FDA Strengthens Warnings About Class of Antibiotics

The U.S. Food and Drug Administration it I strengthening label warnings on a class of antibiotics called fluoroquinolones because the drugs can lead to disabling side effects, including long-term nerve damage and ruptured tendons. The Agency also cautioned that these bacteria-fighting drugs — including levofloxacin (Levaquin) and ciprofloxacin (Cipro) — shouldn't be prescribed for sinusitis, chronic bronchitis or simple urinary tract infections unless no other treatments options exist. Besides Cipro and Levaquin, other fluoroquinolones include moxifloxacin (Avelox), ofloxacin (Floxin) and gemifloxacin (Factive). A safety review revealed that potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system can occur hours or weeks after exposure to fluoroquinolone pills or injections. Also, two or more serious side effects can occur together, the FDA said. Because of this, the FDA recommends reserving these antibiotics for serious bacterial infections, such as anthrax, plague and bacterial pneumonia. The new labeling action will include an updated boxed warning and revisions to the Warnings and Precautions section of the label. Also, a medication guide that patients receive describes the safety issues tied to these drugs, the agency said.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm513183.htm