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FDA updates tacrolimus side effects and warnings

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Patients with elevated serum creatinine levels and tacrolimus blood levels above the recommended range may require a dose reduction or temporary discontinuation of tacrolimus. When using tacrolimus in combination with other nephrotoxic drugs, renal function and blood concentrations of tacrolimus should be monitored, and the dose of both drugs should be adjusted as needed.

Tacrolimus use has also been associated with thrombotic microangiopathy (TMA), including hemolytic uremic syndrome and thrombotic thrombocytopenic purpura. The development of TMA in transplant patients may be attributed to various risk factors such as severe infections, graft-versus-host disease, HLA mismatch, use of calcineurin inhibitors, and mTOR inhibitors. These risk factors may act independently or together to increase the likelihood of developing TMA.

Tacrolimus can be used for the treatment of atopic dermatitis in certain circumstances. Tacrolimus is an immunosuppressant medication that works by inhibiting the activation of T-cells in the immune system, which play a role in the inflammation that causes dermatitis.

Tacrolimus is typically reserved for use in patients with moderate to severe atopic dermatitis who have not responded adequately to other treatments, such as topical steroids. It is applied topically as an ointment or cream to affected areas of the skin.

It's worth noting that there have been concerns about a potential increased risk of skin cancer associated with the long-term use of tacrolimus ointment for atopic dermatitis, although current evidence suggests that this risk is low. Patients using tacrolimus for atopic dermatitis should be monitored by a healthcare provider and advised to practice sun protection measures.

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