Archive for February, 2006
Recalls and Safety Alerts: New Information on Paxil and Congenital Malformations
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsNew warnings have been added to the labeling for Paxil and generic paroxetine based on preliminary analyses of two recent unpublished epidemiologic studies. Both studies showed a relatively small increased risk for cardiac defects in infants born to…
Recalls and Safety Alerts: Recall of Vitros Confirmatory Test for Hepatitis B
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsOrtho Clinical Diagnostics has recalled certain lots of the company's Vitros HBsAg Confirmatory Kit. This kit is used to confirm the presence of the antigen after a positive test with the Vitros HBsAg Reagent pack. Because of a problem with a diluti…
Recalls and Safety Alerts: Suspended Marketing of NeutroSpec
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsMallinckrodt and Palatin Technologies have withdrawn from the market the imaging agent NeutroSpec because of serious safety concerns. NeutroSpec is used in nuclear medicine to help diagnose patients with equivocal signs and symptoms of appendicitis….
Recalls and Safety Alerts: Avandia and Diabetic Macular Edema
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsGlaxo SmithKline has notified health professionals about reports of diabetic macular edema in patients receiving Avandia (rosiglitazone maleate) which is used to treat type 2 diabetes. These reports involved both new cases of macular edema and worsen…
Recalls and Safety Alerts: Potentially Hazardous Interaction between Avinza and Alcohol
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsLigand Pharmaceuticals has notified healthcare professionals about revised labeling for Avinza morphine sulfate extended-release capsules. These changes highlight warnings that patients should not consume alcohol while taking the drug.
These wa…
Preventing Medical Errors: Drug Name Confusion: Amicar and Omacor
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsThe Institute for Safe Medication Practices recently reported on mix-ups occuring between two drugs whose names sound and look alike: Amicar (aminocaproic acid) and Omacor. Amicar, an antifibrinolytic agent available for many years, is used to enhan…
Patients Are Asking: New Labeling for Food Allergens
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsPatients are now going to have more information about whether packaged foods contain ingredients to which they are allergic. Effective January 1, 2006, FDA is requiring food labels to state clearly whether the product includes ingredients that conta…
New Medical Products: Tamiflu Approved for Flu Prevention in Children Under 12
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsFDA recently approved the use of Tamiflu for preventing influenza in children 1 to 12 years old. Tamiflu was already approved as a preventive agent in patients 13 and older, and it is approved for treating the flu in patients older than 1 year.
…
New Medical Products: FDA Approves First Immune Globulin for Subcutaneous Use
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsFDA recently approved a new immune globulin product that is injected subcutaneously. The product, called Vivaglobin, is made by the German company ZLB Behring. Until now, immune globulin products have been administered either intravenously or intra…
Recalls and Safety Alerts: New Information on Paxil and Congenital Malformations
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsNew warnings have been added to the labeling for Paxil and generic paroxetine based on preliminary analyses of two recent unpublished epidemiologic studies. Both studies showed a relatively small increased risk for cardiac defects in infants born to…
Recalls and Safety Alerts: Recall of Vitros Confirmatory Test for Hepatitis B
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsOrtho Clinical Diagnostics has recalled certain lots of the company's Vitros HBsAg Confirmatory Kit. This kit is used to confirm the presence of the antigen after a positive test with the Vitros HBsAg Reagent pack. Because of a problem with a diluti…
Recalls and Safety Alerts: Suspended Marketing of NeutroSpec
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsMallinckrodt and Palatin Technologies have withdrawn from the market the imaging agent NeutroSpec because of serious safety concerns. NeutroSpec is used in nuclear medicine to help diagnose patients with equivocal signs and symptoms of appendicitis….
Recalls and Safety Alerts: Avandia and Diabetic Macular Edema
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsGlaxo SmithKline has notified health professionals about reports of diabetic macular edema in patients receiving Avandia (rosiglitazone maleate) which is used to treat type 2 diabetes. These reports involved both new cases of macular edema and worsen…
Recalls and Safety Alerts: Potentially Hazardous Interaction between Avinza and Alcohol
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsLigand Pharmaceuticals has notified healthcare professionals about revised labeling for Avinza morphine sulfate extended-release capsules. These changes highlight warnings that patients should not consume alcohol while taking the drug.
These wa…
Preventing Medical Errors: Drug Name Confusion: Amicar and Omacor
Closed Published by Food and Drug Adminstration (FDA): Patient Safety February 28th, 2006 in Patient Safety, Regulatory AffairsThe Institute for Safe Medication Practices recently reported on mix-ups occuring between two drugs whose names sound and look alike: Amicar (aminocaproic acid) and Omacor. Amicar, an antifibrinolytic agent available for many years, is used to enhan…
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