May 2, 2009FDA's MedWatch Safety Alerts: April 2009 FDA's MedWatch Safety Alerts: April 2009
A look at some of the recent safety alerts on medical products. Source: www.fda.gov FDA has approved pancrelipase (Creon Delayed-Release Capsules) FDA has approved pancrelipase (Creon Delayed-Release Capsules) for adult and pediatric patients with exocrine pancreatic insufficiency Source: www.fda.gov April 2009 Patient Safety News April 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 Manual of Policies and Procedures (MaPP) Productivity Documentation in the Division of Bioequivalence Source: www.fda.gov FDA issues Information for Healthcare Professionals: Ceftriaxone (marketed at Rocephin and generics) FDA issues Information for Healthcare Professionals: Ceftriaxone (marketed at Rocephin and generics) Source: www.fda.gov Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)
Strengthened warnings in product labeling and boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected. Source: www.fda.gov Raw Alfalfa Sprouts Linked To Salmonella Contamination The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) today recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts, until further notice because the product has been linked to Salmonella serotype Saintpaul contamination. Other types of sprouts have not been implicated at this time. Source: www.fda.gov FDA, FTC Warn Public of Fraudulent 2009 H1N1 Influenza Products The U.S. Food and Drug Administration and the Federal Trade Commission are alerting the public to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus. The agencies are also advising operators of offending web sites that they must take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action. Source: www.fda.gov FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs. Source: www.fda.gov May 1, 2009FDA Requires Boxed Warning for All Botulinum Toxin Products FDA Requires Boxed Warning for All Botulinum Toxin Products
Prompted by reports of serious adverse events, the U.S. Food and Drug Administration today announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Acyclovir Injection Resolved Drug Shortages: Acyclovir Injection, APP currently has all presentations available and Bedford currently reports available product for drop shipment Source: www.fda.gov Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov April 30, 2009Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection
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) Follow-up Dear Healthcare Professional Letter added to the Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated) Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml: See Related Information Section Source: www.fda.gov Drug Shortages: Current Drug Shortages; Leucovorin Please call 1-888-TevaUSA for additional information. Teva is manufacturing at full capacity. Bedford Customer Service 1-440-232-3320 Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Leucovorin Calcium Solution for Injection Resolved Drug Shortages: Leucovorin Calcium Solution for Injection, see Related Information Section Source: www.fda.gov FDA's MedWatch Safety Alerts: April 2009 A look at some of the recent safety alerts on medical products. Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Calcium Disodium Versenate Injection 200 mg/mL 5 mL ampules (NDC 00089-0510-06) Drug Shortages: Current Drug Shortages: Calcium Disodium Versenate Injection 200 mg/mL 5 mL ampules (NDC 00089-0510-06)
Additional Information: FDA and Graceway are working to resolve the shortage as soon as possible. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Acyclovir Injection See Related Information section for updated information Source: www.fda.gov FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans The U.S. Food and Drug Administration, in response to requests from the U.S. Centers for Disease Control and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test. Source: www.fda.gov FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely
The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs. Source: www.fda.gov Influend Cough and Cold Products Recall due to possibility of product being superpotent. Source: www.fda.gov Personal Care Non-Acetone Nail Polish Remover Nationwide recall issued because of the potential for the product to cause chemical burns to the fingers of users. Source: www.fda.gov Libimax Recall of dietary supplement due to undeclared drug tadalafil, which may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Source: www.fda.gov Recalls and Safety Alerts: Ethex Corp. Expands Recall of Generic Drugs and Supplements UPDATE: The FDA announced a Consent Decree of permanent injunction enjoining KV Pharmaceutical Company, its subsidiaries Ethex Corporation and Ther-Rx Corporation, and its principal officers. The injunction will prevent the companies from manufactu... Source: www.accessdata.fda.gov April 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 April 29, 2009February First-Time Generic Drug Approvals February First-Time Generic Drug Approvals
Office of Generic Drugs: February First-Time Generic Drug Approvals Source: www.fda.gov FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov FDA Approves Monthly Injectable Drug for Treating Three Types of Immune-Related Arthritis The U.S. Food and Drug Administration today approved Simponi (golimumab), a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. Source: www.fda.gov Guidance for Industry New Revised/Withdrawn List for 2009 Source: www.fda.gov Division of Drug Marketing, Advertising, and Communications issues 14 letters Division of Drug Marketing, Advertising, and Communications issues 14 letters Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection
See Web site for additional information Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Leucovorin Calcium Solution for Injection Resolved Drug Shortages: Leucovorin Calcium Solution for Injection, see Related Information Section Source: www.fda.gov Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov April 28, 2009SAMHSA and FDA Join to Educate the Public on the Safe Use of Methadone SAMHSA and FDA Join to Educate the Public on the Safe Use of Methadone
The U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Food and Drug Administration (FDA) today launched an initiative to help ensure the safe use of methadone. A prescription drug best known as a treatment for addiction and dependence on heroin and other narcotic pain medicines, methadone is also prescribed to treat moderate-to-severe chronic pain patients. The campaign responds to concerns about an escalating number of poisoning deaths linked to the improper use of this medication. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Triamcinolone Hexacetonide (Aristospan) Triamcinolone Hexacetonide (Aristospan); Manufacturing Delays Source: www.fda.gov April 27, 2009Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets
Current Drug Shortages: Metoprolol succinate extended release tablets, see updated letter in Related Information Section Source: www.fda.gov Preventing Medical Errors: Confusing Heparin Labels Can Lead to Errors Preventing Medical Errors: Confusing Heparin Labels Can Lead to Errors
The Institute for Safe Medication Practices (ISMP) points out that some multiple dose heparin vials have potentially confusing labels that could lead to dangerous overdoses. These vials, which contain 4 mL of heparin solution, are labeled "10,000 US... Source: www.accessdata.fda.gov |
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