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

Metamizole induced liver injury: Direct health care professional communication (DHPC)

European Medicines Agency (EMA) released a direct health care professional letter (DHPC) pertaining to the risk of drug-induced liver injury (DILI) by metamizole. We encourage all health care professionals to be aware of this new safety alert and to disseminate this significant information to the relevant stakeholders for a better patient safety. Metamizole (also known

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

TRISENOX (arsenic trioxide) and potential medication errors: DHPC from Teva Pharmaceuticals

Arsenic trioxide is a chemotherapeutic medication used in the treatment of newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) and relapsed/refractory APL characterized by the presence of leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene. The initial approved formulation available in market for arsenic trioxide is 1 mg/ml single-use 10 ml of glass ampoule (This formulation comprises 10 mg of

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

Fingolimod induced liver injury : DHPC from Novartis

A direct health care professional communication (DHPC) released by Novartis in liaison with European medicines agency (EMA) and some of national competent authorities in Europe to disseminate important safety information pertaining to drug (fingolimod) induced liver injury to alert healthcare professionals for a careful benefit -risk analysis and early implementation of risk minimization measures for

Risk of heart valve regurgitation/incompetence with systemic and inhaled fluoroquinolones: Direct Healthcare Professional Communication

German Health Authority – Federal Institute for Drugs and Medical Devices, released a safety alert for fluoroquinolone antibiotics for the potential risk of heart valve regurgitation. This is a direct healthcare professional communication released by marketing authorisation holder of respective medicinal products in liaison with European Medicines Agency (EMA) to inform health care professionals on

Drug Safety Signals from Pharmacovigilance Risk Assessment Committee (PRAC)-EMA

Pharmacovigilance Risk Assessment Committee (PRAC), which is responsible for assessing and monitoring the safety of human medicines from European medicines agency (EMA) has published new significant safety information (signals) for medicines which were identified from their monthly PRAC meeting held during the period of 28 Sep-2020 to 01 Oct 2020. PRAC Recommendations for regulatory action

Potential medication error and unintentional overdose associated with methotrexate use

Methotrexate is an immunosuppressant medication used in the treatment of autoimmune diseases and some type of cancers. It acts by competitively inhibiting the dihydrofolate reductase (DHFR), a key enzyme involved in the synthesis of DNA, RNA, thymidylates, and proteins. Different regulatory bodies issued alerts on the safety concerns of medication errors and fatal overdose occurrences

Drug Safety Alerts from Malaysian Health Authority-August 2020

Drug Safety Alerts from Malaysian Health Authority-August 2020

The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released the following new drug safety alerts for bringing awareness to health care professionals for a better patient safety. Drug Safety Alert 1: Risk of cutaneous amyloidosis with Insulin Drug Safety Alert 2: Risk of uveitis with Topiramate   Drug Safety Alert 1:

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