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PROYNOM220SSA12015, OPERACIÓN DE LA FARMACOVIGILANCIA
El presente Proyecto se publica a efecto de que los interesados, dentro de los 60 días naturales siguientes a la fecha de su difusión en el Diario Oficial de la Federación, presenten sus comentarios en idioma español y con el sustento técnico correspondiente ante el Comité Consultivo Nacional de Normalizaci...Ver más
0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: Recall - Particulate Matter
ISSUE: Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) at the hospital/retail level due to the presence of particulate matter within a single vial. In the event that the particulate is administered to a patient, it may result in ...Ver más
7 de cada 10 personas que acude a la farmacia para perder peso toma plantas medicinales
El 72% de las personas que acude a la farmacia para perder peso recurre a preparados farmacéuticos de plantas medicinales, según un estudio del Centro de Investigación sobre Fitoterapia (INFITO) con 2.000 participantes de toda España, analizados por dietistas. Esto supone un incremento de 11 puntos en los últimos ...Ver más
Not to use anti-malaria drug, Lariam, due to its potential to cause severe psychological side-effect
A parliamentary committee has published a new report urging the armed forces not to use anti-malaria drug, Lariam, due to its potential to cause severe psychological side-effects.The report urges that the drug, which is manufactured by Roche, should only be used as a “drug of last resort”. The report concludes that prescribing Lariam sh...Ver más
SOS Telecom, Inc. Recalls New Unapproved Drugs Marked as Dietary Supplements
SOS Telecom, Inc. of Bayside, NY is voluntarily recalling all lots of the following products to the consumer level because these products were tested by the FDA and found to contain Sildenafil, and analogs of Sildenafil. Sildenafil is a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED), makin...Ver más
Olanzapine: Drug Safety Communication - FDA Warns About Rare But Serious Skin Reactions
ISSUE: FDA is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. FDA is adding a new warning to the drug labels for all olanzapine-containing products that describes this severe condition known as Drug Reaction with Eosinophilia and Systemic Sy...Ver más
Fresenius Kabi Issues Voluntary Nationwide Recall of Sensorcaine®-MPF
Fresenius Kabi USA announced today it is voluntarily recalling a single lot (Lot Number 6111504; Product Code 470237) of Sensorcaine®-MPF (bupivacaine HCl) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL vial. The recall is being performed to the user level due to visible particulate matter characterized as glass observed by the company...Ver más
Risk of Heart Failure: Diabetes Medications Containing Saxagliptin and Alogliptin
ISSUE: An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. As a result, FDA is adding new warnings to the drug labels about this safety issue.This Communication is an update to the 02/11/2014 FDA...Ver más
Some of the largest European drugmakers paid US doctors and teaching hospitals $1.5 billion in 2014
The fees were paid to doctors for travel and entertainment, consultancy services and promotional speeches surrounding drugs, and for facilitating clinical trials for new drugs.The figures come from a new federal-government transparency awareness drive brought in as part of President Obama's US healthcare reforms.The 2010 Affordable Care Act include...Ver más
Grexit Crisis: Pharma Firms ask EU to Prevent Drug Price Reductions - See more at: http://lsconnect.
The pharma industry is calling on the European Union (EU) to prevent price reductions spreading around Europe if Greece leaves the Euro and introduces a new, devalued, currency. With reimbursement bodies in 26 of the 28 member states of the EU referencing other European countries in medicines price negotiations, it is seen as inevitable that price ...Ver más
F.D.A. Wants Trans Fats Gone in 3 Years
The Food and Drug Administration is cracking down on trans fats in a big way — one that could save thousands of lives a year. In a new ruling, the F.D.A. has given the food industry three years to eliminate all artificial trans fats from the food supply. Although the prevalence of artificial trans fats has significantly reduced in the last de...Ver más
Notes from a Conflict-of-Interest "Myth" Instigator: Big Pharma Has Cures What Don't Ail Ya!
