sparfloxacin (ZAGAM)

Stronger Warnings for the Fluoroquinolone Antibiotic Gatifloxacin (TEQUIN)
May 2003
Stronger warnings have been added to the professional product label, or “package insert,” for the fluoroquinolone antibiotic gatifloxacin (TEQUIN) about possible heart rhythm disturbances and problems with blood sugar control. This drug was approved by the Food and Drug Administration (FDA) in October 2001 and its marketing brought to nine the number of fluoroquinolone antibiotics on the market.

New Research Results on Safety of Newly Approved Drugs Causes Health Research Group to Extend Five-Year Waiting Rule to Seven Years
June 2002
A study published in the May 1, 2002 Journal of the American Medical Association (JAMA) has resulted in a major change in the Health Research Group’s drug safety policy. The study, in association with physicians from the Harvard Medical School, examined the frequency and timing of the identification of new adverse drug reactions resulting in the addition of a black box warning in the drug’s professional product labeling or its outright removal from the market. You should wait at least seven years from the date of release to take any new drug unless it is one of those rare “therapeutic advances” that offers you a documented therapeutic advantage over older, proven drugs.