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Increased risk of death linked with Tygacil

The US FDA has issued a safety warning to remind healthcare professionals of the increased mortality risk associated with antibacterial Tygacil

The US Food and Drug Administration (FDA) has issued a safety warning to remind healthcare professionals of the increased mortality risk associated with the use of Pfizer's intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections.

The increased risk was identified following the analysis of pooled data from multiple clinical trials. According to the FDA, most deaths in patients with these severe infections were related to progression of the infection.

The FDA has added information regarding increased mortality risk of Tygacil to the Warnings and Precautions and Adverse Reactions sections of the Tygacil drug label. The US authority has also issued "Dear healthcare professional" letters warning of the increased risk.

Tygacil is approved by FDA for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community acquired pneumonia.

However, the most common occurrences of increased risk were in patients treated for hospital-acquired pneumonia, particularly ventilator-associated pneumonia – for which Tygacil is not approved by the FDA.

The risk was also present in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. None of these conditions are approved by the FDA to be treated with Tygacil.

Healthcare professionals are being advised to use alternatives to Tygacil in patients with severe infections and to report any adverse events to the FDA MedWatch programme.

2nd September 2010

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