Alertes de seguretat de fàrmacs
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Proton pump inhibitors moderately increase the risk of small intestinal bacterial overgrowth

The use of proton pump inhibitors (PPIs) may potentially predispose to the development of small intestinal bacterial overgrowth (SIBO), but this association is controversial

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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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Proton pump inhibitors and increased mortality

These findings cast doubt on the harm-benefit balance of long-term and prophylactic PPI therapy. To address these risks, PPI withdrawal must be managed carefully and the use of alternative acid-suppressing agents should be considered.

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Hydrocortisone muco-adhesive buccal tablets and serious risks in children

Risk of insufficient cortisol absorption and life-threatening adrenal crisis if muco-adhesive buccal tablets are used as adrenal replacement therapy.
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Amoxicillin or amoxicillin‐clavulanic acid in males and increased risk for aseptic meningitis

A signal revealed by subset disproportionality analysis within a global database of suspected adverse drug reactions.

 
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Antidepressant medication and risk of self-harm injuries

Clinical trials suggest that antidepressants increase the risk of self-harm injuries.

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Trazodona y riesgo de caídas y fracturas

Trazodona asociado con riesgo de caídas y fracturas, pero otros antipsicóticos atípicos tienen riesgos similares Jack Cush MD, MedPage Today, 1 de diciembre de 2018

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Mélatonine: effets indésirables, en particulier neuropsychiques, cutanés et digestifs

La mélatonine n'est pas un traitement de choix des troubles du sommeil : d'efficacité incertaine au-delà d'un effet placebo.

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Lamotrigina: riesgo de cambios ECG de tipo Brugada y riesgo de linfohistiocitosis

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Quinolone and fluoroquinolone antibiotics and disabling and potentially permanent side effects

16 November 2018 - EMA

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Fluoroquinolones (systemic and inhaled) and small increased risk of aortic aneurysm and dissection

In patients at risk for aortic aneurysm and dissection, fluoroquinolones should only be used after careful assessment of the benefits and risks and after consideration of other therapeutic options....
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SGLT2 inhibitors for diabetes are linked to increased risk of lower limb amputation

Patients with type 2 diabetes treated with sodium glucose cotransporter 2 (SGLT2) inhibitors have a higher risk of lower limb amputation and diabetic ketoacidosis than those who take glucagon-like peptide 1 (GLP1) receptor agonists, a study published in The BMJ has found.

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Alertes de seguretat de fàrmacs - Newsletter 52 (Novembre 2018)

Centre d'Informació de Medicaments de Catalunya (CedimCat) http://www.cedimcat.info

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Ustekinumab and noninfectious pneumonia

This study examines the FDA Adverse Event Reporting System and PubMed databases for cases of noninfectious pneumonia acquired after FDA approval of the drug ustekinumab.
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Direct-acting antivirals for chronic hepatitis C and risk of hypoglycaemia in patients with diabetes

Monitor glucose levels closely in patients with diabetes during direct-acting antiviral therapy for hepatitis C, particularly within the first 3 months of treatment, and modify diabetes medication or doses when necessary.
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Fluoroquinolone antibiotics and increased risk of ruptures or tears in the aorta blood vessel

FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.
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Alertes de seguretat de fàrmacs - Newsletter 53 (Desembre 2018)

Centre d'Informació de Medicaments de Catalunya (CedimCat) http://www.cedimcat.info

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Tamoxifen and increased risk of hip fractures in older women with breast cancer

Tamoxifen use is associated with increased risk of hip fractures among older women with breast cancer in Taiwan. Geriatr Gerontol Int 2018

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Gabapentin and Pregabalin and risk of atrial fibrillation in the elderly

Introduction Gabapentin and pregabalin are widely prescribed to elderly people, but data on their pharmacokinetics, safety, and efficacy in this population are scarce. Neurological adverse effect
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Pregabalin and gabapentin associated with depression and suicidal ideation

Abuse of pregabalin and gabapentin for their euphoric effects may only be part of the story.1

Pregabalin …
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Hydrochlorothiazide and risk of non-melanoma skin cancer, particularly in long-term use

Advise patients taking hydrochlorothiazide-containing products of the cumulative, dose-dependent risk of non-melanoma skin cancer, particularly in long-term use, and the need to regularly check for (and report) any suspicious skin lesions or moles.
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Gilenya (fingolimod) and severe worsening of multiple sclerosis after stopping the medicine

FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.
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Inhaled corticosteroids and risk of pneumonia in patients with chronic obstructive pulmonary disease

The use of inhaled corticosteroid (ICS) in patients with chronic obstructive pulmonary disease (COPD) decreases the frequency of COPD exacerbations. Recently, pneumonia was reported as a complication of ICS in patients with COPD. However, there have bee
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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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