A study published in 2010 found significant financial gifts (up to 69 percent of overall funding) in the state of Vermont between pharmaceutical companies and specialists in psychiatry (Chimonas, et al. 2010). Although all these are covered by “disclosure laws,” which maintain that it is acceptable to have a conflict of interest in this...Ver más
DMBA in Dietary Supplements
DMBA is labeled as a dietary ingredient in some products marketed as dietary supplements. However, the FDA is not aware of any information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994. As a result, for dietary supplements that contain DMBA to be lawfully marketed, one of the foll...Ver más
Se sospecha que por vacuan mueren dos infantes
El Instituto Mexicano del Seguro Social (IMSS) informa que el día de ayer en la localidad de La Pimienta en el municipio de Simojovel, Chiapas, se aplicaron a 52 niños las vacunas de BCG (Tuberculosis), Rotavirus y Hepatitis B, como parte del Programa Nacional de Vacunación que está encaminado a disminuir la presencia de...Ver más
FDA Cracking Down on Dietary Supplement Company
The Food and Drug Administration is suing one company for allegedly failing to properly test its ingredients.Ver más
Kids hartes By detergent "pods"
CHICAGO (AP) — Accidental poisonings from squishy laundry detergent packets sometimes mistaken for toys or candy landed more than 700 U.S. children in the hospital in just two years, researchers report. Coma and seizures were among the most serious complications. The cases stem from the more than 17,000 poison center calls about the products ...Ver más
Comunicado COFEPRIS
Comunicado de COFEPRIS http://www.cofepris.gob.mx/AZ/Documents/Farmacovigilancia/Ciproterona%20Etinilestradiol.pdfVer más
Recall de paquetes de cirugía
Sterile Convenience Surgical Packs by Customed, Inc.: Recall - Potential Loss of SterilityISSUE: Customed, Inc. initiated a recall of sterile convenience surgical packs. The products have been found to have a potential defect due to adhesion. The defect could result in loss of product sterility and lead to infection. No serious injuries or deaths h...Ver más
Emergencia de salud pública internacional por el ébola
La OMS declara emergencia de salud pública internacional por el ébola.Tras una reunión de dos días, el comité de emergencia de la Organización Mundial de la Salud (OMS) ha decidido por unanimidad que la actual crisis del virus del ébola, la más grave de las últimas cuatro dé...Ver más
Recall: Blood Test Strips
Diabetic Supply of Suncoast, Inc., Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips – Labeling Error May Lead to Use of Incorrect Glucose Meters Recall Class: Class I Date Recall Initiated: June 6, 2014 Products: Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips – All Lots Distribution Dates: January, 2012 – June 6,...Ver más
Opiod painkiller prescribing
46 Each day, 46 people die from an overdose of prescription painkillers* in the US. 259 M Health care providers wrote 259 million prescriptions for painkillers in 2012, enough for every American adult to have a bottle of pills. 10 10 of highest prescribing states for painkillers are in the South.Health issues that cause people pain don't vary much ...Ver más
Penalize about 750 hospitals
Hospitals To Pay Big Fines For Infections, Avoidable InjuriesMedicare is preparing to penalize about 750 hospitals that have the highest rates of infections and patient injuries. The sanctions, estimated to total $330 million over a year, will kick in at a time when most infections and accidents in hospitals are on the decline, but still too common...Ver más
Reacciones de hipersensibilidad
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte sobre reacciones poco frecuentes pero serias de hipersensibilidad a ciertos productos para el acné de uso tópico y venta libre Anuncio de seguridad [6-25-2014] La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA por su sigla en ingl&e...Ver más
Lidocaine Viscous: Drug Safety Communication
ISSUE: FDA notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the prescribing information (label) to highlight this information. Oral viscous l...Ver más
Warning: Products not FDA approved
Medical Supply Liquidators Injectable Vitamin Products With a "Sunshine Labs" Label: Warning - Products Not FDA Approved.ISSUE: FDA alerted health care professionals not to use injectable vitamin drug products distributed by Medical Supply Liquidators LLC in Clive, Iowa, with “Sunshine Labs” on the label. These products are manufactured...Ver más
Mueren 2 personas por Ceftriaxona
Torreón, Coahuila El antibiótico Ceftriaxona que provocó reacciones alérgicas en cuatro pacientes del Hospital General de Torreón, uno de los cuales falleció, podría haber provocado una muerte más. El caso se registró el pasado sábado en el Centro Médico de la Mujer.La Ju...Ver más
Life-Threatening Reactions with Acne Products
FDA Warns Of Life-Threatening Reactions With Acne ProductsThe announcement that popular over-the-counter acne treatments can cause rare but life-threatening reactions sure got our attention. Who among us hasn't slathered that stuff on our face?The reactions include throat tightness, shortness of breath, wheezing, low blood pressure, fainting and co...Ver más
Alerta sobre Phen375
La COFEPRIS en confunto con PROFECO advierten a la población sobre el producto Phen375.El producto Phen375 se publicita como suplemento alimenticio para bajar de peso y carece de registro sanitario que garantice su seguridad, calidad y eficacia.No cuenta con estudios científicos que garanticen el uso que ofrece como reducción d...Ver más
Retirada de 2 lotes de ARGANOVA
La Agencia Española del Medicamento y Productos Sanitarios (AEMPS) ha ordenado laretirada del mercado de 2 lotes de ARGANOVA 100 mg/ml CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN, 1 vial de 2,5 ml.ARGANOVA es un anticoagulante de uso hospitalario, que se utiliza en casos de trombocitopenia de tipo II inducida p...Ver más
Recall of Marcaine (Bupivacaine HCI Injection, USP)
Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible ParticulatesISSUE: Hospira announced a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine (Bupivacaine HCl Injection, USP), 30 mL, Single-dose Vial – Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. ...Ver más
Instituto de Salud Pública de Chile detectó nueva droga sintética
Departamento de Salud Ambiental. Hallazgo es un derivado clorado de la feniletilaminas, y es incluso más potente que el LSD. El Instituto de Salud Pública, informa que se ha detectado un nuevo hallazgo de droga psicodélica sintética en nuestro país, DOC derivado clorado de las feniletilaminas, cuyo nom...Ver más
FDA Takes Final Step on Infant Formula Protections
The Food and Drug Administration (FDA) oversees manufacturers of infant formulas and helps ensure that these products are safe and support healthy growth in infants who consume them.In keeping with that mission, FDA announced on June 9, 2014 that it is finalizing a rule—first published as an interim final rule on February 10, 2014—that ...Ver más
La Jiao Shou Shen Contains Hidden Drug Ingredient
FDA laboratory analysis confirmed that La Jiao Shou Shencontains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may pr...Ver más
Recomendaciones a los profesionales sanitarios ante una ola de calor
Algunos medicamentos pueden agravar el síndrome de agotamiento–deshidratación o de golpe de calor.Recomendaciones generales de la AEMPS a los profesionales sanitarios ante una ola de calor:Revisar la lista de los medica mentos de prescripción médica o de automedicación, utilizados por el pacie...Ver más
FDA Proposes First Regulations for E-Cigarettes
WASHINGTON (AP) — The federal government wants to ban sales of electronic cigarettes to minors and require approval for new products and health warning labels under regulations being proposed by the Food and Drug Administration.While the proposal being issued Thursday won't immediately mean changes for the popular devices, the move is aimed a...Ver más
Recall of Super Arthgold Due to Undeclared Ingredients
http://www.fda.gov/Safety/Recalls/ucm394631.htmFOR IMMEDIATE RELEASE - April 21, 2014 - La Mirada, CA, Nano Well-being Health Inc. is voluntarily recalling lot L1P1-6100/Expiration date June 25, 2016 and lot L1P2-6000/Expiration date September 16, 2016 of Super Arthgold, 500 mg capsules to the consumer level. FDA laboratory analysis has found the p...Ver más