Another recall, this one on Zinbryta:
Friday, May 04, 2018
Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel
News of a recall of the product known as Limbrel. From the FDA:
Limbrel has been marketed since 2004 as a medical food available only by prescription for patients under active and ongoing supervision of a physician for the dietary management of osteoarthritis (OA), a degenerative disease of the joints and the most common form of arthritis. Prior to marketing, Primus conducted clinical studies that support the efficacy and safety of Limbrel and compiled an extensive dossier providing an analysis of published data to support the medical food status of Limbrel and to establish how the product meets the distinctive nutritional requirements of OA. Primus stands by the legal status of Limbrel as a medical food. Limbrel products have been distributed nationwide in the USA to wholesalers, pharmacies, and physicians as medical foods without challenge from FDA for over 13 years, with approximately 2 million prescriptions and physician samples dispensed to an estimated 450,000 patients.
Thursday, May 03, 2018
News across the web about Tasigna:
Subject: Updated information regarding the possible risk of developing atherosclerosis-related conditions with the use of TASIGNA* (nilotinib)
Novartis Pharmaceuticals Canada, Inc. (Novartis), in collaboration with Health Canada, would like to inform you about important safety information regarding reports of atherosclerosis-related conditions in patients treated with TASIGNA* (nilotinib).
TASIGNA* is a prescription medicine used to treat adult patients at different stages of a type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML).
- Cases of atherosclerosis-related conditions have been reported during clinical trials and post marketing experience with the use of TASIGNA*.
- Patients should tell their healthcare professional if they have or have had any conditions that could cause atherosclerosis-related conditions such as a heart problem, high blood pressure, high cholesterol, or high glucose before starting TASIGNA* treatment.
- During treatment with TASIGNA*, healthcare professionals will check for signs of atherosclerosis. Healthcare professional will also check cholesterol and blood sugar levels before starting treatment and periodically thereafter.
- Patients should not stop treatment with TASIGNA* or change the dosage without discussing their condition with their healthcare professional.
Atherosclerosis is a disease that occurs in arterial blood vessels (arteries) and occurs more frequently in older adults. In atherosclerosis the walls of the arteries become thickened and hardened by plaque buildup. Plaque is made from fatty deposits and cells that can build up in the walls of your arteries over many years. As plaque builds up, the arteries narrow and become less flexible and the blood flow through the arteries can be reduced. Possible complications of atherosclerosis include heart attacks and strokes.