Ultrase from Scandipharm - change in caps?

[anonymous]

Hi All,

I'm wondering if anyone has ever noticed big differences in the way that the little beads inside the Ultrase capsules look? Until the last bottle we recieved the little beads were uniform in size and covered with an off white coating. In the last bottle I noticed that the little beads are brown and tan and are irregularly shaped. They are smaller too. It almost looks like the enteric coating wasn't include. I asked my pharmacy to call Scandipharm. They said that variation is normal and the pills are fine. ANd there is no new formulation. Now we are starting to use these capsules (had some left of the typical kind before) and it seems to me that the kids are both having more stools and they are much runnier... and one of them if more fussy than normal.

Now I could just be the paranoid mom... so before I go and refuse our current batch and make an issue of it with Scandipharm I thought that I would check to see if someone has had a similar experience! And it the color and variation really matters!

I would appreciate your input!

Stacy
Mom of 9 month old twins with CF

 

[julie]

If I were you I would be pushey about it, especially if your babies are reacting differently to the ultrase that they have been using all along. Mark uses Ultrase MT20's, but we orders ours 3mos at a time so we are due to order again in January. In the order last month, I didn't notice anything but if I were you... I would talk to scandipharm, arrange to send them back and request they send new ones out. Where do you live? It might also be beneficial to contact the CF chapter in your area, ask if they have had any other MBR's in the chapter mention it-you never know, it really could have been a screw up at the factory (nobody's perfect) or they got to hot on the way to ship and the enteric coating melted off (I know for a fact that IS possible, happened to us on our drive down here to CA two years ago). Fight for it!

 

[JazzysMom]

There was a slight change in the look on Ultrase enzymes ont he outside & the bottle. I can not tell you if the beeds inside also are different because I take the whole capsule. I have no need to open it & honestly couldnt tell you what they look like, but if in doubt contact the company directly. I never had any problems with Schandipharm. They have always been helpful!

 

[anonymous]

I have also noticed the misshapen beads in my daughter's Ultrase MT 20s. Also, there always seems to be a different amount in each capsule. Some don't appear to have as much as others. I haven't noticed a difference in the color though. Her stools are the same but they definitely differ day by day anyway. Good luck finding out some answers. Let us know.

Amy
mom to Allie 4w/CF and Betsy 18months/without

 

[anonymous]

Someone posted on the healthboards site about this. Said they took the enzymes in to their clinic and they were SPOILED!!! But can't get the company to respond, so they switched brands.

 

[Caleblove0802]

My son was hospitalized in October for pseudomonas. When we were at the hospital I noticed that the enzymes that were given to him were different just as explained by Stacy. I asked the nurse if this was normal because my son was only 10 weeks old at the time. She gave them to his dietian who presented them to a rep. from the Ultrase company. The rep informed her that the colors can vary. I just received my son's latest order...and the same thing. I personally think that maybe there is a problem with them. The doctor at my clinic wanted my son to try to be on Creon 5. I think I will try the sample bottles I have now of Creon 5 and see if I see a change in my son. I was going to finish the order of Ultrase first.

 

[anonymous]

I noticed the same, my husband thought I was crazy. Going to my CF clinic today, let you know what is said.

 

[julie]

I honestly wouldn't be surprised if there was a temperature change while they were in storage (this is the only thing that would explain the massive change in all sorts of states around the US) and they were shipped without knowledge.

When Mark and I moved from WA to CA 2 years ago, we drove through Utah and Nevada because we visited family and friends there. We had the same color, size, shape, looked like a smaller amount, that everyone has mentioned here. We ended up spoiling our own enzymes on accident. The doc told us to throw them away and got us new ones as they were useless.

If you guys are having no luck with scandipharm, the FDA regulates them, make a complaint. I GUARANTEE you something will happen then!

 

[65rosessamurai]

I agree with Julie, fight for it!!

Based on knowledge given to me by my sister, who's a doctor, those medications are supposed to be monitored, or within a specific tolerance by the FDA, and that's why you have to get them with a prescription.

There should be steps in getting results, if the pharmacy doesn't respond within a reasonable time, contact the maker, and if that doesn't work, go for the FDA for some help. Good luck!

It's a different enzyme and a long time ago, but I remember leaving my Cotazym S in the sun, or something and they changed from their whitish color to a dark brown. I tossed them, too (it was a bottle I carried around, anyway)

 

[anonymous]

YES!!!! I just opened a new bottle today and noticed the color of the beads were brown and different shapes too? I am going to call them tommorrow. But i have also noticed with the last bottle that my daughters stools were a little oily and smelled alot more than in the past. The beads were the normal white ones? I originally thought the old bottle was old? That is why i threw it away and opened the new one?? I even upped her dose to 1 1/2 -2 caps when she has always taken 1 cap. and it did not help? She never had oily and smelly stools since she has been on the Ultrase. Sounds like they had a manufacturing problem!? Will let you know what i find out??

Blythe
Mom to Brinly w/cf 18 mo and Birgess 4 w/o

 

[anonymous]

I called my pharmacy and they called Axcan Scandipharm... they said it was "normal" that there are variation from cream colored to brown. So... because I'm generally a skeptic... I called them myself today! The customer service folks said that they have gotten lots of calls and that their quality control people have looked into it and they have not found any problems. They said, "It's a variation in the raw materials." I think the weirder part than the color is that they are not uniformly shaped... the whitish ones were pretty well spherical, but these seem to be less round. I still think it looks like they missed the quoting... but I'm not sure what else to do.

Any people else that wonders... please call too... maybe they'll be sure to take a second look. I always keep track of my kids' stools, but am being extra diligent this week.

Thanks for the note.
Stacy
Maren and Berne's Mom (9 month old twins with CF).

 

[anonymous]

On another website, someone was taking about this and was told by her CF clinic that the beads were spoiled. They'd had increased problems with malapsorption and with stomach aches. The company refused to answer their phone calls, the pharmacy kept sending the same spoiled ones, so the clinic switched them over to another brand. No more problems. They also contacted the FDA, but again have heard nothing.

We used pancrease and once in a great while I get a capsule with brown smelly beads or once that are crushed and I just throw them away. Figured they were bad and wasn't going to risk it.

 

[julie]

FDA, FDA, FDA....

 

[anonymous]

When i called Axcan Scan they did say that there was a difference in the color of the beads this batch but that it ran thru the testing and passed quality control fine. They also said Ultrase was on backorder til next week and that there might be a new batch out then? They were very concerened about the change in my daughters stools and they are sending me a UPS label to send them the bottle for further testing. I haven't seen a difference in her stools since using the brown colored beads except that her stools are more creamy and do not stink to high heaven like they used to be with the old bottle. I am going to wait til next week and place on order for more and see what happens... who knows i would rather be safe than sorry!
Blythe
mom to Brinly 18 mo w/cf and Birgess 4 w/o

 

[rose4cale]

Stacy-I wondered about Cale's since we are in the 'same vacinity' and he just got a refill, and his look the same as usual. Hope they get it straightened out. I would be concerned too!!!