March 21, 2009Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use
Sharing of insulin pens may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Acyclovir Injection See Related Information section for updated information Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg) See Related Information section Source: www.fda.gov FDA Approved First DNA Test for Two Types of Human Papillomavirus The test, called Cervista HPV 16/18, detects the DNA sequences for HPV type 16 and HPV type 18 in cervical cells. Differentiating these HPV types gives health care professionals more information on a patient's risk of subsequently developing cervical cancer. Source: www.fda.gov March 20, 2009Guidance for Industry Guidance for Industry
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6: Uniformity of Dosage Units General Chapter Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 No further supply issues are anticipated. See related information section for more information Source: www.fda.gov PQRI Workshop PQRI Workshop: Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products, March 9-10, 2009, Hyatt Regency Bethesda, Bethesda, MD. Program and registration Source: www.pqri.org _ Drug Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers Drug Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers
The transition from albuterol CFC MDIs to albuterol HFA MDIs is now complete and supplies of albuterol HFA and levalbuterol HFA MDIs continue to meet total market demand. Source: www.fda.gov Warning on Potentially Contaminated Cheese Consumers should not eat certain cheese products distributed by Peregrina Cheese Corporation. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) Mallinckrodt continues to work diligently to meet the market need during this temporary period of limited supply. Xanodyne has additional releases starting February 20th, 2009. Vintage Pharmaceuticals will be releasing additional product starting February 11th, 2009. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; MVI Adult Injectable No further supply issues are anticipated Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules See Web site for additional information Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection See Web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages; Leucovorin See web site for additional information Source: www.fda.gov March 19, 2009December 2008 Safety Labeling Changes December 2008 Safety Labeling Changes
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. Source: www.fda.gov Preventing Medical Errors: Preventing Dosing Errors with Alteplase In a recent report, the Institute for Safe Medication Practices warned about the possibility of prescribing and administering the wrong dose of alteplase when the indication for the drug is not specified. ISMP described a case of a patient in an i... Source: www.accessdata.fda.gov Patients Are Asking: Potentially Fatal Salmonella Infections from Pet Turtles Turtles may look like cute pets, but it is estimated that they are responsible for over 70,000 cases of Salmonella infections every year in this country. Some of these infections can be serious or even fatal. In one case, a four week-old infant d... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Limitations of Skin Patch Testing for Diagnosing Hypersensitivity Reactions with Abacavir FDA is cautioning healthcare professionals against using skin patch testing to immunologically confirm suspected cases of hypersensitivity reaction in patients treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziag... Source: www.accessdata.fda.gov Drug Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers Drug Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers
The transition from albuterol CFC MDIs to albuterol HFA MDIs is now complete and supplies of albuterol HFA and levalbuterol HFA MDIs continue to meet total market demand. Source: www.fda.gov March 18, 2009FDA Takes Action Against KV Pharmaceutical Company FDA Takes Action Against KV Pharmaceutical Company
The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA's current Good Manufacturing Practice (cGMP) and new drug approval requirements for five years. Source: www.fda.gov FDA Warns Consumers About Potentially Contaminated Cheese The U.S. Food and Drug Administration is warning consumers not to eat Queso Fresco Fresh Cheese Mexican style soft cheese (two specific lots) or any Queso Cotija Molido Mexican style grated cheese manufactured and distributed by Peregrina Cheese Corp. of New York City. These products could be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in pregnant women, young children, frail or elderly people, and others with weakened immune systems. Source: www.fda.gov Manual of Policies and Procedures Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov FDA Approves Cardiac Adhesion Barrier for Pediatric Use Repel-CV is a synthetic film barrier inserted over the heart just before a surgeon closes the chest following an open-heart procedure. During the early healing stages, the temporary, absorbable barrier helps reduce the severity of post-surgical adhesions. Source: www.fda.gov FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) Mallinckrodt continues to work diligently to meet the market need during this temporary period of limited supply. Xanodyne has additional releases starting February 20th, 2009. Vintage Pharmaceuticals will be releasing additional product starting February 11th, 2009. Source: www.fda.gov FDA Issues Guidance for Food Manufacturers on Use of Peanut-Derived Product The U.S. Food and Drug Administration recommends that manufacturers obtain any peanut-derived ingredient only from suppliers who use production processes that have been demonstrated to adequately reduce the presence of Salmonella species (Salmonella spp.), or that they ensure that their own manufacturing process would adequately reduce the presence of Salmonella species. Source: www.fda.gov FDA issues Updated Safety Information about Raptiva (efalizumab). FDA issues Updated Safety Information about Raptiva (efalizumab).
