NPRA’s Drug Safety Alert: Ischaemic colitis associated with Nintedanib use

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


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

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

USFDA’s Drug Safety Communication: Caution on COVID-19 medication

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

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

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

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

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

Voluntary Recall of Nizatidine products from US market

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

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

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?

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)

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

error: Content is protected !!