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 …
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, …
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. …
The World Health Organization had issued a warning relating to Coronavirus. WHO had feared that the virus would first present its impression in China area or Indian area. But China has been caught by the Coronavirus. On 31 December 2019, WHO was alerted to several cases of pneumonia in Wuhan …
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 …
In many countries, special medicine safety plans may be required as part of a medicine’s approval process and to retain its approved status. These plans are required as per: The International Conference on Harmonisation’s (ICH) Harmonised Tripartite Guideline: Pharmacovigilance Planning—E2E. The European Medicines Agency’s (EMA) Guideline on Risk Management Systems …
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. …
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 …
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 …
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, …
