FDA approves new antibiotic - good news in fight against drug-resistant bugs

WASHINGTON (CP) - The U.S. government approved a new antibiotic Thursday to give hospitals another weapon against tough-to-treat infections.

Tygacil, known chemically as tigecycline, is an intravenous antibiotic, for use in treating complicated abdominal and skin infections in adults.

New antibiotics are urgently needed because bacteria are evolving to resist the effects of commonly used medications.

Tygacil is not approved in Canada, said a spokesman for Health Canada, which does not disclose whether a new drug has been submitted for regulatory review.

The medication is the first in a new class of antibiotics, derived from the older tetracycline family, said Dr. Edward Cox of the Food and Drug Administration.

It is a broad-spectrum antibiotic, meaning it can fight a range of bacteria, including the worrisome germ called methicillin-resistant staph aureus, or MRSA. Once spread mostly in hospitals, this hard-to-treat bacterium now is increasingly spread in the community as well, such as between athletes.

"Certainly having additional therapeutic options available is beneficial," Cox said.

Manufacturer Wyeth Pharmaceuticals said Tygacil can be used as first-line therapy, and in studies has proved comparable to some two-drug combination treatments now in use.

The most common side-effects are nausea and vomiting. But Cox said Tygacil comes with additional warnings similar to tetracyclines: it's not for use in pregnant women and may discolour teeth if given to young children.

Wyeth said it should be administered with caution to patients allergic to tetracyclines.