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Category Archives: FDA 2011
The Biggest Drug Recalls of 2011
The Biggest Drug Recalls of 2011 Always be careful when you take your medications. Make sure you talk about it with your doctor or make some research because some of them may worsen the condition or risk your health instead … Continue reading
Posted in FDA 2011, FDA Recall
Tagged 2011, Class 1 Recall, drug recalls, drug risks, FDA notice, FDA recall, FDA warning, Recall
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Adcetris (brentuximab vedotin) Drug Safety Communication
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
Posted in FDA 2011, FDA Label Change, FDA Notice, FDA Warning, Hematology, Neurology, Oncology
Tagged Adcetris, Adcetris (brentuximab vedotin) Drug Safety Communication, brentuximab vedotin, drug risks, Drug Safety Communication, FDA notice, FDA warning, Progressive Multifocal Leukoencephalopathy, Pulmonary Toxicity, safety label changes
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December 2011 Safety Labeling Change
The MedWatch December 2011 Safety Labeling Changes posting includes 40 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names and … Continue reading
Posted in FDA 2011, FDA Label Change, FDA Warning
Tagged Capoten, Danocrine, December 2011, December 2011 Safety Labeling Change, Desferal, Dilantin-125, drugs, Edarbi, Eloxatin, fda, Heparin, Isentress, Keppra, labeling change, Multaq tablets, Norvir, notice, Onglyza, Ovide, PegIntron, Plavix, Relenza, Remeron, safety, Tyzeka, warnings, Zegerid
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Bedford Laboratories Polymyxin B Vecuronium Bromide Recall
Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall – Glass Particles AUDIENCE: Pharmacy, Risk Manager ISSUE: Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were … Continue reading
Endo Pharmaceuticals Opiate Products by Novartis Consumer Health
Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory – Potential Safety Risk Including the following products: Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII Opana (oxymorphone hydrochloride) CII Oxymorphone hydrochloride Tablets CII PERCOCET (oxycodone hydrochloride and acetaminophen USP) … Continue reading
Posted in Consumer Products, FDA 2011, FDA Warning, Pharmacy
Tagged drug risks, Endo Pharmaceuticals .Opiate Products. Novartis Consumer Health, Endo Pharmaceuticals Opiate Products by Novartis Consumer Health, ENDOCET, ENDODAN, FDA notice, FDA warning, MORPHINE SULFATE, Opana, Opana ER, Oxymorphone, PERCOCET, PERCODAN, ZYDONE
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Novartis Exedrin Bufferin Gas-X Prevention NoDoz Recall
Novartis Consumer Health Over-The-Counter Products: Recall – Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps including Excedrin, NoDoz, Bufferin, Gas-X Prevention AUDIENCE: Consumer, Pharmacy ISSUE: Novartis Consumer Health Inc. is voluntarily recalling all lots of over-the-counter … Continue reading
Posted in Consumer Products, FDA 2011, FDA Recall, Pharmacy
Tagged Bufferin, drug risks, Exedrin, FDA recall, Gas-X Prevention, NoDoz, Novartis, Novartis Exedrin Bufferin Gas-X Prevention NoDoz Recall, Recall
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Over-the-Counter (OTC) Liquid acetaminophen FDA Notice
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
Posted in Consumer Products, FDA 2011, FDA Notice, Pediatrics, Pharmacy
Tagged Children Medicines, Drug Safety Communication, FDA notice, Infant/Pain Reliever, Liquid acetaminophen, Little Fevers, Over-the-Counter (OTC), Over-the-Counter (OTC) Liquid acetaminophen, Pedia Care, safety label changes, Triaminic, Triaminic Infants’ Syrup Fever Reducer Pain Reliever, Tylenol
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Eclectic Institute Dietary Supplements Goto Kola Bladderwrack Recall
Eclectic Institute Dietary Supplements: Recall – Possible Salmonella Contamination Include the products Gotu Kola (Centella Asiatica), Bladderwrack (Fucus Vesiculosus) AUDIENCE: Consumer ISSUE: Eclectic Institute is voluntarily recalling specific lots of its freeze-dried capsules containing Gotu Kola (Centella asiatica) and Bladderwrack … Continue reading
Posted in Consumer Products, FDA 2011, FDA Recall
Tagged Bladderwrack, Consumer Products, Drug Safety Communication, Eclectic Institute Dietary Supplements, FDA recall, Goto Kola, Recall
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Gilenya (fingolimod) Drug Safety Communication
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
Posted in FDA 2011, FDA Notice, multiple sclerosis (MS), Neurology
Tagged Drug Safety Communication, FDA notice, Gilenya (fingolimod), Gilenya (fingolimod) Drug Safety Communication, multiple sclerosis (MS), Neurology
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Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants Drug Safety Communication
Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication – Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn Including Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, … Continue reading
Posted in Family Practice, FDA 2011, FDA Notice, OBGYN, Psychiatry
Tagged (SSRI), Antidepressants, Celexa (citalopram), Dietary Supplements, Drug Safety Communication, Family Practice, FDA notice, Lexapro (escitalopram), Luvox, Luvox CR (fluvoxamine), OBGYN, Paxil, Paxil CR, Pexeva (paroxetine), Prozac, Psychiatry, Sarafem, Selective Serotonin Reuptake Inhibitor, Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants, Symbyax (fluoxetine), Viibryd (vilazodone), Zoloft (sertraline)
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