The FDA's drug approvals database recorded a supplement to Pfizer's new drug application for linezolid (Zyvox, NDA 021130) on 23 October. The harvested record does not state what the supplement covers: supplements can be labelling updates, manufacturing changes or new safety wording, and many are administrative.
No new indication or safety communication is described in the record, and nothing here should change prescribing. It is a prompt to check the current label if you prescribe linezolid often, since safety wording on this drug has been updated before.
Linezolid is widely used in India for MRSA, VRE and drug-resistant tuberculosis, mainly as generics; CDSCO has made no related statement that we are aware of.
- The content of this supplement is not specified in the FDA record; treat it as administrative until the label text is seen.
- Monitor full blood count weekly in patients on linezolid for more than about two weeks; myelosuppression is dose- and duration-related.
- Check for serotonergic drugs before starting linezolid; it is a weak monoamine oxidase inhibitor.
- Ask about visual symptoms and numbness in long courses, as in drug-resistant tuberculosis, because of optic and peripheral neuropathy.
Why it matters
Linezolid's harms grow with course length, and its use for resistant infections in India means long courses are common.
Don't overread it
A labelling supplement is not a new indication or a new safety warning.
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