From the FDA Drug Label
Severe Renal Impairment Avoid use in patients with severe renal impairment, GFR <30 mL/minute. Increased plasma concentration of duloxetine delayed-release capsules, and especially of its metabolites, occurred in patients with end-stage renal disease (requiring dialysis)
- Duloxetine use is avoided in patients with severe renal impairment (GFR <30 mL/minute) due to increased plasma concentration of the drug and its metabolites in patients with end-stage renal disease.
- The FDA drug label does not directly state that duloxetine causes Acute Kidney Injury (AKI), but it does advise against use in patients with severe renal impairment.
- Caution is advised when using duloxetine in patients with conditions that may affect renal function 1.
- The label also mentions that population PK analyses suggest that mild to moderate degrees of renal impairment have no significant effect on duloxetine apparent clearance 1.
From the Research
Duloxetine can potentially cause acute kidney injury (AKI), though this is considered an uncommon side effect. According to the most recent study 2, drug-induced acute kidney injury is a significant cause of AKI, and patients taking duloxetine should be aware of the warning signs of AKI. The mechanism of duloxetine-related kidney problems may be related to drug-induced interstitial nephritis, hemodynamic changes, or direct tubular toxicity. Risk factors that may increase the likelihood of duloxetine-related kidney problems include pre-existing kidney disease, advanced age, dehydration, and concurrent use of other medications that affect kidney function, such as NSAIDs, diuretics, or ACE inhibitors.
Some key points to consider when prescribing duloxetine to patients with kidney impairment include:
- Dose adjustments may be necessary for patients with severe renal impairment (creatinine clearance <30 mL/min) 3
- Regular monitoring of kidney function is advisable when starting or adjusting duloxetine therapy, especially in patients with pre-existing kidney disease 4
- Patients taking duloxetine should be aware of the warning signs of AKI, including decreased urine output, fluid retention, shortness of breath, fatigue, confusion, nausea, or chest pain, and seek medical attention promptly if these symptoms develop.
It is essential to weigh the benefits and risks of duloxetine therapy in patients with kidney impairment and to consider alternative treatments if necessary. Additionally, patients with kidney impairment should be closely monitored for signs of AKI, and duloxetine should be used with caution in these patients. The most recent study 2 highlights the importance of recognizing drug-induced AKI early to enable dose reduction or drug suspension, depending on the type of reaction, to reduce healthcare costs and improve clinical outcomes for patients.