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SAFETY NOTICE US

FDA places ceftazidime-avibactam (Avycaz) and aztreonam-avibactam (Emblaveo) on drug shortage list amid surge in carbapenem-resistant infections

FDA has added ceftazidime-avibactam (Avycaz; Pfizer) and the newly approved aztreonam-avibactam (Emblaveo; Pfizer/AstraZeneca) to the active drug shortage list following a significant increase in demand driven by rising carbapenem-resistant Enterobacterales (CRE) and Pseudomonas aeruginosa infections in hospital settings. FDA and ASHP are coordinating with manufacturers to accelerate supply restoration. Clinicians are advised to consult antimicrobial stewardship programmes before prescribing and to conserve supply for documented CRE infections.

Official notice ↗ ← All news

Which products are affected

Avycaz (ceftazidime-avibactam) ↗ (Pfizer) and Emblaveo (aztreonam-avibactam) ↗ (Pfizer/AstraZeneca) are both listed on the FDA Drug Shortages database ↗. Both are beta-lactam/beta-lactamase-inhibitor combination antibiotics active against carbapenem-resistant Gram-negative bacteria. Check the ASHP drug shortage database ↗ for current supply status, lot availability, and alternative sourcing information.

Why the shortage matters: rising CRE rates

Carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA) are CDC urgent antimicrobial resistance threats ↗. CRE infections carry mortality rates of 40–50% in bloodstream infections. Ceftazidime-avibactam is a first-line option for KPC-producing CRE per IDSA AMR guidance ↗; aztreonam-avibactam extends coverage to metallo-β-lactamase (MBL) producers including NDM. Shortages of these agents leave clinicians with severely limited alternatives for the most resistant pathogens. See our antibiotic stewardship guide for prescribing frameworks.

Stewardship and conservation strategies

During shortages, ASHP shortage management guidelines ↗ recommend: (1) restricting avibactam-containing antibiotics to microbiologically confirmed CRE with susceptibility testing; (2) consulting infectious disease pharmacy specialists before use; (3) exploring ceftolozane-tazobactam for CRPA (PubMed) ↗ as an alternative where susceptible; (4) contacting manufacturers directly for compassionate supply. Antimicrobial stewardship programmes are pivotal — see CDC Core Elements of Hospital Antibiotic Stewardship ↗.

Prescribing information and adverse effect monitoring

Prescribing information for Avycaz and Emblaveo is available on DailyMed ↗. Both require renal dose adjustment (eGFR-based). Ceftazidime-avibactam has a notable interaction with CYP450-neutral profile but requires monitoring for CNS toxicity (seizures) at high doses in renal impairment. Aztreonam-avibactam has cross-reactivity considerations with penicillin allergy — the aztreonam side-chain shares structure with ceftazidime. Report adverse events to FDA MedWatch ↗.

FAQ

Does a Boxed Warning mean a drug is being withdrawn?

No. A Boxed Warning ↗ (also called a Black Box Warning) is the FDA's strongest label caution, but the drug remains on the market. It means the agency has determined that a risk is serious enough to require prominent, standardised labelling. The drug continues to be prescribed under appropriate clinical conditions. See the FDA's patient guide to Boxed Warnings ↗.

Where can I read the full updated label?

All current FDA-approved prescribing information is available on DailyMed ↗, maintained by the National Library of Medicine (NLM). Search by drug name to find the most recent label version. Historical label versions are also archived there.