The FDA's Drugs@FDA database records a supplement, dated 23 October, to Pfizer's application for linezolid (Zyvox). The record gives no detail of what the supplement changes.
Supplements cover a wide range of changes, from manufacturing and labelling text to new safety information, and most are administrative. Nothing in the listing indicates a new indication or a new safety warning.
Linezolid remains a reserve agent for resistant Gram-positive infections and a component of drug-resistant tuberculosis regimens. Its established toxicities are unchanged by this listing: myelosuppression with longer courses, peripheral and optic neuropathy, lactic acidosis and serotonin toxicity with serotonergic drugs.
- Check the current label for any change when the updated Zyvox labelling is published.
- Monitor full blood count weekly on linezolid courses longer than two weeks.
- Review serotonergic co-medication before starting linezolid.
- Ask about visual and sensory symptoms on prolonged courses, including in drug-resistant TB regimens.
Why it matters
A listing without detail is easily mistaken for a new warning or indication.
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