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A medicine with negative benefit to risk ratio has withdrawn from the US market.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

Sleep Disorder (Insomnia) association with Vitamin D3 supplements: A Drug Safety Signal

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

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

Ranitidine drug status in India: Is it still used?

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

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

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

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

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