Pancrecarb

R

Rebjane

Super Moderator
I got an e-mail from Beth Fritsch (sp?) from the FDA this morning with concern to the Pancrecarb issue, finally. About 2 months after my original e-mail. It was pretty much saying they have found problems with the unapproved enzymes and can not allow patients to take them when there are approved enzymes. She also stated by letting people take unapproved enzymes it hurts the drug approval process...If I could copy paste the email I would; but I lack computer capability.(meaning I am computer challenged<img src="i/expressions/face-icon-small-smile.gif" border="0">).

Anyway, I immediately replied with my concern that there is no equivalent substitute for pancrecarb. It is the only enzyme buffered in bicarb. I went on and on...Let her know I have been an RN for 16 years and am well aware of policy and procedure which tends to put the patient last. I hope my e-mail makes an impact...Anyone have any other suggestions..I feel that my background as a nurse may give us a voice?


My husband is also a scientist and actually does have a small grant from the CFF(I did not throw his background in)..But seriously, this fear of litigation which defines all of our policies has taken things and is ruining medicine.

Rebecca
 
R

Rebjane

Super Moderator
I got an e-mail from Beth Fritsch (sp?) from the FDA this morning with concern to the Pancrecarb issue, finally. About 2 months after my original e-mail. It was pretty much saying they have found problems with the unapproved enzymes and can not allow patients to take them when there are approved enzymes. She also stated by letting people take unapproved enzymes it hurts the drug approval process...If I could copy paste the email I would; but I lack computer capability.(meaning I am computer challenged<img src="i/expressions/face-icon-small-smile.gif" border="0">).

Anyway, I immediately replied with my concern that there is no equivalent substitute for pancrecarb. It is the only enzyme buffered in bicarb. I went on and on...Let her know I have been an RN for 16 years and am well aware of policy and procedure which tends to put the patient last. I hope my e-mail makes an impact...Anyone have any other suggestions..I feel that my background as a nurse may give us a voice?


My husband is also a scientist and actually does have a small grant from the CFF(I did not throw his background in)..But seriously, this fear of litigation which defines all of our policies has taken things and is ruining medicine.

Rebecca
 
R

Rebjane

Super Moderator
I got an e-mail from Beth Fritsch (sp?) from the FDA this morning with concern to the Pancrecarb issue, finally. About 2 months after my original e-mail. It was pretty much saying they have found problems with the unapproved enzymes and can not allow patients to take them when there are approved enzymes. She also stated by letting people take unapproved enzymes it hurts the drug approval process...If I could copy paste the email I would; but I lack computer capability.(meaning I am computer challenged<img src="i/expressions/face-icon-small-smile.gif" border="0">).
<br />
<br />Anyway, I immediately replied with my concern that there is no equivalent substitute for pancrecarb. It is the only enzyme buffered in bicarb. I went on and on...Let her know I have been an RN for 16 years and am well aware of policy and procedure which tends to put the patient last. I hope my e-mail makes an impact...Anyone have any other suggestions..I feel that my background as a nurse may give us a voice?
<br />
<br />
<br />My husband is also a scientist and actually does have a small grant from the CFF(I did not throw his background in)..But seriously, this fear of litigation which defines all of our policies has taken things and is ruining medicine.
<br />
<br />Rebecca
<br />
<br />
 
I

izemmom

New member
What does she suggest for those of us for whom Pancrecarb is the ONLY enzyme that works? We've exhausted creon, pancrease...and there have been others.

Would you PM me her e-mail or other contact information, please? I've stayed quiet on this so far, watching to see what would happen. We have enough Pancrcarb stockpiled to get us through the summer, but clearly this is going to go on longer.

I need to speak up for my own peace of mind.

Thanks for being vocal about it. I need to be moreso.
 
I

izemmom

New member
What does she suggest for those of us for whom Pancrecarb is the ONLY enzyme that works? We've exhausted creon, pancrease...and there have been others.

Would you PM me her e-mail or other contact information, please? I've stayed quiet on this so far, watching to see what would happen. We have enough Pancrcarb stockpiled to get us through the summer, but clearly this is going to go on longer.

I need to speak up for my own peace of mind.

Thanks for being vocal about it. I need to be moreso.
 
I

izemmom

New member
What does she suggest for those of us for whom Pancrecarb is the ONLY enzyme that works? We've exhausted creon, pancrease...and there have been others.
<br />
<br />Would you PM me her e-mail or other contact information, please? I've stayed quiet on this so far, watching to see what would happen. We have enough Pancrcarb stockpiled to get us through the summer, but clearly this is going to go on longer.
<br />
<br />I need to speak up for my own peace of mind.
<br />
<br />Thanks for being vocal about it. I need to be moreso.
 
R

Rebjane

Super Moderator
Tami,

That is my whole point...There is no equivalent substitute for Pancrecarb that is appoved. She did not have any input in what we are supposed to do except take approved enzymes.. I think thye do not understand the difference in Pancrecarb..The reason some Cf'ers take it is because nothing else works. That is why they are on it. It is the only one that works well for Maggie too. If you want you can PM me your regular email and I can foward you what I wrote to her and her response.

REbecca
 
R

Rebjane

Super Moderator
Tami,

That is my whole point...There is no equivalent substitute for Pancrecarb that is appoved. She did not have any input in what we are supposed to do except take approved enzymes.. I think thye do not understand the difference in Pancrecarb..The reason some Cf'ers take it is because nothing else works. That is why they are on it. It is the only one that works well for Maggie too. If you want you can PM me your regular email and I can foward you what I wrote to her and her response.

