On February 8, 2008, the US Food and Drug Administration issued a safety alert regarding the use of Botox injections for neurological injuries. Prior to this date, the FDA had received reports for patients who have had severe respiratory side effects following the use of botulinum toxins type A and B. These reactions are believed to occur when the botulinum toxins spread in the body beyond the site where it is injected. The most serious cases associated with these injections resulted in hospitalization and even death in children treated for cerebral palsy associated limb difficulties. It is also worthwhile to note that this injection treatment has not been approved by the US Food and Drug Administration for children or adults.
Although not approved, doctors have recently experimented with using botox injections in patients with neurological injuries. In this treatment, doctors inject small amounts of Botox into areas of the neck which purportedly relieves pain for up to 120 days before it wears off. Unfortunately, because the technique and treatment is poorly understood, some patients have had muscle paralysis to the esophagus. As a result, these patients are unable to swallow, nor function properly as fluid and food is aspirated into the lungs. Tragically, as of February, 16 deaths have occurred and 658 reports of injuries have been associated with Botox injections.
And while Botox is receiving a lot of negative attention in the United States, Europe continues to permit Botox to be used for this treatment. However, the Europeans require a specific warning before use that the treatment can result in long-standing muscle weakness or paralysis–especially among children.
Fortunately, The FDA continues to monitor and study this issue. However, for those who have suffered an adverse event related to Botox, I highly recommend that they complete the form online posted on the FDA”s website.
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