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.
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.