DRUG INFORMATION HIGHLIGHTS

• Amylyx, the manufacturer of sodium phenylbutyrate and taurursodiol oral suspension (Relyvrio), has initiated the process with the FDA to voluntarily discontinue marketing authorization of Relyvrio in the U.S. based on results from the phase 3 PHOENIX study. Relyvrio was indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults. As of April 4, 2024, Relyvrio is no longer available for new patients; however, patients currently receiving the medication who, in consultation with their HCP, would like to continue therapy, are eligible to be transitioned to a free drug program.
• Avkare has voluntarily recalled one lot of atovaquone oral suspension, USP 750 mg/5 mL to the consumer level due to the potential for Bacillus cereus contamination. Microbial contamination was identified during stability testing and could lead to disseminated, life-threatening infections, such as endocarditis or necrotizing soft tissue infections, in immunocompromised patients.
• Amneal has voluntarily recalled four lots of vancomycin HCl for oral solution, USP, 250 mg/5 mL to the consumer level as some bottles may have been overfilled, which can result in an excess dose. Based on the maximum daily dose of 2 g/day, patients with a dosing regimen of 500 mg/10 mL would exceed the daily maximum dose, which could be harmful in those with renal insufficiency. The four recalled lots are packaged in 80 mL, 150 mL, or 300 mL sizes.
• Pfizer has announced discontinuation of manufacturing of linezolid (Zyvox) 600 mg tablet. The oral suspension formulation of Zyvox remains commercially available.
• Eli Lilly has announced discontinuation of the 3 mL vial of insulin lispro (Humalog). The 10 mL vials and KwikPen presentations of Humalog and insulin lispro injection remain available.
• The FDA has reported that Genentech will be discontinuing distribution of somatropin (Nutropin AQ) injection 5 mg/2 mL, 10 mg/2 mL, and 20 mg/2 mL. This is a business decision based on the availability of generic and alternative treatments.

DRUG INFORMATION HAPPENINGS

• The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded that current evidence does not demonstrate a causal association between GLP-1 agonists and suicidal thoughts or actions. However, manufacturers of GLP-1 agonists will monitor for these safety signals and report any new evidence.
• The American Society of Clinical Oncology (ASCO) has published a guideline update on systemic therapy for advanced hepatocellular carcinoma. The evidence-based guideline provides an update to the 2020 version and includes data from 10 new randomized controlled trials.
• The American Society of Health-System Pharmacists (ASHP) has published a summary of national drug shortage statistics from January 2001 to March 2024. Since data tracking began in 2001, current and ongoing shortages are the highest number reported on record at 323 drug shortages.
• The Centers for Disease Control and Prevention (CDC) is investigating Botox products that have led to harmful reactions. As of mid-April, 19 people in nine states have experienced these reactions following receipt of counterfeit product or injections administered by unlicensed individuals and/or administered in a non-health care setting (e.g., spas, homes); nine of these individuals were hospitalized and four of them were treated with botulism antitoxin due to symptoms consistent with toxin spread.

The content in this publication is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your health care provider.

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