Category: Drug safety alert
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FDA request withdrawal of bacitracin injection
The U.S. Food and Drug Administration has requested that all current manufacturers of bacitracin for injection voluntarily withdraw their product from the market. Bacitracin for injection is currently FDA-approved to treat infants with pneumonia and empyema (a collection of pus in the space between the membranes lining the lungs) caused by staphylococci, a type of…
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Safety alert: Mecasermin (Increlex): risk of benign and malignant neoplasia
Mecasermin is a recombinant human insulin-like growth factor 1 (rh-IGF-1). It is indicated for the long-term treatment of growth failure in children and adolescents aged 2–18 years with confirmed severe primary insulin-like growth factor 1 deficiency (primary IGFD). The recommended maximum dose is 0.12 mg/kg given twice a day. An EU review identified an increased…
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Safety alert: multiple sclerosis medicine Lemtrada
European Medicine Agency (EMA) is recommending restriction of the use of the multiple sclerosis medicine Lemtrada (alemtuzumab) due to reports of rare but serious side effects, including deaths. New measures to identify and manage the serious side effects are also recommended. The side effects include cardiovascular disorders (affecting the heart, circulation and bleeding as well…
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Temporarily discontinued Migraine medication
Two over-the-counter medicines that many headache and migraine sufferers rely on, Excedrin Extra Strength and Excedrin Migraine were temporarily discontinued. Excedrin Extra Strength is used for temporary pain relief due to headaches, arthritis, and muscle aches; and Excedrin Migraine claims to help relieve pain in as little as 30 minutes. According to a statement from…
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Drug To Prevent Premature Birth can be pull off from the market
The FDA approved 17-hydroxyprogesterone caproate (Makena) in 2011 as a way to prevent preterm birth in women with a prior spontaneous preterm birth. The drug got the green light through the FDA’s accelerated approval pathway, which is reserved for drugs that treat a serious or life-threatening disease or condition. That certainly applies to preterm birth…
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Fatal adverse events associated with PD-L1 inhibitors
What are PD-L1 inhibitors? PD-L1 (programmed cell death ligand 1) inhibitors are a group of checkpoint inhibitors being developed for the treatment of cancer. It is protein present on the surface of cells. Immune checkpoint inhibitors such as these are emerging as a front-line treatment for several types of cancer. Examples of PD-L1 inhibitors: Atezolizumab…
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Recall alert: Antifungal drug PMS-Nystatin Oral Suspension: Product may pose a choking risk
Issue: Health Canada is advising Canadians that Pharmascience Inc. is recalling one lot of PMS-Nystatin Oral Suspension, because it may contain clumps or jelly-like material that may pose a choking risk. Newborns, infants and people with difficulty swallowing are particularly at risk. PMS-Nystatin Oral Suspension normally contains small visible particles and, as noted in the…
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Safety alert: Don’t Use Estradiol Creams for Longer Than 4 Weeks
European Medicine Agency’s safety committee (PRAC) has confirmed its recommendation to limit the use of high-strength creams containing 100 micrograms/gram (0.01%) of estradiol to a single treatment period of up to 4‑weeks. What are estradiol-containing creams? The estradiol-containing creams are a type of topical hormone replacement therapy. They contain the female hormone estradiol, used to…
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Safety alert: EMA suspends Picato as a precaution while review of skin cancer risk continues
EMA’s safety committee (PRAC) recommended that patients stop using Picato (ingenol mebutate) manufactured by LEO Pharma, a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety. The PRAC is currently reviewing data on skin cancer in patients using Picato. While uncertainties remain, there is concern about a…
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Safety alert: Weight Loss Drug Possibly Linked to Cancer
The FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin). Lorcaserin is a prescription medicine approved by FDA in 2012 for use with a reduced-calorie diet and increased physical activity to help weight loss in…