May 1, 2009 (Wow May already!) Early in 2008 Botox was associated with serious respiratory side effects and even death. Therefore, the FDA is revising the safety warnings and requiring a “Risk Evaluation and Mitigation Strategy” or REMS on the packaging.The drug is used for a variety of conditions including cosmetic enhancement, treatment of blepharospasm and severe dystonia. It is also used for off-label conditions such as spasticity in cerebral palsy, chronic Migraine, and MS. Dosages vary with larger doses for dystonia and spasticity. Read the whole story.
This is all well and good. However, how many patients know that there are severe side effects? How many of us have even SEEN the package insert? I may be naive, but I didn’t see it nor did I think to ask.
The upside is that Allergan is seeking FDA approval for using Botoxfor chronic migraine. Nothing really will have changed, but I guess there is some comfort knowing that Botox is an approved drug for migraine.
Older news:
Topomax or topiramate has gone generic as of April 1, 2009. The FDA reported that the drug would be marketed by a host of pharmaceutical companies including Roxane Laboratories Inc., Par Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., and Barr Laboratories Inc.. One significant difference is that the prescribing information and labelling will differ from the brand name because not all of the patents and exclucivities have expired. Therefore, generic topiramate has been approved for siezures only. That is not to say that it won’t be prescribed off label for migraine prevention.
Along with Topamax becoming available in generic form, Johnson and Johnson is cutting 900 jobs in the Ortho-McNeil-Janssen unit due to a 35%sales decline for Risperdal, its biggest seller. Most of the job cuts will affect pharmaceutical representatives. So I guess having generic drugs available can be a detriment to some.
Debbie,
I’m so glad I found your blog and I hope you are doing well. I have always had migraines, but due to a car accident, they are now worse. The accident-related ones I get are due to a strain in my back, up my neck, and directly down to my eye. It’s hard in addition to the other chronic pain and I am concerned that I will lose my job.
Anyway, thanks for writing about this. Triptans work best for me, but even with Imitrex being generic now, my horrible health insurance only allows for four pills per month. My doctor now has me on the generic Topamax, but I just read that it can also interfere with the birth control pill. It’s always something!
Anyway thanks again.
Tara
Tara,
Thanks for the comment. I was rear-ended 4 years ago and I believe that my migraines got worse. I am happy that triptans work for you, but a measly 4 pills a month would not cut it for me! It would last one week. I am blessed that I am allowed 12.
I found this information about the deaths and breathing problems brought on by Botox.
“In February 2008, the FDA announced that it is currently conducting a safety review of Botox after receiving information about adverse reactions to it, including breathing problems and some deaths. It’s important to note that the deaths involved off-label use of Botox in a treatment for children with cerebral palsy. The FDA is still reviewing these adverse events and will provide updates as they become available. ”
Retrieved from- http://www.everydayhealth.com/headache-migraine/botox-to-cure-headaches.aspx
Thanks for your articles.
As a daily consumer of 200 mg of Topamax for my migraines, I did a lovely jig when my co-pay dropped to 10 bucks!
Glad I stumbled onto your blog. =D
how come I can’t read your blog on my blackberry (bold 9000)???