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Press Release by FLUOROQUINOLONE TOXICITY RESEARCH FOUNDATION in Volunteer
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Ciprofloxacin Approved for Pediatric Use, an RX for Disaster
Plant City Florida
View all releases by FLUOROQUINOLONE TOXICITY RESEARCH FOUNDATION
This press release is about: ciprofloxacin, pediatric, population, approved, such, permanent, drugs, use, chemotherapeutic, disaster, patients
2004-06-03, FLUOROQUINOLONE TOXICITY RESEARCH FOUNDATION - Ciprofloxacin Approved for Pediatric Use, an RX for Disaster Plant City Florida The recent approval of Ciprofloxacin for use in the pediatric population may result in permanent joint damage and even fatal adverse reactions. The FDA being fully advised regarding such events has approved such useage anyhow.(PRWEB) June 14, 2004 -- In spite of the overwhelming evidence presented at that 62 Meeting of the Anti-Infective Drugs Advisory Committee that the fluoroquinolones cause irreversible joint damage in the pediatric population the FDA has recently added the use of Ciprofloxacin in the pediatric population, treating children as young as one years of age. Numerous studies have indicated that such use in a pediatric patient runs the risk of crippling the child for life. Yet additional clinical trials continue aided and abetted by the FDA, for other drugs in this class other than Ciprofloxacin. A disaster that is detailed within the 62nd meeting of the Anti-Infective Drugs Advisory Committee where overwhelming evidence was presented detailing such damage. In spite of the following horrendous side effects presented at this meeting this committee stated “…We clearly want to encourage development of these drugs for use in pediatrics…”. Permanent disability Permanent lameness Joint effusion Joint pain Latent articular disease or damage that may occur months or years following drug exposure Lesions that don`t appear to be reversible Potential for a delayed effect that would not be manifest clinically for many years Damage in the chondrocytes Eight deaths (five of which involved Ciprofloxacin) 14 reports of arthropathy Seizures Stunted growth Suicide attempts Hallucinations Photosensitivity Knee effusions persisting one year later with destructive arthropathy of the knees and the hip (And with regards to muscular-skeletal events, 21 percent of the patients had an event in Ciprofloxacin) Within the newest package insert for Ciprofloxacin we find peripheral neuropathy being added as a severe, non-abating adverse drug reaction. Of additional concern is the fact the there are also ongoing clinical trials regarding the use of other chemotherapeutic agents within this class involving pediatric patients as young as six months of age. For more than forty years since the introduction of Nalidixic Acid in 1962, severe and permanent injury to the patient has been documented. Now the FDA has given they’re blessing on the use of chemotherapeutic agents within the pediatric population. The use of these drugs will NOT be restricted to the approved indications either. The FDA has stated “…obviously, the issue of off label use will extend over to pediatric populations …” So now a child with a minor ear ache or sore throat will risk being crippled for the rest of their lives and the FDA will continue to turn a blind eye to such abuse for it is NOT within the legal rights of the FDA to control how such drugs are used once they have been approved. As such we now look forward to a whole generation of pediatric patients being destroyed by the careless manner in which such drugs are utilized and the treating physician will continue to fail to recognize, treat and report such events. Numerous forums now exist on the Internet in which the adult patients have been reporting such severe reactions since 1999. We can all now look forward to the distraught parents of these children joining such forums as a direct result of this total and complete failure of the FDA to protect the health and welfare of the pediatric population.
Source: PR Web™
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