Clinical

Articles

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. 

Safety Questions Follow Positive Results for Lecanemab in Alzheimer’s

Exela Pharma is recalling an additional 14 lots of sodium bicarbonate injection because of a broken vial.

Exela Pharma Expands Recall of Sodium Bicarbonate

Adderall pills containing methamphetamine and oxycodone pills containing fentanyl have been among the fake pills the DEA and investigators have confiscated.

Authorities Seize Fake Drugs with Lethal Doses of Meth and Fentanyl

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.

FDA Warns About Prolia in Patients with Kidney Disease

The FDA has issued a final guidance for beta-lactam oral antibiotic suspension products, including amoxicillin.

Compounding Pharmacies to Help Alleviate Amoxicillin Shortage

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.

Omnipod 5 Charging Ports are Subject to Overheating

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%.

Hospital Demand for Amoxicillin Increases While Shortage Continues

Omnipod DASH PDMs are at increased risk of malfunction if overcharged beyond the maximum battery voltage.

Battery Issues Affect Omnipod Dash Personal Diabetes Managers

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

The regulatory agency has added the risk of rare skin infections to the warnings and precautions section of the labeling for amoxicillin products.

FDA Calls Attention to Serious Skin Reactions of Amoxicillin

Several suppliers of the widely-used antibiotic have limited or no availability of some formulations.


Safety & Recalls