Linezolid (Page 3 of 14)

5.8 Convulsions

Convulsions have been reported in patients when treated with linezolid. In some of these cases, a history of seizures or risk factors for seizures was reported.

5.9 Hypoglycemia

Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents when treated with linezolid, a reversible, nonselective MAO inhibitor. Some MAO inhibitors have been associated with hypoglycemic episodes in diabetic patients receiving insulin or hypoglycemic agents. While a causal relationship between linezolid and hypoglycemia has not been established, diabetic patients should be cautioned of potential hypoglycemic reactions when treated with linezolid.

If hypoglycemia occurs, a decrease in the dose of insulin or oral hypoglycemic agent, or discontinuation of oral hypoglycemic agent, insulin, or linezolid may be required.

5.10 Development of Drug-Resistant Bacteria

Prescribing linezolid in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

The safety of linezolid was evaluated in 2,046 adult patients enrolled in seven Phase 3 comparator-controlled clinical trials, who were treated for up to 28 days.

Of the patients treated for uncomplicated skin and skin structure infections (uSSSIs), 25.4% of linezolid-treated and 19.6% of comparator-treated patients experienced at least one drug-related adverse event. For all other indications, 20.4% of linezolid-treated and 14.3% of comparator-treated patients experienced at least one drug-related adverse event.

Table 2 shows the incidence of all-causality, treatment-emergent adverse reactions reported in at least 1% of adult patients in these trials by dose of linezolid.

Table 2. Incidence (%) of Treatment–Emergent Adverse Reactions Occurring in > 1% of Adult Patients Treated with Linezolid in Comparator-Controlled Clinical Trials
*
Comparators included cefpodoxime proxetil 200 mg by mouth every 12 hours; ceftriaxone 1 g intravenously every 12 hours; dicloxacillin 500 mg by mouth every 6 hours; oxacillin 2 g intravenously every 6 hours; vancomycin 1 g intravenously every 12 hours.

ADVERSE REACTIONS

Uncomplicated Skin and Skin Structure Infections

All Other Indications

Linezolid 400 mg by mouth every 12 hours

(n = 548)

Clarithromycin 250 mg by mouth every 12 hours

(n = 537)

Linezolid 600 mg every 12 hours

(n = 1,498)

All Other Comparators *

(n = 1,464)

Headache

8.8

8.4

5.7

4.4

Diarrhea

8.2

6.1

8.3

6.4

Nausea

5.1

4.5

6.6

4.6

Vomiting

2

1.5

4.3

2.3

Dizziness

2.6

3

1.8

1.5

Rash

1.1

1.1

2.3

2.6

Anemia

0.4

0

2.1

1.4

Taste alteration

1.8

2

1

0.3

Vaginal moniliasis

1.8

1.3

1.1

0.5

Oral moniliasis

0.5

0

1.7

1

Abnormal liver function tests

0.4

0.2

1.6

0.8

Fungal infection

1.5

0.2

0.3

0.2

Tongue discoloration

1.3

0

0.3

0

Localized abdominal pain

1.3

0.6

1.2

0.8

Generalized abdominal pain

0.9

0.4

1.2

1

Of the patients treated for uSSSIs, 3.5% of linezolid-treated and 2.4% of comparator-treated patients discontinued treatment due to drug-related adverse events. For all other indications, discontinuations due to drug-related adverse events occurred in 2.1% of linezolid-treated and 1.7% of comparator-treated patients. The most common reported drug-related adverse events leading to discontinuation of treatment were nausea, headache, diarrhea, and vomiting.

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