tagged drug risks, Drug Safety Communication, FDA Drug Safety Communication, FDA notice, Gastroenterology, Oncology, Ondansetron Zofran IV, Ondansetron Zofran IV Drug Safety Communication QT prolongation, QT prolongation, Surgery
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Proton Pump Inhibitors PPIs Drug Safety Communication
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
Posted in Consumer Products, Family Practice, FDA 2012, FDA Notice, FDA Safety Communication, FDA Warning, Gastroenterology
Tagged Aciphex, Dexilant, drug risks, Drug Safety Communication, FDA notice, FDA Safety Communication, FDA warning, Nexium, Omeprazole, Prevacid, Prilosec, Proton Pump Inhibitors PPIs, Proton Pump Inhibitors PPIs Drug Safety Communication, PRotonix, safety label changes, stomach acid reducers, Vimovo, Zegerid
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Tysabri (natalizumab) Drug Safety Communication
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
Tumor Necrosis Factor-alpha (TNFα) Blockers Label Change
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
Posted in FDA 2011, FDA Label Change, Gastroenterology, Oncology, Rheumatology
Tagged Cimzia (certolizumab pegol), Enbrel (etanercept), Gastroenterology, Humira (adalimumab), Oncology, Remicade (infliximab), Rheumatology, Simponi (golimumab)
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