Many newspapers and TV news channels have been talking about the deaths of 18 people from injections of botox/myobloc. Possibly many of you have heard about them. We would just like to advise you of what has transpired. First of all, you will find in this letter a release by the FDA with a brief description of what has happened. The people who died from these injections were mainly juvenile cerebral palsy patients and botox/myobloc was not an approved FDA drug for this use. No one who has dystonia has been affected by any injections of botox/myobloc. We hope this puts your mind at ease.
Early Communication about an Ongoing Safety Review
Botox and Botox Cosmetic (Botulinum toxin Type A) and
Myobloc (Botulinum toxin Type B)
This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that 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.
FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected.
THE MOST SERIOUS CASES HAD OUTCOMES THAT INCLUDED HOSPITALIZATION AND DEATH, AND OCCURRED MOSTLY IN CHILDREN TREATED FOR CEREBRAL PALSY-ASSOCIATED LIMB SPASTICITY. USE OF BOTULINUM TOXINS FOR TREATMENT OF LIMB SPASTICITY (SEVERE ARM AND LEG MUSCLE SPASMS) IN CHILDREN OR ADULTS IS NOT AN APPROVED USE IN THE U.S.
These serious systemic adverse reactions occurred following treatment of a variety of conditions using a wide range of botulinum toxin doses. FDA is currently reviewing safety data from clinical studies submitted by the manufacturers of Botox, Botox Cosmetic and Myobloc, as well as post-marketing adverse event reports and the medical literature.
Botox (botulinum toxin type A) is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, also botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines.
Myobloc (botulinum toxin Type B) is approved for the treatment of adults with cervical dystonia; the safety and effectiveness of Myobloc for cervical dystonia in children have not been established...
