Member Interview on Reclast and FDA Testimony
We’d like to welcome one of our members, Jerri Iehl, who has osteoporosis and was treated with Reclast. As a result of her medical issues during treatment, Jerri was selected to testify before the Food and Drug Administration (FDA) on bisphosphonates in September 2011. Jerri will take us through her treatment and the medical issues that occurred while she was treated for osteoporosis.
Since we all react differently to these drugs it’s best to educate ourselves as much as possible and weigh the risks and benefits that may occur with this type of treatment for bone loss.
Biography: Jerri Ann McIntosh Iehl, born November 9, 1958 in Iowa City, Iowa. I grew up in Charles City, Iowa, and moved to Waterloo, Iowa on graduation day from high school. Shortly thereafter I met the love of my life, Rex Iehl, and we were married on April 1, 1978. We just celebrated our 34th wedding anniversary. We have three children: Erica (32), Jeremy (31), and Ryan (29). We also have 13 grandchildren, which are the love of my life.
After graduating from high school, I worked in the legal field for about 10 years. I then went into telemarketing, where I was a supervisor. After a period of time I decided to go to college and so I went to the University of Northern Iowa where I obtained a Bachelor of Science Degree in Communication and a Minor in Journalism. I also received the Purple and Old Gold Award for Journalism, which is only given to one student per semester.
After graduation, I moved to a small town and became their Editor of their newspaper. I did this for as long as my body could take the long hours. I then went back into telemarketing. In 2005 I ended up becoming totally disabled due to having Stickler Syndrome, which is a degenerative bone disease. I have had to date over 70 bone surgeries due to this disorder.
Help me welcome Jerri
Q: Jerri when did you first find out you had osteoporosis and how severe were your T-scores?
A: I saw my physician regarding my joints in early May of 2010 and he decided that I may have an issue with osteoporosis so he ordered a bone scan. On May 11, 2010 I had my first bone scan. Below are the results:
Total Hip T-score: -3.8
Total Spine T-score: -2.0
World Health Organization classification: Osteoporosis
Fracture Risk: Increased
My second bone scan was performed on 08/23/2011_._
Total Hip T-score: -2.8
Total Spine T-score: -1.9
Classification: Osteoporosis, patient is high risk for fracture.
Q: What treatment did you and your doctor decide would be best for your bone loss?
A: When I had the first bone scan, my physician immediately recommended the Reclast. With the second bone scan, my physician recommended Forteo.
Q: Did you have any problems with this treatment, and if so, did the doctor inform you in advance what to expect?
A: I had horrific reactions to the Reclast. The only side effects that I was told to expect was that I might have “flu-like symptoms” or “some slight bone pain that I could take some Ibuprofen or Tylenol for and that would take care of it,” or in some “extremely rare circumstances” people have “renal failure.” That was all I was told period!
With regard to the Forteo, I was given a pamphlet that had a whole list of different reactions that I could have, including the possibility of cancer, but as of this date, I haven’t had any side effects from it and my bone scan showed remarkable improvement in my numbers.
Q: Since you have had many issues with this treatment, what was the first thing you noticed after having the infusion? The drug company tells us that it can cause flu-like symptoms, kidney problems; severe bone pain, atrial fibrillation and those with pre-existing kidney disease or gastrointestinal resectioning surgery should not be treated with this drug. Did you experience any of these side effects and did you have any of the contraindications (i.e. kidney disorder or gastrointestinal resectioning) listed by the drug company? Did your doctor inform you of all these things listed on the package insert for Reclast?
A: The first reaction that I had to the Reclast was the severe bone pain and fever. After taking the Reclast, my fever rose to over 103 degrees, and my normal temperature is less than 97 degrees so this was extremely high for me. My heart was racing and the bone pain was unbearable. Nothing that I took for it would take care of it. I ended up in the Emergency Room where they gave me fluids to help bring down the temperature, IV pain meds, and something to bring down my fever. They sent me home and said that if I wasn’t better, to come back. Well, I ended back up there after the meds wore off as my temperature rose right back up there again and so did my pain level. It was horrible! This went on for 3 to 4 days.
