EMA-European Medicines Agency Archives - Page 2 of 2

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

Nov 23, 2020Public Safety & VigilanceBfArM-Germany, Drug Safety Alert, EMA-European Medicines Agency, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Safety Communications, Voluntary ADR reportingDirect Healthcare Professional Communication, Fluoroquinolone antibiotics, Heart valve regurgitation

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

Nov 10, 2020Public Safety & VigilanceDrug Safety Signal, EMA-European Medicines Agency, Global Safety Alerts, PRAC, Signal DetectionAntidepressants, Drug safety signal, Pembrolizumab, Postpartum haemorrhage, PRAC Recommendation, Sjogren's syndrome

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

Oct 15, 2020Public Safety & VigilanceEMA-European Medicines Agency, Global Safety Alerts, Medicinal Product Updates, MHRA-United Kingdom, Pharmacovigilance, Safety CommunicationsDrug safety communication, Medication error, Methotrexate overdose, Risk minimizing measures

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

Aug 10, 2020Public Safety & VigilanceDrug Safety Alert, EMA-European Medicines Agency, Global Safety Alerts, Medicinal Product Updates, NPRA-Malaysia, Pharmacovigilance, Voluntary ADR reportingCutaneous amyloidosis, Drug Safety Alerts, Insulin, NPRA, Topiramate, Uveitis

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:…

Drug Safety Updates from European medicines agency (EMA)-June 2020

Jun 18, 2020Public Safety & VigilanceDrug Safety Alert, Drug Safety Signal, Drug Safety Updates, EMA-European Medicines Agency, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Safety CommunicationsDrug Safety Updates, EMA-June 2020, European Medicines Agency

European medicines agency has released a new Issue (135-June-2020) for medicine updates. The drug safety updates from this issue were discussed below in brief. Fatal Drug Interactions between fluoropyrimidines and brivudine Risk of breast cancer with hormone replacement therapy Potential medication errors with Leuprorelin depot medicines Fatal Drug Interactions between fluoropyrimidines and brivudine European…

Drug Safety Alerts from European medicines agency (EMA)-April 2020

Apr 30, 2020Public Safety & VigilanceDrug Safety Signal, Drug Safety Updates, EMA-European Medicines Agency, Global Safety Alerts, Pharmacovigilance, Safety CommunicationsEMA Drug Safety Updates April 2020, EMA recommendations, Liver injury risk with Ulipristal acetate, Meningioma risk associated with cyproterone use

EMA has released some drug safety updates in its recent Issue 133 April 2020. The safety topics discussed below based on their therapeutic areas. Meningioma risk associated with cyproterone use: Cyproterone is an antiandrogen (blocks the action of androgens, a type of sex hormone found in both men and women) and progestin medication (blocking the…

Ingenol mebutate is having negative benefit to risk ratio: PRAC concludes

Apr 17, 2020Public Safety & VigilanceDrug Safety Updates, Drug Withdrawal, EMA-European Medicines Agency, Global Safety Alerts, HPRA-Ireland, Safety CommunicationsDrug suspension, Drug withdrawal, EMA, Ingenol mebutate, Picato, PRAC Recommendation, skin cancer risk

In a new release from European Medicines Agency (EMA), Pharmacovigilance Risk Assessment Committee (PRAC) stated that ingenol mebutate may increase the risk of skin cancer and concluded that risks for ingenol mebutate medicine are greater than its benefits. On 09-May-2019, PRAC initiated the procedure of review for assessing the benefit risk profile for ingenol mebutate…

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A common platform for safety alerts, news and other important updates for Medicinal Products and Medical Devices from health regulatory authorities across the globe.