Among the top safety stories this year are Genentech’s warning to Ocrevus label, FDA’s update to GnRH agonists, a study about JAK-inhibitor side effects, FDA’s warning about Prolia in kidney disease and safety issues related to the potential Alzheimer’s disease drug lecanemab.
Testing of the blood pressure medication revealed nitrosamine levels that were above acceptable limits.
Lilly’s first-in-class medicine that activates both the GLP-1 and GIP receptors, Mounjaro, is the latest to be included on the FDA’s drug shortages list because of high demand.
Lecanemab is an investigational anti-amyloid beta antibody to treat mild cognitive impairment due to Alzheimer’s disease. It is currently under review by the FDA and a decision is expected by Jan. 6.
Exela Pharma is recalling an additional 14 lots of sodium bicarbonate injection because of a broken vial.
Adderall pills containing methamphetamine and oxycodone pills containing fentanyl have been among the fake pills the DEA and investigators have confiscated.
An FDA review has found that Prolia can result in low calcium levels in the blood in patients with advanced kidney disease and can lead to hospitalization and death.
The FDA has issued a final guidance for beta-lactam oral antibiotic suspension products, including amoxicillin.
This is second issue related to Omnipod. Last week, the company announced that it had received 50 complaints related to the batteries of Omnipod DASH Personal Diabetes Manager.
Vizient saw a 43% surge in demand for all amoxicillin products in the acute care setting from September to October, but fill rates have dropped 25%.
Omnipod DASH PDMs are at increased risk of malfunction if overcharged beyond the maximum battery voltage.
The regulatory agency has added the risk of rare skin infections to the warnings and precautions section of the labeling for amoxicillin products.
Several suppliers of the widely-used antibiotic have limited or no availability of some formulations.
Findings by researchers at Epic, the electronic health record company, show that the benefits extend to people ages 50-64.
Administration of a solution containing glass could lead to irritation or swelling, vasculitis/phlebitis, allergic reactions, and pulmonary embolism.
The recall was triggered by the presence of nitrosamine above the proposed limit.
Two reports show that drug-related deaths are skyrocketing among people 65 years and older.
Exela has received five reports of flying glass injuring skin, eye and/or other parts. The recall includes both Exela and Civica brands.
Until supply is restored, the FDA suggests the use of alternatives such as the extended-release version of amphetamine mixed salts.
In one lot, a bottle containing clopidogrel was mislabeled as atenolol. This lot was sold to AmerisourceBergen and McKesson.
Dark red, brown and black particulates were seen inside of one vial. Acyclovir is used to treat genital herpes and shingles.
Although Xeljanz, Olumiant and Rinvoq are in the same drug class, the risk of serious adverse events from these three products to treat rheumatoid arthritis and other inflammatory conditions may not be similar.
Labor shortages and Drug Enforcement Agency quotas have led to supply shortages of Adderall and its generics, which are used to treat attention deficit hyperactivity disorder.
This recall of propofol because of particulates seen in vials follows a previous one in July 2022.
Genentech has updated the warnings section of the label for the MS therapy Ocrevus to include information about cases of immune-mediated colitis and a serious brain infection in the post-marketing setting.
