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

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

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

Dapagliflozin (Forxiga): Indication withdrawn for type 1 diabetes mellitus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

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 microscopic colitis with sertraline: TGA Drug Safety Alert

Safety update: Potential risk of microscopic colitis associated with the use of sertraline. Sertraline is antidepressant medication marketed under the brand name Zoloft and multiple generic brands. It acts as a selective serotonin re-uptake inhibitor (SSRI) with the below therapeutic indications: Treatment of obsessive compulsive disorder (OCD) in children and adolescents (aged 6 years and

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