The next side effect that I noticed appeared about two weeks after my infusion. When I awoke, my hand was really hurting. I looked at it and there was a lump on it that hadn’t been there when I went to bed the night before. It was hard and painful to the touch. I showed it to my husband and he said he didn’t remember it being there either. The next time I saw my doctor, I asked him about it and he said it was a bone spur. He said that they form on the nerve and that is what makes them so painful. By the time I saw him, it had been three to four days later and I had four to five of them. He said it had to be the Reclast that was causing them because there was nothing different that I had that would have brought them on that quickly. To this date I have between 80-90 all over my body, including my hands, my feet, my ribs, my shoulders, my back (including my tailbone which makes it very difficult to sit), my hips, and even my lungs! I also suffer from the severe bone pain constantly. It will probably be with me for the rest of my life.
About a month after having my infusion of the Reclast, I was sitting on my couch and all of a sudden I felt this tightness in my throat. Then my heart began to feel like an elephant had just sat on my chest and my heart began to race so fast that I felt like I was going to pass out. Then I got really nauseated to the point that I thought I was going to throw up. I raced to the bathroom as fast as I could go. By the time I got there, I felt like I was going to have to go from the other end. I didn’t know what end to put on the stool. I finally grabbed an ice cream bucket and held my head over that and hoped for the best. This whole scenario lasted for about 20 minutes. My husband wanted me to go to the hospital but I couldn’t get off the stool. Everything was pouring out of me from both ends. There was no way I could go.
My husband made me schedule an appointment with my physician to find out what that episode was. I explained it to him just as I did to you all and he said, “It sounds like you had an atrial fibrillation attack.” He ordered a 24 hour halter monitor and from that study it did prove out that this is what had occurred. He also scolded me for not calling an ambulance. He told me that if it ever occurred again that I should call an ambulance.
Well, as my luck would go, I was home alone the next day and I had another episode. I didn’t know what to do, so I went next door to my neighbor’s house as she is a registered nurse. She took one look at me and she dialed 911. The rescue squad came and they examined me and it wasn’t long and they had me loaded up in the ambulance. They tried to get a line in me to give me meds, but they were unsuccessful. They ended up giving me a shot just to get my blood pressure in line. By the time I got to the hospital, I was in full atrial fib. They worked on me for awhile until they got me straightened out. I was put in the ICU overnight for observation. It was a scary episode.
The sad part of all of this is that I discovered that I never should have been given this drug in the first place. I had a gastroplasty and roux-en-y surgery and according to the FDA’s guidelines, it states that people that have had previous gastrointestinal resectioning surgery should not have this surgery. I, being the obedient patient, did not question my physician and just went and had the infusion. Never again! I showed him the article and he said that he had never read it. But this did nothing for me. My physician did not inform me of any of the side effects that were on the package insert except for the ones that I stated as above.
Q:** Osteonecrosis of the jaw** (ONJ) is also listed as a side effect of all bisphosphonates (Actonel ®, Boniva ®, Reclast ®,** Fosamax ®, Didronel ®, Aredia ®, Zometa ® and Aclasta ®) along with femur fractures; did you sustain any injury to your jaw bone and mouth or femur (thigh bone) fractures** from this treatment?
A: In June of 2011, I had a tooth that became infected and needed to be pulled. I went to my local dentist and asked if I could have it treated, given that I had been infused with Reclast. He informed me that “it would be no problem” given that it had been over a year since my infusion. He also pulled another tooth that was looking bad as well.
About a week later, I began pulling pieces of bone from both of the places where he had pulled the tooth from. There was one piece that I couldn’t get out, so I called the dentist for assistance and to ask what was happening. He replied that this was “perfectly normal!” and that this was “knuckle bone” that was coming out and not to worry. He pulled the piece out and said if more came out to just pull them out and I would be fine.
