Research News
There recently has been increasing concern about the recent ? FDA and Black Box warnings regarding Botulinum Toxins Type A and B ( Botox and MyoBloc ). We have received many emails concerning the use of both Toxins and related reports that have been released by the group Public Citizens at www.citizens.org.
Please note the following information we received from Allergan, Inc. :
“The FDA announced on Friday ( 2-7-08)� in an “Early Communication” that it was reviewing certain serious adverse events following the use of botulinum toxins.� The FDA inquiry relates primarily to high dose medical uses of Botox, particularly for the management of juvenile cerebral palsy (see attached our press release� at www.allergan.com ).� As many people are not aware, Botox is indicated and used worldwide to treat a variety of often serious medical conditions. � Regarding any serious adverse events reported following the use of Botox therapeutic, it is important to note that in its more than 18-year history since the product was first approved worldwide, reports of serious adverse events following BotoxThe posting of an “Early Communication” by the FDA on Friday (2-7-08 )� is merely a routine protocol used by the Agency to provide early information regarding safety or other related reviews, often before any conclusions are or can be made.� Specifically, the FDA made clear in its communication that “the posting of this information does not mean that there is a causal relationship between the products and the adverse events.”Importantly, the FDA hosted a public teleconference� last week� in which it provided helpful clarification and context, explaining that this review involves only “a relative handful of serious adverse events” and that the primary focus of the adverse events and the FDA’s review of them related to the therapeutic use of BOTOX to treat juvenile cerebral palsy and other large muscle, lower limb spasticities.� While Botox is approved in about 60 countries to treat juvenile cerebral palsy, it is not approved for this use in the
The treatment of juvenile cerebral palsy involves very compromised, sick children and it also involves relatively large doses of product (often up to a total of 700 units).� In some of these adverse event reports, the physician had used doses that were much higher than the approved label for juvenile cerebral palsy in those countries that have approved its use.� � � �
As the FDA’s own press release on the topic notes, these adverse event reports do not indicate any problem with a batch of Botox but rather may relate to overdosing by the physician.� Our analysis indicates that when a problem arises in the use of the product for juvenile cerebral palsy, it tends to either be because the patient was already very high risk and sick and/or because a significant amount of Botox was administered.� �
While not approved in the United States, we know that physicians specialized in neurological and neuromuscular disorders have been using Botox for the treatment of juvenile cerebral palsy /spasticity with great success for more than a decade at their own medical discretion; and most physicians who use Botox in this way are well aware of the risk/benefit profile in this population and use it after making an informed medical judgment that the treatment is appropriate.
Furthermore, the product labeling for BOTOX already notes rare select cases of fatal outcomes in which some patients had significant debilitating conditions or may have had a history of cardiovascular disease or other co-morbid conditions. And the BOTOX labels specifically warn that patients with pre-existing neuromuscular disorders may be at increased risk of clinically significant systemic effects from typical doses of BOTOX.� Allergan will discuss with the U.S. FDA whether further clarify about the definition of juvenile cerebral palsy as a “neuromuscular” disorder is needed in the U.S. Botox label, and make any appropriate changes, as needed, following the Agency’s conclusion. ” ~ Corporate Communications, Allergan, Inc.
Further Information :
Allergan, Inc. Responds to Public Citizen’s Allegation Regarding a Fatality Following BOTOX(R) Cosmetic Treatment� �
http://agn360.client.shareholder.com/releasedetail.cfm?ReleaseID=290197
http://agn360.client.shareholder.com/releasedetail.cfm?ReleaseID=290726
http://agn360.client.shareholder.com/releasedetail.cfm?ReleaseID=293012
http://www.solsticeneuro.com/news/Solstice_PR_2.08.08.html� regarding MyoBloc.�
Finally, it is equally as important to explain that a report of an adverse event following treatment with a drug does not by itself mean that the drug caused the event, just that the event occurred after treatment with the drug.� So, for instance, if Allergan is notified of an adverse event following Botox treatment from any source, it is required to make an “adverse event report” to the appropriate health authorities even if Allergan or the physician has not established that Botox caused the event and, indeed, even if the treating physician has affirmatively concluded that Botox was not the cause of the event. ~ J.E.� The above is required of any pharmaceutical company. Thus, Rest Assured, Remain Assured, Be Assured.
http://care4dystonia.org/index.php/2008/02/13/cd-and-beb-merz-trials/� Name of this Post.