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| |  FDA Panel Recommends Approval Of Cipro For Treating Anthrax Exposure WEST HAVEN, CT -- July 31, 2000 -- A U.S. Food and Drug Administration (FDA) advisory panel today unanimously recommended the antibiotic Cipro® (ciprofloxacin) be approved for use in treating people exposed to aerosolized anthrax bacteria. This exposure would most likely occur during a bioterrorism attack. The FDA's Anti-Infective Drug Products Advisory Committee made the recommendation after reviewing data presented by Bayer Corporation (the manufacturer of Cipro), the FDA, and an investigator from the Department of Defense. The Agency is not bound by the decisions of its advisory panels, but usually follows them. "This is a very important public health issue and we are pleased with the panel's recommendation," said Lawrence Posner, MD, Global Head of Regulatory Affairs for Bayer. "While we hope there is never a need for such a use, we recognize the government must be prepared and we are confident that Cipro can play an important role in the preparedness plan." Without treatment, anthrax infection, caused by the bacterium Bacillus anthracis, is usually fatal. Although penicillin and doxycycline are approved to treat anthrax, there are reports that strains of the bacteria have been engineered to resist these antibiotics. Therefore, early antibiotic treatment with ciprofloxacin or other fluoroquinolone therapy has been recommended by The Working Group on Civilian Biodefense(1). The safety and efficacy data submitted for Cipro in treating anthrax exposure was based on an animal study conducted by the Department of Defense. After extensive discussions with the U.S. Department of Defense, the U.S. Centers for Disease Control and Prevention, and the FDA, Bayer filed the sNDA in February of this year. Cipro is already approved for 17 different indications including respiratory and urinary tract infections. Since its introduction in 1987, Cipro has been the most widely studied and used fluoroquinolone antibiotic in the world. It has a proven track record of efficacy and safety, and has been prescribed more than 250 million times. Cipro Tablets, Cipro Oral Suspension, and Cipro IV are indicated for the treatment of infections caused by susceptible strains of indicated organisms in the following conditions: acute sinusitis; lower respiratory tract infections; nosocomial pneumonia (I.V. only); urinary tract infections; acute uncomplicated cystitis in females (Tablets and Oral Suspension only); chronic bacterial prostatitis; complicated intra-abdominal infections (in combination with metronidazole); skin and skin structure infections; bone and joint infections; and infectious diarrhea, typhoid fever (enteric fever) and uncomplicated cervical and urethral gonorrhea (Tablets and Oral Suspension only). Cipro I.V. is also indicated in empirical therapy for febrile neutropenic patients (in combination with piperacillin sodium). Serious and fatal reactions have been reported in patients receiving concurrent administration of ciprofloxacin and theophylline. Monitor theophylline levels if concurrent administration cannot be avoided. The safety and effectiveness of ciprofloxacin in children, adolescents less than 18 years of age, pregnant women and lactating women have not been established. Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin or any member of the quinolone class of antimicrobial agents. Ciprofloxacin should be discontinued at the first sign of an allergic reaction. Most frequently reported adverse events (>1 percent) without regard to drug relationship were: Cipro Tablets and Oral Suspension: nausea, diarrhea, vomiting, abdominal pain/discomfort, headache, rash, restlessness. Cipro I.V.: nausea, diarrhea, CNS disturbance, local I.V. site reactions, abnormalities of hepatic enzymes, eosinophilia, headache, rash, restlessness. Antacids containing magnesium, aluminum or calcium, or other products containing metal cations should be taken two hours after or six hours before oral administration of Cipro. Reference: Related Link: Cipro (ciprofloxacin).
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