No pharmacovigilance signal of intracranial hypertension associated with glycylcyclines: a FAERS-based disproportionality analysis.

BACKGROUND AND

OBJECTIVE

Benign intracranial hypertension, i.e. increased intracranial pressure, is a well-known rare adverse effect of tetracyclines, but its association with glycylcyclines (tetracycline-like antibiotics) was not confirmed. To investigate whether there are signals in an adverse events database for increased intracranial pressure after using tigecycline and eravacycline, and to compare it with probably existing signals for tetracyclines.

METHODS

This secondary research was based on the FDA Adverse Event Reporting System (FAERS) Database. Disproportionality analysis was conducted and the following disproportionality indices were calculated: reporting odds ratios (ROR), Yule's Q, proportional reporting ratio (PRR) and the information component (IC) for 'intracranial pressure increased' and 'pseudotumor cerebri' adverse events.

RESULTS

Significant signals for adverse event 'intracranial pressure increased' were found for doxycycline (ROR ± 95%CI = 27.19 ± 4.95), tetracycline (ROR ± 95%CI = 79.29 ± 24.64) and minocycline (ROR ± 95%CI = 59.53 ± 16.39). Signals for omadacycline and sarecycline were not found, primarily due to the small number of reports. In the database, there were no reports of increased intracranial pressure, pseudotumor cerebri or intracranial hypertension for both tigecycline and eravacycline.

CONCLUSIONS

Although structurally related to tetracyclines, glycylcyclines are not associated with increased intracranial pressure based on current pharmacovigilance data. This may warrant re-evaluation of SmPC warnings and supports safer use in patients with suspected intracranial hypertension when no better alternatives are available.