Public Safety & Vigilance, Author at Public Safety & Vigilance

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…

Potential risk of congenital malformations with the use of Modafinil during pregnancy

Nov 11, 2020Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, HPRA-Ireland, Medicinal Product Updates, Voluntary ADR reportingCongenital malformations, Drug safety alert, HPRA, Modafinil

Ireland Health authority, Health Products Regulatory Authority – HPRA has released a drug safety alert for modafinil association with congenital malformations (congenital heart defects, hypospadias and orofacial clefts) in foetus when exposed to a pregnant woman or to women of childbearing potential. Modafinil is a wakefulness promoting medicinal product used in the treatment of too…

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…

Pirfenidone induced liver injury: Drug safety alert from Norwegian Medicines Agency

Nov 9, 2020Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, Norwegian Medicines Agency, Voluntary ADR reportingDrug safety alert, HCP letter, Norwegian Medicines Agency, Pirfenidone, Severe Liver injury

Pirfenidone used in the treatment of idiopathic pulmonary fibrosis (scarring of the lung tissue). It is an inhibitor of transforming growth factor (TGF)-beta (a factor which is involved in the proliferation and differentiation of cells) and it also inhibits the TNF-Alpha. Norway health authority (Norwegian Medicines Agency) identified a new safety alert for pirfenidone from…

Lack of Heparin drug efficacy due to interaction with Andexane alpha

Nov 7, 2020Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, Medicinal Product Updates, Norwegian Medicines Agency, PharmacovigilanceAndexane alpha, Drug-drug interaction, Heparin, Lack of drug efficacy

Norwegian Medicines Agency (health authority of Norway) published a drug safety alert of drug ineffectiveness for heparin due to interaction with andexane alpha. To foster awareness, this significant safety information is disseminated to health care professionals for early implementation of risk minimizing measures. Andexanet alpha is a recombinant modified factor Xa protein for the reversal…

Oligohydramnios associated with NSAID use in Pregnancy-Safety Communication from USFDA

Nov 5, 2020Public Safety & VigilanceDrug Safety Alert, Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Safety Communications, US-FDA, USFDA-United States of AmericaNSAID, Oligohydramnios, Pregnancy, USFDA Drug Safety Communication

United States Food and Drug Administration (US-FDA) has issued a safety communication on the potential risk of oligohydramnios in pregnant women when exposed to medicinal products that belongs to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) during pregnancy of 20 weeks gestational age. FDA issued this communication to alert health care professionals and consumers for…

Dimethyl fumarate induced Alopecia areata: Drug Safety Alert from Netherlands Pharmacovigilance Center (LAREB)

Oct 19, 2020Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, Medicinal Product Updates, Netherlands-LAREB, Pharmacovigilance, Signal DetectionAlopecia areata, Dimethyl fumarate, Drug safety alert, Lareb

A new drug safety signal “Dimethyl fumarate included Alopecia areata” identified by Netherlands Pharmacovigilance center, Lareb Dimethyl fumarate is an anti-inflammatory and immunomodulatory agent which is used in the treatment of relapsing multiple sclerosis and plaque psoriasis. Alopecia areata is an autoimmune disorder which involves loss of hair follicle with one or more circular bald…

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…

Tocilizumab and Cutaneous Vasculitis: A Drug Safety Signal from WHO-UMC

Oct 14, 2020Public Safety & VigilanceDrug Safety Signal, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Signal Detection, WHOCutaneous Vasculitis, Drug safety signal, Tocilizumab, WHO's VigiBase Signal

This is the third drug safety signal – “Cutaneous Vasculitis association with Tocilizumab use” detected from the VigiBase by the UMC (Uppsala Monitoring Center). UMC is a WHO Collaborating Centre present in Sweden for international service and scientific research within the field of pharmacovigilance. Tocilizumab is an immunosuppressive agent and a biologic medication (fully human…

Alectinib – Rhabdomyolysis: A Drug Safety Signal from WHO-UMC’s VigiBase Database

Oct 13, 2020Public Safety & VigilanceDrug Safety Signal, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Signal Detection, WHOAlectinib, Drug safety signal, Rhabdomyolysis, WHO's VigiBase Signal

A new drug safety signal- “Rhabdomyolysis association with Alectinib” identified by the UMC (Uppsala Monitoring Center), from the VigiBase, a global drug safety database maintained by UMC on behalf of WHO. UMC is a WHO Collaborating Centre present in in Sweden for international service and scientific research within the field of pharmacovigilance. Alectinib is an…

Public Safety & Vigilance

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