Category Archives: FDA 2011

The Biggest Drug Recalls of 2011

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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

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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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December 2011 Safety Labeling Change

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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

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Bedford Laboratories Polymyxin B Vecuronium Bromide Recall

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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

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Endo Pharmaceuticals Opiate Products by Novartis Consumer Health

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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

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Novartis Exedrin Bufferin Gas-X Prevention NoDoz Recall

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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

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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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Eclectic Institute Dietary Supplements Goto Kola Bladderwrack Recall

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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

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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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Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants Drug Safety Communication

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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

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