FDA issues Updated Safety Information about Raptiva (efalizumab). Source: www.fda.gov PDUFA Report Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan (Final) Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Meeting/Forum Drug Information Association (DIA): Cardiovascular Safety, QT, and Arrhythmia Assessment in Drug Development, April 29-May 1, 2009, Hyatt Regency Besthesda, Bethesda, MD. Meeting information Source: www.diahome.org Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7: Dissolution Test General Chapter Source: www.fda.gov Standard Costs for Components of the Process for the Review of Human Drug Applications Standard Costs for Components of the Process for the Review of Human Drug Applications Source: www.fda.gov FDA and Eight Academic and Research Institutions to Collaborate Under Nanotechnology Initiative The U.S. Food and Drug Administration today unveiled a new collaboration initiative with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology. Source: www.fda.gov FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. Source: www.fda.gov Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov March 17, 2009FDA Launches SAFEKIDS Initiative with Academic and Clinical Partners FDA Launches SAFEKIDS Initiative with Academic and Clinical Partners
The Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Initiative is a multi-year project designed to address major gaps in scientific information about the safe use of anesthetics and sedatives received by millions of children each year. Source: www.fda.gov FDA Shuts Down a Flour Tortilla Manufacturer for Repeated Violations FDA Shuts Down a Flour Tortilla Manufacturer for Repeated Violations
The U.S. Food and Drug Administration (FDA) today announced that Del Rey Tortilleria Inc., Chicago, Ill., its president, and two general managers have entered into a consent decree of permanent injunction that prevents Del Rey Tortilleria from manufacturing and distributing soft-shell flour tortillas until the company obtains FDA approval. Source: www.fda.gov Preventing Medical Errors: Preventing Dosing Errors with Alteplase In a recent report, the Institute for Safe Medication Practices warned about the possibility of prescribing and administering the wrong dose of alteplase when the indication for the drug is not specified. ISMP described a case of a patient in an i... Source: www.accessdata.fda.gov Patients Are Asking: Potentially Fatal Salmonella Infections from Pet Turtles Turtles may look like cute pets, but it is estimated that they are responsible for over 70,000 cases of Salmonella infections every year in this country. Some of these infections can be serious or even fatal. In one case, a four week-old infant d... Source: www.accessdata.fda.gov FDA and Eight Academic and Research Institutions to Collaborate Under Nanotechnology Initiative The U.S. Food and Drug Administration today unveiled a new collaboration initiative with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology. Source: www.fda.gov FDA Warns Consumers About Potentially Contaminated Cheese The U.S. Food and Drug Administration is warning consumers not to eat Queso Fresco Fresh Cheese Mexican style soft cheese (two specific lots) or any Queso Cotija Molido Mexican style grated cheese manufactured and distributed by Peregrina Cheese Corp. of New York City. These products could be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in pregnant women, young children, frail or elderly people, and others with weakened immune systems. Source: www.fda.gov FDA Launches SAFEKIDS Initiative with Academic and Clinical Partners The Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Initiative is a multi-year project designed to address major gaps in scientific information about the safe use of anesthetics and sedatives received by millions of children each year. Source: www.fda.gov Recalls and Safety Alerts: Higher Mortality for Certain Elderly Patients with Innohep Celgene is alerting healthcare professionals of an increased mortality risk among certain elderly patients treated with Innohep (tinzaparin sodium injection). Innohep is a low-molecular weight heparin that is used along with warfarin to treat acute ... Source: www.accessdata.fda.gov March 16, 2009FDA Approves Cardiac Adhesion Barrier for Pediatric Use FDA Approves Cardiac Adhesion Barrier for Pediatric Use
Repel-CV is a synthetic film barrier inserted over the heart just before a surgeon closes the chest following an open-heart procedure. During the early healing stages, the temporary, absorbable barrier helps reduce the severity of post-surgical adhesions. Source: www.fda.gov Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6: Uniformity of Dosage Units General Chapter Source: www.fda.gov Raptiva (efalizumab) Raptiva (efalizumab)
