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

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

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

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

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

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

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

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

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

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

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

Dapagliflozin (Forxiga): Indication withdrawn for type 1 diabetes mellitus

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

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

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