[Fwd: [DBSforDystonia] FDA MedWatch - Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B): Boxed Warning required]

[Guest guest]

Dear friends,

I have spoken a few times on this list about our experiences with Botox

for my son's muscle disorder mirrored in some ways what I have seen

others here experience with Miralax. That the effects were terrible -

and the professionals were just not listening. Instead it seemed

like this was the greatest stuff since sliced bread and only we were

crazy enough to think it was harming our child.

When my son had his Botox problems - if you told me the day would come

in a few years that everything would be different and doctors would be

much, much more careful with Botox, I would probably not have believed

you. But that day has come. so take heart. :-) Keep fighting

ladies. Every month that passes you convince me more and more about

miralax (even though you had me convinced pretty quickly and because of

you all we never gave it for more than 2 weeks and only at low doses.)

It's a good day in our house - see below.

Sharry

FDA notified healthcare professionals

that after an ongoing

safety review initiated in February 2008, the manufacturers of

licensed

botulinum toxin products will be required by FDA 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.

FDA will also require that manufacturers develop and implement a Risk

Evaluation and Mitigation Strategy [REMS], including a communication

plan to

provide more information regarding the risk for distant spread of

botulinum

toxin effects after local injection, as well as information to explain

that

botulinum toxin products cannot be interchanged. The REMS would also

include a

Medication Guide that explains the risks to patients, their families,

and

caregivers. FDA is requiring the manufacturers to submit safety data

after

multiple administrations of the product in a specified number of

children and

adults with spasticity to assess the signal of serious risk regarding

distant

spread of toxin effects.

FDA's evaluation of the data continues to

support the recommendations made in the 2008 Early Communication.

Read the MedWatch safety summary, including a link to the Communication

about Botox, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#Botox

You are encouraged to report all serious adverse events and

product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm