Monday, May 4, 2009

Botox : FDA instructs manufacturers to add boxed warning about possible negative effects

Botox has been used by doctors in recent years to help manage muscle spasticity. I've heard many success stories and some warnings about using Botox to treat spasticity. I don't have any personal experience with this use of Botox and our son's physiatrist has never mentioned that he would recommend it for our son. I've included links and quotes below from a few sources, including the FDA. Hopefully this FDA warning will help parents make informed decisions about their children's treatment.

Botox helps kids with CP
"...the drug forces the stronger contracting muscles to relax, a condition that lasts for a few months. During that time, physical therapists can work with the child to develop the weaker muscles that control extension. Although it's not appropriate for all children with CP, the treatment may help some move normally."

The Latest on Botox for Cerebral Palsy
"The FDA, which has never approved botulinim toxin for this use, issued instructions to manufacturers to add a boxed warning on labels about possible negative effects."

"Will these precautions make you less likely to seek this treatment for your child? Or have you had such success with it that you're willing to take the risk?"

Follow-up to the February 8, 2008, Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)
"As the result of an ongoing safety review, FDA has notified the manufacturers of licensed botulinum toxin products of the need to strengthen warnings in product labeling, and add a boxed warning, regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected."

"Botulinum toxin products have been approved by FDA for one or more of the following uses: temporary improvement in the appearance of glabellar lines (frown lines between the eyebrows), treatment of strabismus (crossed eyes), blepharospasm (abnormal tics and twitches of the eyelids), cervical dystonia (involuntary sustained or repetitive contraction of the neck muscles), and primary axillary hyperhidrosis (severe underarm sweating). For these uses, botulinum toxin is injected into the skin or into muscle tissue."

"In pediatric postmarketing adverse event case reports, botulinum toxin products were mostly used to treat muscle spasticity in cerebral palsy, a use that has not been approved by the FDA. The reported cases of spread of botulinum toxin effect beyond the site of injection were described as botulism, or involved symptoms including difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision, or respiratory depression. Serious case reports described hospitalizations involving ventilatory support and reports of death."

" professionals who use botulinum toxin products should understand that these adverse events have been reported as early as several hours and as late as several weeks after treatment."

Allergan to Resolve Botox Safety Labels
"Most deaths and serious problems were seen in children treated for cerebral palsy-associated limb spasticity, the FDA said."

Blues for Botox? 'Black box' warning, slumping economy, competitors may impact dominance
"Typically reserved for medications associated with serious or life-threatening risks, the "black box" warning is one of the strongest safety actions the agency takes. The FDA noted that problems with botulinum toxin had occurred mainly in patients receiving overdoses for unapproved therapeutic treatments, such as use in limb spasticity in children with cerebral palsy."

No comments:

Post a Comment