Transplant Drug Linked to Birth Defects

29 Oct 2007

WASHINGTON (AP) — A drug to prevent organ rejection in transplant patients may cause birth defects, health officials warned Monday.

The drug, called CellCept, also may cause miscarriages, the Food and Drug Administration added.

The FDA also warned that taking the drug, made by Switzerland’s Roche Holding, may lower blood levels of the hormones in birth control pills, theoretically making them less effective at preventing pregnancy.

Women of childbearing potential should have a negative pregnancy test within a week of starting the immune-system suppressing drug, and must receive birth control counseling and use effective contraception, the FDA said.

Some doctors prescribe CellCept to lupus patients who cannot tolerate chemotherapy. The drug is known generically as mycophenolate mofetil.

(A friend – a transplant recipient herself, is nice enough to send me articles that she thinks we’d be interested in. And yes, I find this very interesting. And scary. Many questions are put in the “To Think About Later File” because it isn’t like we can do it without this drug.)

I’ve decided to commit to doing a post each day in November. It’s something I wanted to try to do last November, but things were shaky on the kidney donor front and it seem overwhelming. Although looking back I probably needed to be getting many things out of my head last year so it could have been the perfect time.

I’ve joined this group – NaBloPoMo at http://nablopomo.ning.com/ – should be interesting. I think I’m going to have a 30 day theme and do regular postings on regular stuff. Also, I’ll have a day of delurking, trying to get some of you to come out of hiding. You know who you are.

I’ve committed. Or I need to be committed. We’ll see which one sounds reasonable at the end of November.

Gage: “Mommy, I like it better when we go to the E.R. in the daytime.”

Jody, if you are a like me you can’t believe that it’s been 7 months already since you entered the hospital one day and gave my son a kidney. I still don’t quite know what to say to you…except for Thanks! You’re Awesome!

Well, that’s not really what I want to say. I want to tell you that even now I remember what it felt like that day. The day I spoke to your husband and you had just been wheeled into surgery. I was scared and thrilled at the same time. That night, several hours after Gage’s new gently used kidney was hooked up and working I saw you sleeping and as I watched you sleep (does that sound creepy?) I cried at the beauty of your gift.

I knew at that moment that we would be connected in a powerful, unique way that I would spend my life trying to explain.

Thanks Jody. I know we’re late sending you a card this month, but even so, we think of you often. Every time Gage wakes up and can enjoy a day free of dialysis.

Your gift amazes me still.

At approximately 9:30 this morning Gage was at school and walking innocently from PE to his classroom.

He walked directly into a pole that supports the breezeway cover. He said he was walking and looking to the side and then turned his head a little and BAM he hit full force. The nurse called me and said he was fine, but wanted me to come see it. He had ice on it when I arrived. He was fine but a little foggy. He didn’t pass out when it happened and he said he felt fine. I considered leaving him at school because it was 9:45 in the morning but changed my mind as the egg sized bump turned a light shade of lavender before my very eyes.

I was fine putting him on the couch with TV to entertain him until he said he felt like he had to throw up. So off to the E.R. we went. Four hours later we were back at home. The doc said it’s a good one that is for sure, but he tested out okay without a CAT scan.

He’s up and running again.

There’s not really a cuter pumpkin patch photo is there? Because I have looked and I can’t find one. I’ve even tried to recreate the goodness in 2004, 2005 and 2006 to no avail.

I have a question for you. I am not sure what kind of meds Gage is now on, but my son has some kidney problems and is on Bicitra. Ever since we have started decreasing his dose, he has acted much like your description of Gage. Have you noticed any difference based on his meds?

Christa in the comments section posed this question.

Around age 5 he went on bicitra and EPO (which helps people with kidney failure and cancer get back some of their energy) at the same time. Gage went off the bicitra when he started dialysis last September, but I can’t say that I noticed if that had a play in his behavior. Gage’s energy, both good and bad, notably increased with the EPO/bicitra start and recently after transplant because of the steroids (he’s on what is considered a "low" dose now) based on the docs and some theories from friends. I will say, in addition, the transplant offered a boost of energy and for Gage, more energy means more impulse control problems. It’s been an adjustment.

The problem with kids on multiple meds is that you really never know. While the doctors have a better sense of med reactions from hearing stories from other patient’s families they don’t really know either. One thing that many parents of ARPKD kids notice as a commonality is behavior problems. This is both true for pre and post transplant kids. Is this a sick kid thing in general or specific to ARPKD or kidney failure?

While I think Gage would have been a challenging child had he not had PKD or OMA, I’m fairly certain he wouldn’t have been such a challenge. I think his issues are a mixture of illness, meds, emotional coping with said illness, treatment, meds and delays. Being a sick kid changes who Gage and Quinn would have been, so their disease/disorder defines them. I’ve had many, many people tell me that we shouldn’t let PKD/OMA define them (or us as a family). The kids are who they are is because of PKD and OMA. It definetly defines this family.

But really, what impacts what? Meds-Behavior? Disease-Behavior? Disorder/Disease-Behavior?  Emotional Health-Behavior?

I’ll always appreciate that there are meds that control the symptoms and help with polycystic kidney disease, kidney failure, dialysis, and transplant but I’ll always worry about the big and small side effects (long term/short term) we don’t know about and certainly those we do because drugs are rarely tested/followed by researchers on children.

It’s nearly November and I haven’t provided a recap as to what is going on with Gage’s behavior since we instigated Operation Get The Power Back.

That could be because I have been so busy actually working The Program trying to get The Power back that I haven’t actually had time to write about The Power.

I guess we have made progress. But I have to be honest, when there is a child such as Gage and his antics, a little bit of progress is A LOT of progress and should be celebrated but it is easy to miss because there are so many issues all the time. I have recently just learned that little tidbit.

So, to recap. We started the behavior modification just over two years ago. One of the main reasons we started seeing a behaviorist (and paying out-of-pocket might I add) was because Gage was treating Quinn poorly. And by poorly I mean aggressive behavior that was dangerous. Two years ago Quinn’s balance wasn’t as good as it is today and Gage screaming at her and/or hitting her while she was at the top of the stairs was a normal activity. We’d tried many things on our own, including taking away all of his possessions, charts, rewards, etc. It wasn’t going well. Before we sought out Dr. KATB (Knows All Things Behavioral) I sat at my desk crying because we couldn’t get in front of the attacks on Quinn. In addition, behavior at school was rough. He was also very non-compliant. By non-compliant I mean Gage pretty much didn’t do anything we asked the first time, and rarely the second. And maybe or maybe not the third. I felt as a complete failure as a parent to Gage. I declared that day that I couldn’t do it.

The Program included ignoring bad behavior, praising good behavior (in the early days all we could compliment him on was standing, holding is fork, drinking water – you get the idea). We also tried to put Gage in situations in which he could be successful and we tried to keep him out of situations where he could get in trouble. As an example, Gage always did horribly in malls or grocery stores. So why did I put him in that situation? I wised up and quit taking him. For at least a year, Gage didn’t enter any kind of store establishment. Each week we would log the behavioral events of the week to discuss with Dr. KATB and take his input, discuss tweaking the program, the good doc would analyze how we reacted in certain situations and tell us why IT WAS WRONG TO REACT THAT WAY and we’d tweak the program some more. Weekly. For several weeks. The progress was slow, but consistent because we were parenting him differently.

It is one of the hardest things I have ever done.

We got to back off of some of the modifications as Gage’s behavior improved and we didn’t see the doc as much. We coasted a little bit. Then Gage started 1st grade and went into acute kidney failure. Then dialysis happened. Then our new normal happened; it was a normal that was so completely not normal it was ridiculous. And then Dr. KATB went on leave for 6 weeks, then we were busy and distracted and his bad behavior crept up on us again. It wasn’t as bad as it once was, but there was certainly a heightened non-compliance issue and impulse control problem. Then he got a new kidney, and then we were all getting back to "normal" and then as quickly as the summer hit, summer was over. Then 2nd grade started. His bad behavior intensified. It was hard on him getting back to the normal routine of going to school again (without being a celebrity at the school) as a healthy child. And well, after a tearful evening while I was cooking Swedish pancakes while having a breakdown and Julian was threatening Gage, a few phone calls and emails were sent to the doc, and that is when we started Behavior Modification Phase 2.

