Month: January 2020
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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…
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Safety alert: Recall of Lamotrigine Tablets
Taro Pharmaceuticals U.S.A., Inc is voluntarily recalling one lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level. This single lot of Lamotrigine 100 mg Tablets Lot #331771 (expiration date June 2021) was found to have been cross-contaminated with a small amount…
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Recall of heartburn medication Nizatidine
Mylan N.V. announced a recall of three lots of Nizatidine, which is used to treat duodenal ulcers and acid reflux. Trace amounts of NDMN-(N- nitrosodimethylamine) found in the drug, which was manufactured by Solara Active Pharma Sciences Limited. Nizatidine is indicated for the short-term treatment (up to 8 weeks) of active duodenal ulcers and active…
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FDA approved Antifungal Injectable Drug for Newborns
The FDA approved the first antifungal drug to specifically treat invasive candidiasis in the youngest of infants. The candidiasis in newborns is tied to a 20% mortality rate and is associated with significant morbidity as well. Candidiasis is a fungal infection caused by a yeast (a type of fungus) called Candida. Some species of Candida can cause infection…
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Safety alert: Ondansetron – Should Not Be Used During The First Trimester Of Pregnancy To Treat Nausea And Vomiting
Ondansetron is a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery. It is also useful in gastroenteritis. Ondansetron has also been prescribed during pregnancy to reduce symptoms of nausea and vomiting in pregnancy (NVP). NVP is also referred to as “morning sickness”. Ondansetron is commonly sold under the…
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39. Evaluation of benefits
All drugs have an effect on our body: part of the effect is desired (to prevent, treat or cure a given disease, or ameliorate its symptoms), but part of the effects may be undesired (adverse events). A medicine is authorised to be used in humans when regulators estimate that the desired effects on the disease…
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Safety Alert: Serious immune system reaction with seizure and mental health medicine Lamotrigine
Lamotrigine is an anti-convulsant medication to treat seizures in epileptic patients. It is also used to control extreme mood swings in bipolar disorder – a medical condition that results in unusual shifts of mood, energy levels and the ability to carry out day-to-day tasks. Lamotrigine works by restoring a balance of certain natural substances in…
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38. Risk benefit evaluation process – Overview
Benefit-risk assessment is the continuous examination (at all phases preclinical, clinical and post marketing) of the favourable and unfavourable results of a specific treatment to determine whether its benefits outweigh its risks in a specific condition. The benefit and risk profile of medicines have dual aspects. In some cases, new findings indicate the better safety…
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Recall alert – Mavidon skin preparation products
Mavidon is recalling all lots of Lemon Prep, Pedia Prep, Wave Prep, Cardio Prep Single use cups, Collodions, Collodion Remover, Medical Adhesive Remover, Acetone and all products manufactured by Mavidon immediately due to contamination with multi-drug-resistant Burkholderia cepacia, a bacteria that may cause serious infection. The company has received one report of an adverse event…
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WHO prequalifies first biosimilar medicine – trastuzumab
What is biosimilar medicine? Biotherapeutic medicines are produced from biological sources such as cells rather than synthesized chemicals, are important treatments for some cancers and other non-communicable diseases. Like generic medicines, biosimilars can be much less expensive versions of innovator biotherapeutics while keeping the same effectiveness. They are usually manufactured by other companies once the…