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

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

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

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

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

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

Reminder for safe & effective usage of Haloperidol in elderly patients

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

DHPC from Novartis: Updated recommendations to minimize the known risk of intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion

Drug Safety Communication pertaining to the safe & effective use of Beovu® (brolucizumab) released from Novartis via a direct healthcare professional communication (DHPC) letter for the implementation of updated recommendations based on the recent safety evidence from MERLIN Study (Interventional clinical trial being conducted for the comparison of Safety and Efficacy of Brolucizumab to Aflibercept

Reminder for importance of adhering to risk minimization measures for the safe and effective usage of Direct oral anticoagulants (DOACs)

Direct oral anticoagulants (DOACs) are the medications used in the prevention of thrombosis in several cardiovascular contexts viz. in the treatment and prevention of blood clots in veins, and for the prevention of stroke and embolism in people with atrial fibrillation. DOACs are direct factor Xa (activated factor X) inhibitors which included apixaban (Eliquis and

DHPC – Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy

European Medicine Agency (EMA) released a direct healthcare professional communication (DHPC) pertaining to the risk of thrombotic microangiopathy (TMA) associated with Zolgensma gene therapy to bring increased awareness of TMA for patients receiving onasemnogene abeparvovec. Zolgensma (onasemnogene abeparvovec) is a gene therapy medication used in the treatment of spinal muscular atrophy indicated for children of

An unfavourable benefit-risk profile for Ulipristal acetate 5 mg: A drug withdrawal story

Ulipristal acetate is a selective progesterone receptor modulator which acts by preventing the effects of the female progesterone hormone. This medicine is available in two brand names in market for the below two different therapeutic uses. Esmya® tablets comprising 5 mg ulipristal acetate and therapeutically indicated for Uterine fibroids. It is used for the treatment

Risk of progressive multifocal leukoencephalopathy with Tecfidera (dimethyl fumarate): DHPC from Biogen

Biogen released a direct healthcare professional communication (DHPC) pertaining to the risk of progressive multifocal leukoencephalopathy (PML) associated with Tecfidera (dimethyl fumarate) to alert healthcare professionals for safe usage of this medicine and implementing the recommended risk minimizing measures. This DHPC released in agreement with European Medicines Agency (EMA) and national health authority of Ireland

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