Category Archives: Antibiotics

New Drug Approvals Fall in 2010 as Safety Concerns Slow U.S. FDA Decisions – Bloomberg

Having a good pipeline of new drugs in essential to keep medical progress going forward. This is especially true for infectious diseases as bacteria continually evolve the ability to resist current drugs. Unfortunately new antibiotic development is on the back burner for many drug companies, as it is seen as being to expensive to develop.

New Drug Approvals Fall in 2010 as Safety Concerns Slow U.S. FDA Decisions – Bloomberg.

Drug Safety and Availability > FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections

Drug Safety and Availability > FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections.

A must read notice published by the FDA. It appears that there is a trend towards statistical inferiority of tigecycline when compared to standard therapy with regards to ventilator associated pneumonia. It is also notable that it did not show better outcomes in any category when compared to standard therapy.

This by no means indicates that tigecycline is an inferior drug but merely that it is about as good as other standard therapy on the market. Yes; it is a broader coverage drug similar to imipenem. But contrary to popular belief among my fellow colleagues, broader coverage drug not always equate with better drug or even a better outcome.

Keeping the coverage appropriate to the condition being treated using a drug that achieves appropriate serum levels at the site of the infection under the conditions currently present (pH, low O2 concentrations, neutropenia) will achieve optimal results.