Terlipressin safe and effective use recommendations to reduce risks of respiratory failure and septic shock in patients with type 1 hepatorenal syndrome

Drug Safety Updates, Global Safety Alerts, MHRA-United Kingdom, Pharmacovigilance, Safety Communications, ,

MHRA released a drug safety update to disseminate recommendations for safe and effective use of terlipressin. Terlipressin is a synthetic pituitary hormone, an analog of the vasoconstrictor vasopressin which acts by reducing portal venous pressure in the liver, in patients with portal hypertension, and also contributes to improved blood circulation in the kidney helping to…

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Drug Withdrawal Story for Pholcodine containing cough and cold medications

Drug Recall, Drug Withdrawal, EMA-European Medicines Agency, Global Safety Alerts, MHRA-United Kingdom, Pharmacovigilance, PRAC, Risk Minimization Measures, TGA-Australia, ,

Pholcodine is an opioid medicine widely present in many over-the-counter cough syrups, for its antitussive activity. Pholcodine is in market since 1950s and the products containing pholcodine are approved for the following conditions: Treatment of dry cough (non-productive) in adults and children older than 6 years of age. Treatment of symptoms of cold and influenza…

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Decreased vitamin B12 levels with metformin use: MHRA Drug Safety Update

Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, MHRA-United Kingdom, Risk Minimization Measures, ,

MHRA released a safety update for Metformin product related to the new adverse drug reaction- Vitamin B12 Deficiency. Based on the recent review of safety data from brand leader Glucophage (metformin) from the Europe, it was identified that vitamin B12 deficiency is a common adverse drug reaction which may affect up to 1 in 10…

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Measures for minimizing the risk of serious liver injury with Cladribine: MHRA Drug Safety Update

Drug Safety Updates, Global Safety Alerts, MHRA-United Kingdom, Risk Minimization Measures, , ,

To enable safe and effective usage of Cladribine, MHRA released a drug safety update to healthcare professionals and patient/patient care providers to consider the below risk minimizing measures for the serious risk of liver injury. Cladribine is a synthetic purine nucleoside with immunosuppressive effects used in the treatment of highly active relapsing multiple sclerosis. Review…

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Reminder for safe & effective usage of Amiodarone: MHRA Drug Safety Update

Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, MHRA-United Kingdom,

MHRA released a drug safety update for amiodarone to remind healthcare professionals and patient/patient care providers to consider for proactive symptom management of potential organ toxicities [lung, eyes, gastrointestinal tract, nerves, skin, thyroid, heart, and liver] enabling the safe and effective usage of this medicine. Amiodarone is a second-line treatment medication for cardiac dysrhythmias- irregular…

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Additional Risk Minimization measures [updated recommendations] for Safe & Effective usage of Venetoclax (Venclyxto▼)

Drug Safety Updates, Global Safety Alerts, MHRA-United Kingdom, Risk Minimization Measures, Safety Communications, Voluntary ADR reporting, , , ,

Venetoclax is anti-cancer medication used in the treatment of chronic lymphocytic leukemia. This medicine is under additional monitoring with special focus on its safety profile consistency from post-marketing exposure. Tumor lysis syndrome (TLS) is phenomena of release of cellular contents from tumor cells into the blood stream such as uric acid, potassium leading to the…

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Reminder for safe & effective usage of Haloperidol in elderly patients

Global Safety Alerts, Medicinal Product Updates, MHRA-United Kingdom, Risk Minimization Measures, Voluntary ADR reporting,

MHRA reminds healthcare professionals and patients of significant for consideration of recommendation for the safe and effective usage of haloperidol for delirium for elderly patients What needs consider before using haloperidol in a elderly patient for delirium? Second-line treatment: when the first-line non-drug treatments found ineffective, then onlu consider haloperidol for use by adhering to…

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Dapagliflozin (Forxiga): Indication withdrawn for type 1 diabetes mellitus

Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, MHRA-United Kingdom

Dapagliflozin is a sodium glucose co-transporter 2 (SGLT2) inhibitor which decreases glucose level by reducing glucose reabsorption and by increasing urinary glucose excretion. Since 2012, this medicine has been indicated for the treatment of type 2 diabetes and also indicated for the treatment of below conditions in adults Symptomatic chronic heart failure with reduced ejection…

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Ototoxicity associated with aminoglycoside class of medicines – MHRA drug safety update

Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, MHRA-United Kingdom, Voluntary ADR reporting, ,

Aminoglycosides are potent, broad-spectrum class antibiotics which act by inhibition of bacterial protein synthesis. These are traditional antibacterial medications for gram-negative bacterial infections. Antibacterial medicines coming under this class of ‘aminoglycosides’ are gentamicin, amikacin, tobramycin, and neomycin. Medicines and Healthcare products Regulatory Agency (MHRA) – United Kingdom regulatory health authority released a drug safety update…

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An increased risk of postpartum haemorrhage associated with SSRI/SNRI antidepressant medicines

Drug Safety Alert, Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, MHRA-United Kingdom, Pharmacovigilance, Voluntary ADR reporting, , ,

Selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake inhibitors (SNRI) are antidepressant class of medications used in the treatment of depression. They act by increasing the levels of serotonin and norepinephrine in the brain for therapeutic effect. United Kingdom health authority – Medicines and Healthcare products Regulatory Agency (MHRA) released a drug safety…

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