petition

Petition to the FDA requesting a “Black Box” warning be issued for disabling central nervous system effects of fluoroquinolone antibiotics. Food and Drug Administration Department of Health and Human Services Petition to the U.S. Food and Drug Administration ( FDA), to take action concerning the long term disabling and sometimes permanent central nervous system disorders caused by fluoroquinolone antibiotics. The adverse central nervous system effects include but are not limited to: anxiety, depression, panic attacks, suicidal ideation, depersonalization, toxic psychosis, paranoia, tremors, vertigo, cognitive dysfunction, seizures and chronic insomnia. These adverse central nervous system effects often do not resolve after discontinuation of the drug. In many instances, these reactions appear many weeks after cessation of the antibiotic and worsen in the following months. Action Requested: In order to alert both physicians and patients, this petition requests the FDA to mandate that manufacturers of fluoroquinolone antibiotics adopt the following safety measures: Place a "Black Box" warning on the product label to reflect the potential severe long term central nervous system disorders associated with this class of antibiotics. We also request additional warnings in the form of a "Dear Health Care Provider" letter and a Medguide for patients. This information would help inform medical providers and the public about the potential long term disabling central nervous system effects of fluoroquinolone antibiotics. These significantly improved warnings to doctors and patients would increase the likelihood of earlier medical intervention when symptoms of central nervous adverse reactions first appear. Within the Medguide, a stronger warning needs to be issued for the combined use of a non-steroidal anti-inflammatory drug ( Nsaid ) with a fluoroquinolone. The current warning states that there may be an increased risk of central nervous system stimulation when these two medications are combined. This warning is inadequate. Bolded warnings highlighting this increased risk need to be issued. Approximately half of all of the fluoroquinolone antibiotics that were once on the market have now been removed from clinical practice due to significant toxicities. Physicians and patients are not being made aware of the potential devastating effects to the central nervous system from these commonly prescribed antibiotics. Fluoroquinolone antibiotics can induce a very wide range of long term neuro-toxic effects mentioned above. www.medicationsense.com/articles/jan_mar_04/congress_ltr.html We, the undersigned, request the FDA to enact the safety measures listed in this petition. Please click here to sign the petition now.