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…
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…
Amneal Pharmaceuticals announced recall of nizatidine oral solution, 15 mg/mL, due to presence of potential levels of N-Nitrosodimethylamine (NDMA) impurity, (a probable human carcinogen). Nizatidine is a similar drug to Ranitidine which is commonly used in the treatment of peptic ulcer disease and gastroesophageal reflux disease. It acts as antagonists for histamine (H2) receptor, thereby…
A medicine with negative benefit to risk ratio has withdrawn from the US market.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…
Vitamin D3 (colecalciferol) supplements are quite commonly used medications for vitamin D deficiency by all age groups especially in elderly women and young children. It also used to treat and prevent bone disorders like rickets, osteomalacia. Colecalciferol is the natural precursor of the calcium-regulating hormone calcitriol, which plays an important role in regulating calcium and…
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…
Ranitidine has an Indian market size of Rs 750 crore which is also commonly used OTC and prescription medicine by wide range of patients (pediatrics, adults and the elderly patients) commonly used for intestinal and stomach ulcers, Gastroesophageal Reflux Disease (GERD), esophagitis, Zollinger-Ellison syndrome etc., It is a H-2 blocking agent, which decreases the amount…
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…
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…
The periodical reporting of aggregate safety reports to regulatory health authorities includes a comprehensive overview of the safety profile of medicinal product based on cumulative safety information accumulated by Marketing Authorization Holder (MAH). They also provide assurance that the MAH is continuously monitoring and critically assessing the benefit-risk profile of the product and taking appropriate…