Category Archives: FDA Notice

Main Street Family Pharmacy Tennessee FDA Alerts

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Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections – Update [UPDATE 06/07/2013] FDA has identified bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate … Continue reading

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Posted in FDA Notice, FDA Recall, Healthcare Professionals, Patients | Tagged , , , , , , , , , | Comments Off

Pradaxa dabigatran etexilate mesylate Drug Safety Communication

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Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves AUDIENCE: Cardiology, Patient ISSUE: The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the … Continue reading

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Posted in Cardiology, FDA 2012, FDA Notice, FDA Warning, Patients | Tagged , , , | Comments Off

St Jude Medical Riata Implantable Cardioverter Defibrillator ICD Leads

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  St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication – Premature Insulation Failure [Posted 08/16/2012]   AUDIENCE: Cardiology, Radiology, Surgery, Family Practice ISSUE: The Food and Drug Administration (FDA) is providing information and recommendations regarding safety concerns with the … Continue reading

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Posted in Cardiology, Family Practice, FDA 2012, FDA Notice, Radiology, Surgery | Tagged , , , , , , , , , , | Comments Off

Zithromax azithromycin FDA Drug Risks

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Zithromax (azithromycin): FDA Statement on risk of cardiovascular death Read the MedWatch safety alert, including a link to the Drug Safety Communication at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304503.htm Audience: Primary Care, Pharmacy ISSUE: FDA notified healthcare professionals that it is aware of the study … Continue reading

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Posted in Cardiology, FDA 2012, FDA Notice, Pharmacy | Tagged , , , | Comments Off

Victrelis and Ritonavir Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs Drug Safety Communication

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Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication – Drug Interactions AUDIENCE: Infectious Disease, Pharmacy ISSUE: FDA notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis … Continue reading

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Posted in FDA 2012, FDA Notice, FDA Safety Communication, Infectious Disease, Pharmacy | Tagged , , , , , , , | Comments Off

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

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

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

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

Gilenya (fingolimod) Drug Safety Communication

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Gilenya (fingolimod): Drug Safety Communication – Safety Review of a Reported Death After the First Dose AUDIENCE: Neurology, Patients ISSUE: The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking … Continue reading

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Posted in FDA 2011, FDA Notice, multiple sclerosis (MS), Neurology | Tagged , , , , , | Comments Off