Category: Medication Alerts
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FDA Approves Lactitol for Chronic Idiopathic Constipation in Adults
The US Food and Drug Administration (FDA) has approved a new treatment for chronic idiopathic constipation (CIC). The approval allows Braintree Laboratories to move forward with lactitol (Pizensy), an osmotic laxative indicated for the treatment of CIC in adults for a recommended dosage of 20 grams orally daily. The FDA suggests reducing the dosage to 10 grams…
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Safety Alert: Modafinil: potential risk of congenital malformations during pregnancy
Modafinil is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy, with or without cataplexy. Based on post-marketing reports from the US Nuvigil and Provigil Pregnancy Registry and other spontaneous sources, use of modafinil during pregnancy is suspected to cause congenital malformations (including congenital heart defects, hypospadias, and orofacial clefts) As per…
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EMA recommends restrictions in use of cyproterone due to meningioma risk
Cyproterone is an anti-androgen that, in the form of its acetate (cyproterone acetate), also has progestational properties. It is used in the treatment of hypersexuality in males, as a palliative in prostatic carcinoma, and, in combination with estrogen, for the therapy of severe acne and hirsutism in females. Following a review of the risk of…
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Safety alert: Levonorgestrel-Releasing Intrauterine Device and Panic Attacks
A safety signal raised for Levonorgestrel-Releasing Intrauterine Device. There are 602 reports for the MedDRA preferred term ‘panic attack’ associated with LNG-IUDs in VigiBase. Sixty-two percent of the cases were considered as serious. Levonorgestrel is a hormonal contraceptive progestin drug used in gynaecology for different indications. It can be used as a single substance or…
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Elagolix Reduces Heavy Menstrual Bleeding in Women with Uterine Fibroids
Women with uterine fibroids who used elagolix (Orilissa) with add-back therapy saw a reduction in heavy menstrual bleeding. A study was conducted in US and evaluated the safety and efficacy of elagolix at a dose of 300 mg 2 times a day with hormonal add-back therapy in women with bleeding due to fibroids. The lead…
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FDA Approves New Vaccine for Influenza A (H5N1)
The US Food and Drug Administration (FDA) has approved a novel vaccine to help protect patients as young as 6 months old against influenza A (H5N1), according to a press release from Seqirus. With approval, influenza A monovalent vaccine, adjuvanted (Audenz™) becomes the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A in…
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FDA approves 1st treatment for children with peanut allergies
Palforzia, a groundbreaking new drug, has just been approved by the Food and Drug Administration. The pill is meant for children who have severe reactions to peanuts and it works by helping to build tolerance to the nuts. Though it is not a cure but still marks a step forward in reducing allergic reactions for…
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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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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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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…