The Neurotoxin Advisory Council's response to the Public Citizen letter to the FDA regarding the safety of botulinum neurotoxins

The following is a response from members of the Neurotoxin Institute’s Advisory Council (NAC) to the recent letter from Public Citizen, a US consumer group, which was sent to the Food and Drug Administration. The letter called for increased serious adverse-event label warnings and the issuance of warning letters to physicians concerning the use of the botulinum neurotoxin formulations currently available in the US (type A [Botox] and type B [Myobloc])
(http://www.citizen.org/publications/release.cfm?ID=7559).

The Public Citizen request was based on a review of 658 reports of adverse events following injection of botulinum neurotoxin, 180 of which were associated with aspiration, dysphagia, pneumonia, or death (in 16 patients). Data for the review were obtained from the FDA adverse-event database, which is publicly available. The FDA has made an early response to this letter, which can be accessed through the following link:
http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm

Additionally, each of the pharmaceutical companies that manufacture and market these neurotoxins has issued responses which can be accessed via the following links:
http://agn360.client.shareholder.com/releasedetail.cfm?ReleaseID=290197
http://agn360.client.shareholder.com/releasedetail.cfm?ReleaseID=293012
http://www.solsticeneuro.com/news/solstice_PR_2.08.08.html

The American Academy for Cerebral Palsy and Developmental Medicine (AACPDM) posted their response to the FDA inquiry into adverse events with botulinum neurotoxins, which can be viewed on the following link:
http://www.aacpdm.org/index?service=page/fda_announcement

Members of the NAC would like to reiterate their support for the therapeutic use of botulinum neurotoxins based on physicians’ informed clinical judgment. Extensive clinical experience with these products has shown them to be effective and safe when used appropriately. As with any medication, there are potential associated side effects that must be weighed against the therapeutic benefit on a patient-by-patient basis. Botulinum neurotoxins have been widely studied and used for many years and the product labeling for each of the available formulations provides information on appropriate use and the potential for adverse events. Information supplied on this website (www.neurotoxininstitute.org) provides important scientific and clinical data that support the appropriate use of these agents.

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