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

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

Risk of Respiratory depression with Pregabalin: Drug Safety Alert from Europe Medicines Agency

Safety Alert: Serious risk of respiratory depression associated with the use of pregabalin even without concomitant use of opioid medications or other CNS depressants. Health Authority: Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) Pregabalin-containing medicinal products are marketed under various brand names for the treatment of following conditions: Generalized anxiety disorder

Pigmentary maculopathy associated with long term use of Pentosan polysulfate sodium

Pentosan polysulfate sodium is a semi-synthetically produced heparin which has anticoagulant and fibrinolytic effect. It is used in the treatment of bladder pain and discomfort caused by cystitis (bladder inflammation or irritation). Product information (PI) of Pentosan polysulfate sodium (‘Section 4.4 Special Warnings and Precautions for Use’ and ‘Section 4.8 Adverse Effects’) are updated with

Propylthiouracil and Carbimazole: Product label update of Pregnancy category from “C” to “D”

Propylthiouracil and Carbimazole are the medications used in the treatment of hyperthyroidism. The product information (PI) documents which were previously having status of category “C” for use in pregnant women is being updated to category “D” Category C status: Based on the mechanism of action & pharmacological activity, suspicion of causing harmful effects to the

Hypertension risk associated with Erenumab use: TGA safety alert

Product Information (PI) for Erenumab has been updated with the below statements- A warning about a potential causal relationship between the drug and hypertension under the ‘Special Warnings and Precautions’ section (Section 4.4) of the PI. Addition of hypertension under ‘Vascular disorders’ in the ‘Adverse Effects’ section (Section 4.8). Erenumab is a fully human monoclonal

Risk of agranulocytosis with minocycline antibiotic

Safety update: Product Information (PI) for minocycline is in the process of being updated to include information about agranulocytosis, a rare but potentially life-threatening adverse event. Minocycline is a tetracycline antibiotic that may be used to treat acne that is resistant to other antibiotics, as well as various other susceptible infections. Agranulocytosis is a serious

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