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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...

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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 ...

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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 ...

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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...

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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...

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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...

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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...

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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...

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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...

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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 ...

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