REbecca
 
R

Rebjane

Super Moderator
Tami,
<br />
<br />That is my whole point...There is no equivalent substitute for Pancrecarb that is appoved. She did not have any input in what we are supposed to do except take approved enzymes.. I think thye do not understand the difference in Pancrecarb..The reason some Cf'ers take it is because nothing else works. That is why they are on it. It is the only one that works well for Maggie too. If you want you can PM me your regular email and I can foward you what I wrote to her and her response.
<br />
<br />REbecca
 
A

angelsmom

New member
I also received a response from Beth Fritsch with pretty much the same statement you described. It probably took them all this time to come up with the standard language to be used in all responses to inquiries about the enzyme issue!

My daughter made the switch from Ultrase to Creon, so I am not having the type of issues you seem to be having, but still, I am mad that we even had to switch. We are still trying to tweak her dose and it seems that she needs more capsules of Creon than she needed with Ultrase. I just don't understand what risks to patients there are when so many patients have been using these "unapproved" drugs for many years with no apparent problems.

I do wonder if a phone call to Ms. Fritsch would help to explain the situation better, but I suspect her calls are all going straight to voicemail so she can respond in her own time and with an FDA approved statement!
 
A

angelsmom

New member
I also received a response from Beth Fritsch with pretty much the same statement you described. It probably took them all this time to come up with the standard language to be used in all responses to inquiries about the enzyme issue!

My daughter made the switch from Ultrase to Creon, so I am not having the type of issues you seem to be having, but still, I am mad that we even had to switch. We are still trying to tweak her dose and it seems that she needs more capsules of Creon than she needed with Ultrase. I just don't understand what risks to patients there are when so many patients have been using these "unapproved" drugs for many years with no apparent problems.

I do wonder if a phone call to Ms. Fritsch would help to explain the situation better, but I suspect her calls are all going straight to voicemail so she can respond in her own time and with an FDA approved statement!
 
A

angelsmom

New member
I also received a response from Beth Fritsch with pretty much the same statement you described. It probably took them all this time to come up with the standard language to be used in all responses to inquiries about the enzyme issue!
<br />
<br />My daughter made the switch from Ultrase to Creon, so I am not having the type of issues you seem to be having, but still, I am mad that we even had to switch. We are still trying to tweak her dose and it seems that she needs more capsules of Creon than she needed with Ultrase. I just don't understand what risks to patients there are when so many patients have been using these "unapproved" drugs for many years with no apparent problems.
<br />
<br />I do wonder if a phone call to Ms. Fritsch would help to explain the situation better, but I suspect her calls are all going straight to voicemail so she can respond in her own time and with an FDA approved statement!
<br />
<br />
 
N

NanaOf8GirlsAndCounting

Guest
Pancrecarb is what Graycie uses thur her Mic-key. In fact Cincinnati is out of it and had my daughter bring hers in so that they could put it in her G tube at night while she was sleeping. They are using pancrease now but they are huge. She is hungry so one teaspoon of nonfat ranch dressing with the enzymes during the day is working. It really irritates me that they don't work faster to get this approved . What would they recommend we do to get it into her feeds? We switched to pancrecarb because all the other enzymes were clogging her tube. Grrrrrrr........I would be happy to help write letters regarding this if someone wants to point me in the right direction.
 
N

NanaOf8GirlsAndCounting

Guest
Pancrecarb is what Graycie uses thur her Mic-key. In fact Cincinnati is out of it and had my daughter bring hers in so that they could put it in her G tube at night while she was sleeping. They are using pancrease now but they are huge. She is hungry so one teaspoon of nonfat ranch dressing with the enzymes during the day is working. It really irritates me that they don't work faster to get this approved . What would they recommend we do to get it into her feeds? We switched to pancrecarb because all the other enzymes were clogging her tube. Grrrrrrr........I would be happy to help write letters regarding this if someone wants to point me in the right direction.
 
N

NanaOf8GirlsAndCounting

Guest
Pancrecarb is what Graycie uses thur her Mic-key. In fact Cincinnati is out of it and had my daughter bring hers in so that they could put it in her G tube at night while she was sleeping. They are using pancrease now but they are huge. She is hungry so one teaspoon of nonfat ranch dressing with the enzymes during the day is working. It really irritates me that they don't work faster to get this approved . What would they recommend we do to get it into her feeds? We switched to pancrecarb because all the other enzymes were clogging her tube. Grrrrrrr........I would be happy to help write letters regarding this if someone wants to point me in the right direction.
 
R

Rebjane

Super Moderator
Cheryl,

You can send your e-mail letter to Beth Fritsch at the FDA. Her email is Beth.Fritsch@fda.hhs.gov.

I know you have your hands full but sending your personal issue with CF and Pancrecarb I am hoping will help shine light on this issue. CF is a rare disease and we need everyone speaking up.

Rebecca
 
R

Rebjane

Super Moderator
Cheryl,

You can send your e-mail letter to Beth Fritsch at the FDA. Her email is Beth.Fritsch@fda.hhs.gov.

I know you have your hands full but sending your personal issue with CF and Pancrecarb I am hoping will help shine light on this issue. CF is a rare disease and we need everyone speaking up.

Rebecca
 
R

Rebjane

Super Moderator
Cheryl,
<br />
<br />You can send your e-mail letter to Beth Fritsch at the FDA. Her email is Beth.Fritsch@fda.hhs.gov.
<br />
<br />I know you have your hands full but sending your personal issue with CF and Pancrecarb I am hoping will help shine light on this issue. CF is a rare disease and we need everyone speaking up.
<br />
<br />Rebecca
 
M

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?

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????
 
M

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?

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????
 
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