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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Risk of severe hypocalcaemia with denosumab (Prolia): USFDA Drug safety communication

Drug Safety Alert, Drug Safety Updates, Global Safety Alerts, Safety Communications, US-FDA, USFDA-United States of America, Voluntary ADR reporting, ,

USFDA released a recent safety update for the denosumab Denosumab is a human monoclonal antibody which helps in preventing breaking down of bone cells (osteoclasts) from bone by inhibiting the receptors named – RANK (receptor activator of nuclear factor kappa beta) in the body. This medicine is intended for the treatment of following medical conditions: Osteoporosis…

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Potential increased risk of death and serious adverse effects with cancer medicine Copiktra (duvelisib): USFDA Drug safety communication

Drug Safety Updates, Global Safety Alerts, Safety Communications, US-FDA, , ,

USFDA released a recent safety update for the duvelisib, which is used in the treatment of blood cancer – chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is a PI3 kinase inhibitor, which controls the multiplication and growth of cancer cells by blocking the signaling action of abnormal protein. After the product approval…

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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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Withdrawal of FDA approval for cancer medicine-Umbralisib due to unfavorable benefit-risk profile: USFDA Drug safety communication

Drug Withdrawal, Global Safety Alerts, Safety Communications, USFDA-United States of America, ,

In continuation to the recent drug safety communication for umbralisib in Feb-2022, USFDA further released a drug safety communication pertaining to the withdrawal of approval for umbralisib. Ukoniq (umbralisib) is a cancer medicine used in the treatment of below two specific types of lymphomas. It is a PI3 kinase inhibitor, which controls the multiplication and…

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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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Umbralisib and potential increased risk of death [under USFDA investigation]: Need for consistent evaluation of benefits & risks

Drug Safety Alert, Global Safety Alerts, Medicinal Product Updates, Safety Communications, US-FDA, USFDA-United States of America,

USFDA released a drug safety communication for the updated significant safety information of the cancer medicine – umbralisib to disseminate awareness for optimal, safe & effective usage of this product in patients suffering from cancer of the lymph nodes and respective healthcare professionals involved in treating this patients. Ukoniq (umbralisib) is a cancer medicine used…

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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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