Phenytoin and fosphenytoin linked to Stevens Johnson syndrome and toxic epidermal necrolysis
From the FDA website: FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across […]
Myths and facts about generic drugs: FDA presentation
Source: FDA Consumer Education: Generic Drugs
Questions and answers from the EMEA about the withdrawal of Ionysis
Transcription from the EMEA website of the questions and answers document on the recommendation to suspend the marketing authorisation of Ionsys What is Ionsys? Ionsys is a system that delivers the active substance fentanyl hydrochloride into the body through the skin. Fentanyl is an opioid analgesic (a strong painkiller that is related to morphine). Ionsys should only be […]
Atrial fibrillation and bisphosphonates: FDA Medwatch update
FDA issued an update to the Agency’s review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D) Etidronate (Didronel) Ibandronate (Boniva) Pamidronate (Aredia) Risedronate (Actonel, Actonel W/Calcium) Tiludronate (Skelid) Zoledronic acid (Reclast, Zometa) Bisphosphonates are a class of […]
Varenicline psychiatric side effects: recommendations from the MHRA
The Medicines and Healthcare products Regulatory Agency has issued recommendations about the use of varenicline (Champix) as a smoking cessation drug. Advice for healthcare professionals: • Patients and their family or care-givers should be made aware of the possibility that trying to stop smoking might cause symptoms of depression • Patients who are taking varenicline […]