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747159 tn?1293804327

the Enzymes are not working

Good Day, I have auto immune chronic pancreatitis, CLL, had colon cancer, and they once thought I had pancreatic cancer, the fine needle biopsy showed I had it but when they did the Whipple procedure they did not fine it. I was given viokase 8 for years, then they took that off the market and I had to go on creon dr 24,000 units. I have tried this by first taking 2 one before meals and one after meals, it did nothing to help me. So the doctore suggested I take one before the meal, two opened up and sprinkled on my meal and one after my meal. This is not working either. I have stomach pain, nausea, I have more attacks than I was having even though I am on a pain patch of fentynol  50 mcg  every 72 hours. my stool is very sticky and I am extremely tired all the time. I stopped taking the enzymes because they were not working and I had all of these things with and without taking this medicine. I know that they took of the market the viokase 8, but wouldn't you think they would have an enzyme that works for people with a whipple? If you could help with what I should do next would be helpful. I was thinking of making a new appointment with my doctor even though it is the first time in 3 1/2 years they had pushed my appointment to every 6 months. Do you have any suggestions? Thank you for your time and answer. nancy
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747159 tn?1293804327
as of today, they still don't have the ok to put the viokase back into the market. My doctor actually wants me to purchase them from canada, I don't have the money to  purchase them without insurance.
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747159 tn?1293804327
Thank you, I did call them, they still did not get the ok to put these back on the market. It came back with more questions for them to answer. So they are working on it. I just wish that the FDA would know how much people that have had a whipple needs those pills. I can not believe how different these pills are and what type of pain it causes. Thank you so very much for your answers.
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Avatar universal
Nancy, if you check the Axcan Pharma website you'll find the following:

December 1, 2010

Dear Healthcare Provider:

Axcan Pharma US, Inc., (“Axcan” or the “Company”) announced today that the U.S. Food and Drug Administration (“FDA”) has issued complete response letters regarding its New Drug Applications (“NDA”) for ULTRASE® MT and VIOKASE® in the treatment of exocrine pancreatic insufficiency (“EPI”).

A complete response letter is issued by the FDA when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form. The FDA has not requested that new clinical studies be conducted on ULTRASE® MT or VIOKASE® as a prerequisite for approval. Requests raised in the letters primarily relate to certain outstanding chemistry, manufacturing and control data, or CMC, work requirements.

If you or your patients have any questions or concerns, please click here, where further information is available. You can also contact us by phone at 1-877-338-0081.

Sincerely,


You may want to consider contacting them to see if the product will be back on the market shortly, as this was posted in December 2010.
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