The Medical Letter Online

What's New: Drugs

Comunicado de la FDA sobre la seguridad de los medicamentos: Sucesos adversos graves resultantes de ingestión accidental por niños de colirios (gotas para los ojos) y aerosoles nasales de venta libre

El 25 de octubre del 2012 La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) le advirtió al público que si los niños ingieren accidentalmente (tragan) colirios o gotas para los ojos utilizados para aliviar el enrojecimiento de estos o descongestionantes nasales en aerosol de venta libre (disponibles sin [...]

Update on Fungal Meningitis

Update on Fungal Meningitis What’s New: Drugs RSS Feed

Update on Fungal Meningitis

Update on Fungal Meningitis What’s New: Drugs RSS Feed

Drug Establishments Current Registration Site

Drug Establishments Current Registration Download File last updated October 17, 2012 What’s New: Drugs RSS Feed

FDA Drug Info Rounds

Single-Ingredient Oral Colchicine Video

FDA Drug Info Rounds pharmacists discuss the differences between approved and unapproved colchicine products, concerns regarding unapproved single-ingredient oral colchicine, and how patients can offset the increased cost of Colcrys. FDA Drug Info Rounds

Long-Acting Beta-Agonists (LABAs) Video

Long-Acting Beta-Agonists (LABAs), a class of medications used for the treatment of asthma and chronic obstructive pulmonary disease (COPD), now have new recommendations in their drug label intended to promote their safe use in the treatment of asthma. FDA Drug Info Rounds

Proton Pump Inhibitors (PPIs) Video

FDA Drug Info Rounds pharmacists discuss new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors, strengths and limitations of the studies, and recommendations for pharmacists. FDA Drug Info Rounds

Evamist Video

FDA Drug Info Rounds pharmacists discuss FDA’s ongoing safety review of adverse event reports in children who may have been unintentionally exposed to the drug through skin contact with women using Evamist. FDA Drug Info Rounds

FDA Drug Shortages

Drug Shortages

Resolved Drug Shortages: Digoxin Injection FDA Drug Shortages

Drug Shortages

Resolved Drug Shortages: Pantoprazole (Protonix) Injection  FDA Drug Shortages

Drug Shortages

Drugs to be Discontinued: Gastromark FDA Drug Shortages

Drug Shortages

Resolved Drug Shortages: Sodium Lactate Injection FDA Drug Shortages

MedWatch Safety Alerts

Classic Zi Xiu Tang Bee Pollen Capsules And Ultimate Formula Capsules by Zi Xiu Tang Success: Recall – Undeclared Sibutramine

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. MedWatch Safety Alert RSS Feed

Ameridose, LLC: Recall of Unexpired Products in Circulation

FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. MedWatch Safety Alert RSS Feed

Hospira Symbiq Infusion System Touchscreen: Class 1 Recall – May Not Respond to Selection

Failure of touchscreen to respond to user input could result in a delay or interruption in therapy or over delivery or under delivery of medication. MedWatch Safety Alert RSS Feed

Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall – User Difficulty With Firing Stapler Devices

Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal. MedWatch Safety Alert RSS Feed

Recalls

Ameridose Issues Recall of All Products

Ameridose today announced it will commence a voluntary recall of any unexpired products remaining in circulation. This action is voluntary, and represents an expansion of our cooperation with the U.S.Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy. Food and Drug Administration–Recalls/Safety Alerts

Wegmans Recalls Gluten Free Baking Products – Chocolate Cake Mix, Food You Feel Good About Gluten Free Honey Cornbread Mix, and Food You Feel Good About All Purpose Baking Mix Because Products May Contain Undeclared Soy

Wegmans Food Markets, Inc. is voluntarily recalling all code dates of Wegmans Gluten Free Baking Products Food and Drug Administration–Recalls/Safety Alerts

BT McElrath Chocolatier, Inc. Announces Nationwide Recall Of Peanut Butter Pave Due To Possible Health Risks

: October 26th 2012 BT McElrath Chocolatier, Inc. is initiating a voluntary recall of the seasonal peanut butter pave because they have the potential to be contaminated with Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Food [...]

Hospira Issues A Voluntary Nationwide Recall Of Symbiq Infusion Systems Due To Inaccurate Response Of The Touch Screen To User Selection/Input

Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary nationwide Class I recall of Symbiq™ infusion systems (list number 16026 Symbiq™ One-Channel Infuser and list number 16027 Symbiq™ Two-Channel Infuser, all serial numbers). This action is due to infusion pump LCD touch screens that may not respond to user selection, resulting in users [...]

