Please login to the form below

Not currently logged in
Email:
Password:

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

Share

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Jet Off with Maloff Protect

Latest intelligence

InSite Events™ National Pharma Meeting: A Customer Story
How our client leveraged Impetus Digital’s white-glove service, 360° coverage and care, and award-winning InSite Events™ platform to successfully transfer their annual national meeting online....
Fear or encouragement, which is best to drive behaviour change?
The communications industry depends on fear of the perceived loss of something, in order to create the hope found in a product benefit. But, if if left too long unchecked,...
The unheard, unseen, and uncorrected effects of COVID-19
The disproportionate effects of the pandemic have been highlighted amongst ethnic minorities, so is it likely that ethnic minorities will be more worried about participating? And could this exacerbate inequalities...

Infographics