Drug Safety Updates Archives - Page 6 of 6

EMA (PRAC) Recommends new testing procedure before treatment with fluorouracil, capecitabine, tegafur and flucytosine

Apr 23, 2020Public Safety & VigilanceDrug Safety Updates, Pharmacovigilance, Safety Communicationscapecitabine, Dihydropyrimidine dehydrogenase, DPD deficiency screening, flucytosine, fluorouracil, PRAC Recommendation, tegafur

European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) recommended a test for identification of the “lack or inadequate presence of an enzyme, dihydropyrimidine dehydrogenase (DPD)” in the body before receiving treatment with fluorouracil (by injection or infusion) and the its prodrugs which included capecitabine and tegafur (these drugs are converted to fluorouracil in the body)…

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…

Drug Safety Alerts from Malaysian Health Authority

Apr 17, 2020Public Safety & VigilanceDrug Safety Alert, Drug Safety Signal, Drug Safety Updates, Global Safety Alerts, NPRA-Malaysia, Pharmacovigilance, Safety CommunicationsDrug Safety Alerts, Malaysian Health Authority Safety Update, NPRA

The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released the following new drug safety alerts. Drug Safety Alert 1: Risk of anaphylaxis associated with Guselkumab use Drug Safety Alert 2: Kounis syndrome associated with Intravenous iron-containing products Drug Safety Alert 3: Reports of cytomegalovirus (CMV) infection or reactivation with Nivolumab use…

Withdrawal Story of Weight Loss Medicine (A scenario to understand the benefit risk balance of a medicine)

Apr 15, 2020Public Safety & VigilanceDrug Safety Updates, Drug Withdrawal, Global Safety Alerts, Safety Communications, USFDA-United States of AmericaBelviq, Cancer Risk, Diet pILL, Drug withdrawal, lorcaserin, Obesity Drug, Weight loss medication

A medicine with negative benefit to risk ratio has withdrawn from the US market. (Belviq) lorcaserin is a weight loss medication developed by Arena Pharmaceuticals approved for treating obesity together with diet and exercise in adults with a body mass index (BMI) of 30 or greater (obese), or adults with a BMI of 27 or…

Hydroxychloroquine: A potential therapy for COVID-19?

Apr 12, 2020Public Safety & VigilanceClinical trial study, Drug Safety Updates, Global Safety Alerts, Safety Communications, USFDA-United States of AmericaClinical trial studies, COVID-19 Potential therapy, Hydroxychloroquine

Coronavirus disease 2019 (COVID-19), a global pandemic which is affecting human beings with an acute respiratory infectious illness by damaging multiple organ systems, including heart, lung, and blood. Most adults with COVID-19 experience fever, cough, and fatigue and then recover within one to three weeks. However, it becomes fatal for some patients who develop severe…

Drug Recall story of Ranitidine (An established drug since 3 decades)

Apr 3, 2020Public Safety & VigilanceDrug Recall, Drug Safety Updates, Global Safety Alerts, Pharmacovigilance, Safety Communications, USFDA-United States of AmericaDrug Recall, Drug safety alert, patientsafety, Ranitidine, USFDA alerts, Zantac

A medicine having been considered as “Safe” since 1981 is recalled from the drug market. It’s not a surprise on recall of a drug from market which has an “assumed established safety profile”. Ranitidine, popularly known to public as Zantac, is a very common OTC (over the counter) drug and prescription stomach acid blocker widely…

The risk of skin cancer associated with Ingenol mebutate: Suspension of Ingenol mebutate use during PRAC review period.

Mar 31, 2020Public Safety & VigilanceDrug Safety Updates, Pharmacovigilance, Safety CommunicationsEMA, HPRA, Ireland Health Authority

Ingenol mebutate, which is commonly known as milkweed is indicated for the cutaneous treatment of non-hyperkeratotic, non‑hypertrophic actinic keratosis in adults. The health authority of Ireland has cautioned patients and health care professionals on the use of this product in patients having history of skin cancer. It was reported in a randomized study results in…

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.