by ChynnaDoll » June 29th, 2007, 12:39 pm
Hello everyone...checking in. I've been busy trying to get ready for this trip but coupled with that i recieved distressing news about my daughter's MRI results yesterday...NOT good. Nothing seems to be working so now they're going to plan B. She may have to go to Boston for treatment. I really don't even wanna go on this cruise now, but i've paid for it and plus i don't wanna let my friend down. Other than this i have nothing else to say...bare with me.
Suzy, Liz (per request)...here is a portion of an article explaining "one" of the possible procedures Errin will undergo. This one is DANGEROUS and was disputed by the FDA a few years ago after 3 people died while undergoing treatment from subsequently developing (PML) Progressive Multifocal Leukoencephalopathy. It is a Viral Infection of the brain that can occur while on this particular treatment. Needless to say, i am so AFRAID. The other possible treatment is called Gamma-Gobulin which is also an intravenal infusion but less severe, but if she has a relapse during the treatment, she has to wait 3 months before ANY OTHER medications can begin to be administered again. So far NOTHING has worked for her. Her MS has been diagnosed as Chronic Pogressive which has a FAST downhill spiral rate as far as oncoming disability is concerned. Another LARGE active lesion was found on her brain on the MRI results...as a mother i am DISTRAUHGT:+(
Article excerpt:
Because of the risk of PML (Progressive Multifocal Leukoencephalopathy) TYSABRI is
available only through a special restricted distribution program called the TOUCH™ Prescribing Program. Under the TOUCH™ Prescribing Program, only prescribers, infusion centers, and pharmacies associated with infusion centers registered with the program are able to prescribe, distribute, or infuse the product. In addition, TYSABRI® must be administered only to patients who are enrolled in and meet all the conditions of the TOUCH™ Prescribing Program (see WARNINGS, Progressive Multifocal Leukoencephalopathy; and WARNINGS, Prescribing, Distribution, and Administration Program for TYSABRI®). Healthcare professionals should monitor patients on TYSABRI® for any new sign or symptom that may be suggestive of PML. TYSABRI® dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation that includes a gadolinium-enhanced magnetic resonance imaging (MRI) scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.
INDICATIONS AND USAGE
TYSABRI® is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. The safety and efficacy of TYSABRI® beyond two years are unknown.
Because TYSABRI® increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability, TYSABRI® is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate multiple sclerosis therapies. Safety and efficacy in patients with chronic progressive multiple sclerosis have not been studied.
On June 5,
2006, the
US Food and Drug Administration (FDA) approved a Supplemental Biologics License Appl
ication (sBLA) for the reintroduction of TYSABRI® (natalizumab) as monotherapy treatm ent for relapsing forms of multiple sclerosis (MS). We are pleased to be able to once again offer TYSABRI for
appropriate MS patients.