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Latest Medication News

| January 17, 2012 | 0 Comments

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Test Your Home for Radon During Lung Cancer Awareness Month

| November 2, 2012 | 0 Comments

Recent research by Health Canada estimates that 16 per cent of lung cancer deaths among Canadians are attributable to indoor radon exposure, making radon gas the second leading cause of lung cancer after tobacco smoking. Health Canada RSS – Media Room

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News and press releases: European Medicines Agency website unavailable intermittently Saturday 6 October

| November 1, 2012 | 0 Comments

The European Medicines Agency’s website, ema.europa.eu, will be unavailable intermittently between 8.00am and 6.00pm on Saturday 6 October 2012, due to a test of the Agency’s disaster recovery plan. Patient safety, news and press releases: human and vet

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Metabolic disorders: Safe cannabinoid receptor modulators in sight?

| November 1, 2012 | 0 Comments

Metabolic disorders: Safe cannabinoid receptor modulators in sight? Nature Reviews Drug Discovery 11, 749 (2012). doi:10.1038/nrd3851 Author: Sarah Crunkhorn The endocannabinoid system is involved in the regulation of appetite and is overactive in obesity. Although pharmacological blockade of cannabinoid receptor 1 (CB1R) has emerged as an effective anti-obesity strategy, the risk of adverse neuropsychiatric effects [...]

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Carboplatin injection (600mg/60mL) – Visible Particles in One Lot

| November 1, 2012 | 0 Comments

A recall has been initiated for one lot of Carboplatin injection distributed in Canada due to visible crystal like particulate matter observed during an inspection of retained samples. Vials of the affected lot should not be used and should be returned to Hospira. Health Canada RSS – MedEffect Canada – Advisories and Recalls for Health [...]

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Voluntary Suspension of Flu Vaccines (Agriflu and Fluad) Lifted

| November 1, 2012 | 0 Comments

Health Canada has completed its review of safety information for Agriflu and Fluad and is releasing the two seasonal flu vaccines for immediate use. Health Canada RSS – Media Room

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Call for scientific data for the systematic review of the monograph on Mentha x piperita L., aetheroleum, draft: consultation open

| November 1, 2012 | 0 Comments

The HMPC invites all interested parties such as pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients’ associations, governmental institutions as well as EU and EEA-EFTA Member States to submit any scientific data that the HMPC should consider at the 5-year review of the monograph on Mentha x piperita L., aetheroleum towards [...]

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GABLOFEN (Baclofen) Injection [CNS Therapeutics, Inc.]

| October 31, 2012 | 0 Comments

Updated Date: Oct 24, 2012 EST DailyMed Drug Label Updates for the last seven days (since Oct 24, 2012 EST)

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Summary Basis of Decision (SBD) for TRETTEN

| October 31, 2012 | 0 Comments

Health Canada Summary Basis of Decision October 19, 2012, Tretten, catridecacog, 15 mg/vial, lyophilized powder, Novo Nordisk Canada Inc., Submission Control No. 152228 Health Canada RSS – Drug Products, Drugs and Health Products

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Call for scientific data for use in HMPC assessment work on Cetraria islandica (L.) Acharius s.l. , draft: consultation open

| October 31, 2012 | 0 Comments

The HMPC invites all interested parties such as pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients’ associations, governmental institutions as well as EU and EEA-EFTA Member States to submit any scientific data, which may be used in the assessment of Cetraria islandica (L.) Acharius s.l. as part of the establishment of [...]

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DAPTACEL (Corynebacterium Diphtheriae Toxoid Antigen (Formaldehyde Inactivated), Clostridium Tetani Toxoid Antigen (Formaldehyde Inactivated), Bordetella Pertussis Toxoid Antigen (Glutaraldehyde Inactivated), Bordetella Pertussis Filamentous Hemagglutinin Antigen (Formaldehyde Inactivated), Bordetella Pertussis Pertactin Antigen, And Bordetella Pertussis Fimbriae 2/3 Antigen) Injection, Suspension [Sanofi Pasteur Inc.]

| October 30, 2012 | 0 Comments

Updated Date: Oct 23, 2012 EST DailyMed Drug Label Updates for the last seven days (since Oct 23, 2012 EST)

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