Botulinum Toxin Safety Issues
The US Food and Drug
Administration (FDA) has issued an “Early Communication” regarding a safety
review of botulinum toxins types A and B for both FDA-approved and unapproved
(sometimes called “off label”) uses in the United States. This review includes
BOTOX® and
MYOBLOC®
The FDA is reviewing reports of serious side effects following the use of botulinum toxins, particularly for the management of juvenile cerebral palsy in which large doses of the medication are administered.
This posting of an “Early Communication” is a routine measure taken by the FDA to provide the public with early information regarding safety or other related reviews, often before any conclusions are or can be made.
The FDA made clear that “the posting of this information does not mean that there is a causal relationship between the botulinum toxins and adverse events. Nor does it mean that the FDA is advising healthcare professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.”
Mahlon R. DeLong, M.D. Scientific Director of the Dystonia Medical Research Foundation (DMRF) commented on the use of botulinum toxins as a treatment for dystonia:
“The administration of botulinum toxin for neurological disorders such as dystonia is safe and efficacious because of the small amounts used in therapy. Botulinum toxin has been used as a treatment for dystonia since 1980 and worldwide thousands of patients have been treated with very few adverse affects. If anyone has questions about their treatment plans, they are urged to consult with their physicians.”
The manufacturers of botulinum toxins are working very closely with the FDA to ensure that it has all of the information necessary, including safety data from clinical trials, to make an informed and reasonable judgment regarding them. The DMRF will share further information on this issue as it becomes available.
As a service to our members, it is the policy of the DMRF to report on developments regarding all types of dystonia but not to endorse or recommend treatment. We urge you to consult your own healthcare professional about your individual treatment plan.
The FDA is reviewing reports of serious side effects following the use of botulinum toxins, particularly for the management of juvenile cerebral palsy in which large doses of the medication are administered.
This posting of an “Early Communication” is a routine measure taken by the FDA to provide the public with early information regarding safety or other related reviews, often before any conclusions are or can be made.
The FDA made clear that “the posting of this information does not mean that there is a causal relationship between the botulinum toxins and adverse events. Nor does it mean that the FDA is advising healthcare professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.”
The DMRF supports the FDA’s efforts to ensure that treatments for all disorders, including dystonia, are safe and effective. We appreciate the manufacturers’ efforts to cooperate with the FDA, putting patient safety above all.
Mahlon R. DeLong, M.D. Scientific Director of the Dystonia Medical Research Foundation (DMRF) commented on the use of botulinum toxins as a treatment for dystonia:
“The administration of botulinum toxin for neurological disorders such as dystonia is safe and efficacious because of the small amounts used in therapy. Botulinum toxin has been used as a treatment for dystonia since 1980 and worldwide thousands of patients have been treated with very few adverse affects. If anyone has questions about their treatment plans, they are urged to consult with their physicians.”
The manufacturers of botulinum toxins are working very closely with the FDA to ensure that it has all of the information necessary, including safety data from clinical trials, to make an informed and reasonable judgment regarding them. The DMRF will share further information on this issue as it becomes available.
As a service to our members, it is the policy of the DMRF to report on developments regarding all types of dystonia but not to endorse or recommend treatment. We urge you to consult your own healthcare professional about your individual treatment plan.
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