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Hypoglycemia a possible adverse reaction to linezolid
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The FDA has found that hypoglycemia may be an adverse effect associated with linezolid, according to a report in Clinical Infectious Diseases.
Patients with diabetes who receive insulin or oral hypoglycemic agents appear to be at the highest risk. The FDA updated the Warnings and Precautions section on the linezolid (Zyvox, Pfizer) insert to inform providers of this potential interaction, FDA investigators wrote in the report.
After reviewing a report of symptomatic hypoglycemia related to linezolid in a 64-year-old man with diabetes, FDA officials launched a broader inquiry. They searched the FDA Adverse Event Reporting System for incidents of hypoglycemia among people who received linezolid from April 2000 to March 2012.
They identified 41 reports of hypoglycemia among people who received linezolid, and excluded 26 that demonstrated no temporal association between the hypoglycemia and linezolid exposure. Among the remaining 15 studies, the link between hypoglycemia and linezolid was considered “highly probable” in seven cases, “probable” in four cases and “possible” in four cases.
Among the 15 cases, the median age was 77 years and 11 patients were male. Eight patients had received oral linezolid and six received IV linezolid. Information was not available for one patient. The median time to hypoglycemia after starting linezolid was 7 days. Overall, hypoglycemia resolved in ten patients after discontinuing linezolid and the outcomes for the other five are unknown.
Twelve of the patients (80%) had diabetes: nine were taking oral hypoglycemic drugs and two were taking insulin. Treatment information was not available for one patient. In eight of the patients, adjustment to the diabetes drug regimen did not resolve the hypoglycemia, but did resolve after linezolid was discontinued. There was no outcome data for the other four patients.
“Our review suggests that there is a potential relationship between linezolid use and hypoglycemia,” the investigators wrote. “Health care providers should be aware of this possibility when prescribing linezolid, especially in diabetic patients.”
Disclosure: The researchers report no relevant disclosures.
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