Alertes de seguretat de fàrmacs
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Alertes de seguretat de fàrmacs
Monitorització d'alertes de seguretat de fàrmacs. Seguretat clínica a recepta electrònica. Centre d'Informació de Medicaments de Catalunya (CedimCat) http://www.cedimcat.info
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Opioid Analgesics and Risk of Major Depression

More than 200 million prescriptions are written annually for opioid analgesics despite limited evidence of their long-term efficacy. These medications currently are prescribed to 10% - 15% of Americans with use of long-acting opioids projected to double in the next three to four years. Despite this widespread use, little is known about the risks of opioids.

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ACE inhibitors and cancer risk

Angiotensin converting enzyme inhibitors (ACEIs) are associated with a higher risk of lung cancer than angiotensin receptor blockers (ARBs), especially if used for more than five years, a study in The BMJ has found.

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Androgen deprivation therapy and risk of heart failure in patients with prostate cancer

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Drug-induced gynaecomastia

 Drug-related proliferation of male breast tissue generally subsides after discontinuation of the substance that caused it. This must be weighed against the potential disadvantages of stopping treatment or substituting another drug.

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Quinolonas-fluoroquinolonas y reacciones adversas musculoesqueléticas y del sistema nervioso: restricciones de uso

Tras la evaluación realizada en el PRAC se ha concluido que las reacciones adversas musculoesqueléticas y del sistema nervioso, incapacitantes, de duración prolongada, y potencialmente irreversibles, afectan a todas las quinolonas y fluoroquinolonas, constituyendo un efecto de clase.

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Alertes de seguretat de fàrmacs - Newsletter 51 (Octubre 2018)

(CedimCat) http://www.cedimcat.info

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Fluoroquinolone and quinolone and disabling, potentially long-lasting side effects: restrictions on use

Press release 05/10/2018

"EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics (used by mouth, injection or inhalation) following a review of disabling and potentially long-lasting side effects reported with these medicines."

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Brivudina y f-fluoropirimidinas interacción potencialmente mortal title

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Oral ciprofloxacin, levofloxacin, ofloxacin and moxifloxacin with the risk of serious ventricular arrhythmia

Objective To evaluate whether oral ciprofloxacin, levofloxacin, ofloxacin and moxifloxacin increase the risk of ventricular arrhythmia in Korea’s general population.

Design Population-based cohort study using administrative claims data on a national scale in Korea.
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Daclizumab beta (Zinbryta▼) and risk of immune-mediated encephalitis – some cases several months after stopping treatment

Monitoring for encephalitis should continue for 12 months following discontinuation of daclizumab. Inform all patients who have discontinued daclizumab and their caregivers of the common symptoms of encephalitis and the need to contact their doctor immediately if they occur.
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Alertes de seguretat de fàrmacs - Newsletter 50 (Setembre 2018)

CedimCat http://www.cedimcat.info

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Esmya (ulipristal acetate) and risk of serious liver injury

More than one treatment course is authorised only in women who are not eligible for surgery, and liver function monitoring is to be carried out in all women treated with Esmya. Before initiation, discuss with women the rare risk of liver damage and advise them to seek urgent medical attention if...
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SGLT2 Inhibitors for diabetes and rare occurrences of a serious infection of the genital area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.
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XOFIGO® and increased incidence of fractures when used with abiraterone and prednisone/prednisolone

An increased incidence of fractures and a trend for increased deaths was observed in a clinical trial assessing the concurrent initiation of XOFIGO in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients...
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Denosumab and serious adverse effects

Reports of sometimes serious adverse effects tilt the harm-benefit balance of denosumab in the treatment of osteoporosis.

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Metamizol y riesgo de agranulocitosis

Tras la revisión de los casos de agranulocitosis notificados en el Sistema Español de Farmacovigilancia y el consumo de metamizol en España, la AEMPS recuerda que los medicamentos que contienen metamizol son medicamentos sujetos a prescripción.

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Hidroclorotiazida (uso continuo y prolongado) y riesgo de cáncer cutáneo no melanocítico

"Hidroclorotiazida: el uso continuo y prolongado en el tiempo podría aumentar el riesgo de cáncer cutáneo no melanocítico."

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Bezlotoxumab (Zinplava°) & recurrence of C. difficile infection and cardiotoxicity

"In patients undergoing antibiotic therapy for an episode of Clostridium difficile infection, the addition of a single infusion of bezlotoxumab reduces the risk of recurrence of C. difficile-associated diarrhoea within 3 months from about 27% with placebo to about 16%. Bezlotoxumab has not been properly evaluated in patients at high risk of recurrence. It increases the risk of heart failure."

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Inhibiteurs de la pompe à protons: éviter leur utilisation à long terme''

"Les inhibiteurs de la pompe à protons (IPP) tels que l'oméprazole ont des effets indésirables graves à long terme qui incitent à ne pas banaliser leur utilisation et à éviter leur utilisation à long terme."

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Atezolizumab ( Tecentriq®) and risk of immune-related nephritis

Cases of immune-related nephritis have been reported in cancer patients receiving TECENTRIQ treatment. As of 31 May 2018, there were a total of 28 cases including 13 biopsy confirmed cases in which atezolizumab played a potential role in the development of nephritis.
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Lenalidomide and increased risk of ischemic stroke in multiple myeloma

Clin Neuropharmacol. 2018 doi: 10.1097/WNF.0000000000000310. [Epub ahead of print]

A case report and review of the literature

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Hidroxietil-almidón y insuficiencia renal - mortalidad

Soluciones de hidroxietil-almidón: conclusiones de la revisión realizada. Acceso controlado y obligación de seguir estrictamente las condiciones de uso autorizadas

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SGLT2 inhibitors and risk of acute and chronic pancreatitis

SGLT2 inhibitors (canagliflozin, dapagliflozin and empagliflozin)

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