The start of 2nd grade was rocky. Luckily his teacher started the year out with a program for her class that includes "apple sticks" (well, at the beginning of the year they were sticks with apple cut outs on them, and now, the apples are all gone, but we all still call them apple sticks) and if he keeps all sticks that day he gets an apple A+ stamp on his planner that comes home each day. He can earn apple sticks in math and in speech as well. Until recently, he hadn’t received a full week of apple stamps. At least one day – sometimes two in the week – he’d loose an apple stick and not get the A+ stamp. If a child gets 5 A+ stamps in one week, they get to choose a prize from the teacher treat box. Out of all the weeks since school started he has been able to get a treat only a few times.

We’ve also gone back to basics on the program. Ignore. Praise. Rinse. Repeat. Things have improved, ever so slightly.

Last week, I brought Gage with me to see the doc and Gage was very energetic. He didn’t sit still but he wasn’t defiant. Gage sat (Really! He didn’t leave and run up and down the hall and destroy things!)outside the office while I spoke with the doc and the way I kept him near the office was to send notes under the door. He’d return a note back to me. It was all very fun and cute. Much different from the first horrible visit in which Gage’s behavior was noticed as "provocatively" bad with momma. The doc reminded me about the progress Gage had made and it was extremely helpful for me to get that validation. Because it is hard to notice during the middle of working The Program. Gage was compliant in cleaning up paper in the hall. He was compliant putting on his shoes. The doc noticed this and gave me a note to point it out to me. I think I had taken that for granted…the act of asking your child to do a simple task and HE DOES IT. I’m as surprised as I can be that I took that for granted. And I’ve been trying to figure out why I haven’t been appreciating how far Gage has come behaviorally.

It’s because of the day-to-day issues with Gage. People we know and don’t know can’t understand how truly hard it is. They might see him and judge us. They might think that if we were only better parents…it’s also the almost daily notes and emails back and forth from the teachers at his school about the details of his behavior to see if we can tweak anything that will make a difference. It is hard to see Gage’s progress while living the day with him, as he can make it ever so challenging. It’s hard to see that we’ve become the kind of parents that Gage needed because to the outside world, Gage is still a behavior-problem child. Those people in the outside world, they just don’t know what we know.

So, as of today, I’m going to celebrate the progress Gage has made. And I’m going to keep at The Program.

At least until he does something that shocks me and sets me back at little. And then I’ll get to working The Program again.

The Quinn and Her Milestones

I’ve been thinking a lot about milestones as we talk about development and growth around here. There is hardly a day that goes by that we aren’t confronted by Gage and Quinn’s development on a social, medial and educational basis. There are reports and evaluations to turn in and sign, there are meetings to set up, appointments to keep, emails to send with advice on how to deal with a child who is rolling around on the floor in class. Yes, fun times as parents around here.

Quinn is 14 months old in this photo. Because she was a late everything-er she was laying down like this because this is where she was developmentally (about 6-8 months old). She’d just started squatting up onto her knees and hands but it was a hard-earned skill that we only photographed on a couple of occasions. She used a walker from 14-31 months and then she still needed a few more years to feel safe in order to navigate a world of curbs and steps and uneven concrete while walking unassisted.

All the kids in her world adapted to her slow-to-move self and she didn’t mind a bit. After all, they brought her what she wanted, when she wanted, and who wouldn’t want that? Some adults (other mothers for crying out loud) were bordering, if not completely rude. Judgmental even. 

Why is that?

One day, Dawn dared me to write a post about what I saw as benefits to having a child who doesn’t walk until way past the baby book acceptable "normal" range. I told her I thought it might be against my special needs mom code of honor to verbalize it. Late walkers don’t even know there is a whole world up on your desk to terrorize, like her physically agile 3-year-old has known about for a couple of years now. But I have been working on a post in my head and it is a mess in there. In the post somewhere is also an opinion about parents who don’t want their kids seen in public with braces on or using walkers. That one annoys me more than I can accurately describe on paper.

How completely crazy (lucky) is it that I have such talented friends like Marla? Marla celebrated the 15th year in business of her successful restaurant, Babette’s Cafe, and combined the celebration with a fund raiser for the PKD Foundation, honoring Gage and Quinn and Jody’s kidney donation to Gage.

People have done many inspiring things because of PKD over the years. One day I want to list the things I can remember, because you would not believe how long it is. All because one little girl and boy were born with crappy kidneys. If I may say, those kids of ours can inspire some people, no?

Thanks Marla. You’re a helluva of a friend. And you cook real good too.