Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. N‑Nitrosodimethylamine (NDMA) is classified as a probable human carcinogen (a substance with potential to cause cancer) based on results from laboratory tests. With the release of alert of NDMA presence in Metformin…
A new drug safety alert (Hydroxychloroquine-Moth Ulceration) released by the Pharmacovigilance Programme of India (PvPI) from Indian Pharmacopoeia commission (IPC) Mouth Ulceration associated with Hydroxychloroquine use Hydroxychloroquine is an antimalarial class of drug which is used in the treatment and prevention of acute attacks of malaria. It also used to treat discoid or systemic lupus…
Below Safety Updates for medicinal products were released for the month of May-2020 by Ireland Health Authority-Health Products Regulatory Agency (HPRA) A confirmed “Negative Benefit-Risk Profile” for Picato (ingenol mebutate) Risk of abnormal and aggressive behaviors with Levetiracetam use Restricted use of Cyproterone acetate due to risk of meningioma Restricted use of thyroid drugs…
The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released a new drug safety alert for nintedanib. Nintedanib is a small molecule tyrosine kinase inhibitor (TKI) indicated for the treatment of idiopathic pulmonary fibrosis in adults and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung…
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…
Food and Drug Administration (FDA) in the United States announced a serious safety concern on the use of hydroxychloroquine or chloroquine for the treatment of 2019 Coronavirus Disease (COVID-19) due to abnormal heart rhythms like QT prolongation and ventricular tachycardia. Currently, there are no medicines proven effective for the treatment of COVID-19. On 28‑Mar‑2020, FDA released…
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)…
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…