Public Health Advisory describes rare brain condition, progressive multifocal leukoencephalopathy, associated with the use of Raptiva. Source: www.fda.gov FDA Approves Cardiac Adhesion Barrier for Pediatric Use Repel-CV is a synthetic film barrier inserted over the heart just before a surgeon closes the chest following an open-heart procedure. During the early healing stages, the temporary, absorbable barrier helps reduce the severity of post-surgical adhesions. Source: www.fda.gov FDA Takes Action Against KV Pharmaceutical Company The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA's current Good Manufacturing Practice (cGMP) and new drug approval requirements for five years. Source: www.fda.gov March 2009 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Source: www.fda.gov FDA Approved First DNA Test for Two Types of Human Papillomavirus The test, called Cervista HPV 16/18, detects the DNA sequences for HPV type 16 and HPV type 18 in cervical cells. Differentiating these HPV types gives health care professionals more information on a patient's risk of subsequently developing cervical cancer. Source: www.fda.gov FDA Warns Consumers About Potentially Contaminated Cheese The U.S. Food and Drug Administration is warning consumers not to eat Queso Fresco Fresh Cheese Mexican style soft cheese (two specific lots) or any Queso Cotija Molido Mexican style grated cheese manufactured and distributed by Peregrina Cheese Corp. of New York City. These products could be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in pregnant women, young children, frail or elderly people, and others with weakened immune systems. Source: www.fda.gov Zonisamide (marketed as Zonegran, and generics) Treatment with zonisamide can cause metabolic acidosis in some patients. Source: www.fda.gov FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 23, 2009 FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 23, 2009
FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 23, 2009 Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) - (updated) Increase in demand related to product recalls by other manufacturers Source: www.fda.gov FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs Source: www.fda.gov March 15, 2009Recalls and Safety Alerts: Serious Skin Reactions in Asian Patients on Phenytoin and Fosphenytoin Recalls and Safety Alerts: Serious Skin Reactions in Asian Patients on Phenytoin and Fosphenytoin
FDA is investigating new preliminary data suggesting an increased risk of serious skin reactions from the anti-epileptic drugs phenytoin and fosphenytoin if they are taken by Asian patients who are positive for the human leukocyte antigen allele HLA-... Source: www.accessdata.fda.gov Raptiva (efalizumab) Public Health Advisory describes rare brain condition, progressive multifocal leukoencephalopathy, associated with the use of Raptiva. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Levoleucovorin (Fusilev) 50 mg single use vials See Web site for additional information Source: www.fda.gov Zonisamide (marketed as Zonegran, and generics) Treatment with zonisamide can cause metabolic acidosis in some patients. Source: www.fda.gov Recalls and Safety Alerts: Higher Mortality for Certain Elderly Patients with Innohep Celgene is alerting healthcare professionals of an increased mortality risk among certain elderly patients treated with Innohep (tinzaparin sodium injection). Innohep is a low-molecular weight heparin that is used along with warfarin to treat acute ... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Limitations of Skin Patch Testing for Diagnosing Hypersensitivity Reactions with Abacavir FDA is cautioning healthcare professionals against using skin patch testing to immunologically confirm suspected cases of hypersensitivity reaction in patients treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziag... Source: www.accessdata.fda.gov Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. Source: www.fda.gov January 2009 Safety Labeling Changes Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets See Related information section for updated letter Source: www.fda.gov Preventing Medical Errors: Preventing Dosing Errors with Alteplase In a recent report, the Institute for Safe Medication Practices warned about the possibility of prescribing and administering the wrong dose of alteplase when the indication for the drug is not specified. ISMP described a case of a patient in an i... Source: www.accessdata.fda.gov |
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