Pancrecarb

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Mommafirst

Guest
I sent a letter a few weeks ago, because pancreacarb is the only on that goes through the tube. I haven't heard back. Its incredibly frustrating. I have one bottle left and then what?
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<br />ETA and what the heck, the only FDA issue was a labeling one, so why is this such a big stinking problem?? I mean we were told that we could still get them while the pharmacies still had some. If they were harmful shouldn't they have pulled them completely????
 
R

Rebjane

Super Moderator
Heather,
Pancrecarb is not harmful, to my knowledge. Our CF doc said that Creon had been overfilling the capsules, so Creon 5 actually was really Creon 6; in terms of dosage. All that company had to do was change the label from Creon 5 to Creon 6 etc, make new labels and now they are an "approved enzyme".

In my opinion, it has to do with money, and covering their ass. Each company had to file a New Drug Application which I am sure is alot of money. Enzymes in past had been considered a nutritional supplement, not a drug. Now they are considered a drug thus need to be approved to assure "safety" to the patient.

However, my daughter has been safely taking Pancrecarb for 5 years. I think the patients should have been "grandfathered" into this application process not disturbing the distribution and dispensing of the enzyme. With a fatal disease, in which a basic human need, nutrition needs to be met, I feel the FDA is being negiligant in taking this enzyme Pancrecarb off the market with no equivalent substitute left for our Cf'ers. And this is the essentially what I wrote to them. I left out the negligant (?sp) part. The FDA response of taking another approved enzyme means they just don't understand the issue at hand.
 
R

Rebjane

Super Moderator
Heather,
Pancrecarb is not harmful, to my knowledge. Our CF doc said that Creon had been overfilling the capsules, so Creon 5 actually was really Creon 6; in terms of dosage. All that company had to do was change the label from Creon 5 to Creon 6 etc, make new labels and now they are an "approved enzyme".

In my opinion, it has to do with money, and covering their ass. Each company had to file a New Drug Application which I am sure is alot of money. Enzymes in past had been considered a nutritional supplement, not a drug. Now they are considered a drug thus need to be approved to assure "safety" to the patient.

However, my daughter has been safely taking Pancrecarb for 5 years. I think the patients should have been "grandfathered" into this application process not disturbing the distribution and dispensing of the enzyme. With a fatal disease, in which a basic human need, nutrition needs to be met, I feel the FDA is being negiligant in taking this enzyme Pancrecarb off the market with no equivalent substitute left for our Cf'ers. And this is the essentially what I wrote to them. I left out the negligant (?sp) part. The FDA response of taking another approved enzyme means they just don't understand the issue at hand.
 
R

Rebjane

Super Moderator
Heather,
<br />Pancrecarb is not harmful, to my knowledge. Our CF doc said that Creon had been overfilling the capsules, so Creon 5 actually was really Creon 6; in terms of dosage. All that company had to do was change the label from Creon 5 to Creon 6 etc, make new labels and now they are an "approved enzyme".
<br />
<br />In my opinion, it has to do with money, and covering their ass. Each company had to file a New Drug Application which I am sure is alot of money. Enzymes in past had been considered a nutritional supplement, not a drug. Now they are considered a drug thus need to be approved to assure "safety" to the patient.
<br />
<br />However, my daughter has been safely taking Pancrecarb for 5 years. I think the patients should have been "grandfathered" into this application process not disturbing the distribution and dispensing of the enzyme. With a fatal disease, in which a basic human need, nutrition needs to be met, I feel the FDA is being negiligant in taking this enzyme Pancrecarb off the market with no equivalent substitute left for our Cf'ers. And this is the essentially what I wrote to them. I left out the negligant (?sp) part. The FDA response of taking another approved enzyme means they just don't understand the issue at hand.
 
C

creation301

New member
Once suggestion that I think all of us need to do is write a letter to the senator, governor and attach it to Beth Fritz as well. Our senator wrote a letter on our behalf last week. They told me that by them writing that they might have a better chance of getting somewhere. Don't know if that is true, but it sure is worth a try. We have had a mess for two months trying Zenpep and creon throwing tons of pills, prevacid (tripled) and even tums in an effort to get her body to absorb the "approved enzymes"! UGGGG!!! Not to mention her poor little body have to endure the difference trials.

Anyway, hopefully something happens soon! We only have enough for about a month, and then....back to making my child be a "test mouse" for all the enzymes that don't work. =( Can hardly bear to think of asking that of her again. It makes me mad when cf is hard enough to fight in itself let alone taking away the tools need to fight it. FRUSTRATING!!!
 
C

creation301

New member
Once suggestion that I think all of us need to do is write a letter to the senator, governor and attach it to Beth Fritz as well. Our senator wrote a letter on our behalf last week. They told me that by them writing that they might have a better chance of getting somewhere. Don't know if that is true, but it sure is worth a try. We have had a mess for two months trying Zenpep and creon throwing tons of pills, prevacid (tripled) and even tums in an effort to get her body to absorb the "approved enzymes"! UGGGG!!! Not to mention her poor little body have to endure the difference trials.

Anyway, hopefully something happens soon! We only have enough for about a month, and then....back to making my child be a "test mouse" for all the enzymes that don't work. =( Can hardly bear to think of asking that of her again. It makes me mad when cf is hard enough to fight in itself let alone taking away the tools need to fight it. FRUSTRATING!!!
 
C

creation301

New member
Once suggestion that I think all of us need to do is write a letter to the senator, governor and attach it to Beth Fritz as well. Our senator wrote a letter on our behalf last week. They told me that by them writing that they might have a better chance of getting somewhere. Don't know if that is true, but it sure is worth a try. We have had a mess for two months trying Zenpep and creon throwing tons of pills, prevacid (tripled) and even tums in an effort to get her body to absorb the "approved enzymes"! UGGGG!!! Not to mention her poor little body have to endure the difference trials.
<br />
<br />Anyway, hopefully something happens soon! We only have enough for about a month, and then....back to making my child be a "test mouse" for all the enzymes that don't work. =( Can hardly bear to think of asking that of her again. It makes me mad when cf is hard enough to fight in itself let alone taking away the tools need to fight it. FRUSTRATING!!!
 
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