DEMAND THAT THE FDA APPROVE AND RELEASE SUCRAID IMMEDIATELY TO PATIENTS MEDICALLY IN NEED
This petition made change with 1,246 supporters!
Many people take for granted the most simplest things in life. For example, the ability to eat food.
What if you could not survive on food without the need of medication? What if you were told you can only eat less than 20 foods or even NONE without medication? What if the only thing that gave you the opportunity to survive was a medication and without this medication your body gets extremely sick? What if this highly needed medication was NOT available anymore?
This situation is exactly what several children, teens and adults are stuck in RIGHT NOW!
There is NO MORE SUCRIAD currently available to the public right now. http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Sacrosidase%20(Sucraid)%20Oral%20Solution&st=c&tab=tabs-4
QOL Medical produces America with this life changing medication called SUCRAID that is used to help patients diagnosed with Genetic/Congenital Sucrase-Isomaltase Deficiency.
What is GSID/CSID?
According to QOL MEDICIAL- SUCRAID.NET:
"Genetic Sucrase-Isomaltase Deficiency/Congenital Sucrase-Isomaltase Deficiency is a rare disorder that affects a person’s ability to digest certain sugars due to absent or low levels of two digestive enzymes, sucrase and isomaltase. Sucrase and isomaltase are involved in the digestion of sugar and starch. Sucrase is an enzyme produced in the small intestine that aids in the breakdown of sucrose (table sugar) into glucose and fructose, which are used by the body as fuel. Isomaltase is one of several enzymes that helps digest starches.
Genetic Sucrase-Isomaltase Deficiency/Congenital Sucrase-Isomaltase Deficiency is also known as SI Deficiency, Disaccharide Intolerance I, and Congenital Sucrose Intolerance. This disorder is equally prevalent in males and females. Failure to absorb dietary sucrose and starch may impact the absorption of other nutrients and the hormonal regulation of gastrointestinal function. Unabsorbed carbohydrates inhibit gastric emptying, accelerate small-intestinal transit and contribute to malabsorption of starch, fat, and monosaccharides.
Patients with Genetic Sucrase-Isomaltase Deficiency are at risk for chronic malnutrition; indeed, failure to thrive is one of the characteristics of the disease state. In addition to diarrhea, some patients suffer from gassiness, abdominal distention, and pain." https://www.sucraid.net/about-gsid/
I and many other families, parents and patients are demanding that the FDA immediately release SUCRAID to patients who are in need NOW!
Why is there no SUCRAID?
According to the CEO of QOL Medical who is the maker of SUCRAID:
"We have built this new facility, transferred the manufacturing process, begun production, and filed the necessary regulatory application with the FDA for approval in less than a year. We have produced Sucraid® in the new facility and are awaiting final regulatory approvals for distribution."https://www.sucraid.net/wp-content/uploads/2016/03/DearSucraidPatients.pdf
Many patients and parents of patients have been signing waivers for months to get NON-FDA approved SUCRAID due to the extreme shortage of SUCRAID. SUCRAID was being produced in a food grade manufacturing process while QOL Medical worked on establishing a new facility.
RIGHT NOW there are hundreds of bottles of SUCRAID waiting for distribution and the only hold up is the FDA.
RIGHT NOW there are several patients without medication waiting for the FDA.
RIGHT NOW there is a child taking their last dose of medication waiting for the FDA.
Many patients and families are questioning as to why we are not allowed to sign a waiver as we have previously been doing so for months. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM454056.pdf
PLEASE JOIN ME IN DEMANDING THIS NEEDED CHANGE!!
This petition is demanding the FDA to:
1. Demand the FDA to immediately distribute the manufactured SUCRAID lot that is currently waiting for FDA approval.
2. Demand the FDA to allow patients or parents/guardians of minor children the option to waive FDA approval on the manufactured SUCRAID and immediately release this SUCRAID lot for distribution.
Today: Tiffany is counting on you
Tiffany Fargnoli needs your help with “FDA: DEMAND THAT THE FDA APPROVE AND RELEASE SUCRAID IMMEDIATELY TO PATIENTS MEDICALLY IN NEED”. Join Tiffany and 1,245 supporters today.