Well, I had several more pieces come out and then all of a sudden I had what appeared to be like baby teeth growing where the old teeth had been. I also had a protrusion at the back of my jaw, but it was towards my tongue and it was sharp and painful. It was rubbing my tongue raw!
I decided I had enough of my dentist here, so I asked for a referral to our college dentists at the University of Iowa Dental College_. They obliged, so I saw them on July 28, 2011. They examined me and said that it wasn’t new teeth that were coming in. Instead it was still bone coming out from the hole. That he hadn’t pulled all the roots of the tooth. It had grown clear down to the jawbone. It took nearly an hour and a half for him to pull that tooth._
As far as the bone growth in the back, the Dentist said that this was not new growth, but instead this was my jaw bone that was exposed. I had osteonecrosis of the jaw. It was also visible in a few other places where I had thought that new bone was growing in.
I did not incur any injury to my jaw to cause this situation of osteonecrosis to occur.
As far as the femur fractures goes, I have not had it occur yet; however, I have had some scares with regard to it.
Several times during the night I have awoken to severe pain in my right leg, especially in the hip region, where it feels like if I move my leg, it will break. I have to lay there still for a minute or two to gather the courage to move it. I get kind of sick to my stomach when this occurs as the pain is intense. I go to move it - sometimes the joint pops and I stop mid-air to make sure that it hasn’t broken off. I continue to move my leg and sit up and check myself out.
Sometimes this same scenario will occur when I’m standing as well. I will be walking along and all of a sudden my leg will pop and I don’t know if my leg will be able to sustain me in the next step. I once again check myself out, holding my breath waiting to see if my hip is broken.
My physician has x-rayed my hip, but as of this date has not done any of the tests that would show if there are any fractures of the femur that may have occurred.
Q: What treatment have you been told you may be able to have to treat osteonecrosis of the jaw or a possible femur fracture, if they occur?
A: With regard to my osteonecrosis of the jaw, the first treatment that I had was to give me high doses of antibiotics, which worked well in reversing the effects of the osteonecrosis.
The Dentist and Endodontist advised me that there are a couple of teeth that may need to be pulled and if that is the case, they would recommend that I be put in a hyperbaric chamber for 20 days for 90 minutes a day to help with the osteonecrosis. This is an extremely expensive process, and to top it off, it is done on an outpatient basis, so I would need to arrange for either a hotel room, and/or drive back and forth an hour and a half each way every day for those 20 days. This is complicated by the fact that we only have one car. If I stayed in a hotel, many of them have shuttle service to the hospital, if the procedure is done in the hospital and not in a different location from the hospital itself. It is something that we would have to work out.
Q: I know you’ve been in and out of the hospital many times since your infusion; would you mind sharing with us the medical issues that caused you to be hospitalized beyond the initial medical problems you experienced right after the infusion? And what is your prognosis now?
A: Since my infusion of Reclast, I have been hospitalized 6 times for pneumonia; 1 time for the flu; 1 time for infection of my feeding tube, which ultimately had to be removed due to the infection; 1 time for an atrial fib attack, as previously noted; and 1 time for six days for infection in my knee. These are all that I can remember off the top of my head.
Most of these hospitalizations are due to my lack of ability to fight off infections due to Reclast ruining my immune system. Since that time, an Immunologist has diagnosed me as having cyclic leucopenia, which basically means that my time period for being susceptible for infections runs in cycles. Currently that cycle is about every three weeks. I have to be very careful when I am around people. Two of the times when I was hospitalized I had to fight for my very life and came close to losing that battle.
Right now my life is once again in jeopardy. I am fighting to keep my left leg as my orthopedic surgeon has diagnosed me as having a chronic infection in my left knee, which has been replaced twice. He says there is not enough bone in there to replace the knee a third time, coupled with there is a long rod in my leg that goes clear down to my ankle. Therefore, it is his recommendation to remove the leg above the knee.
I have a second opinion appointment scheduled for Mayo Clinic and am awaiting that appointment. Hopefully they will have a better option.
Q: Where are you now with treatment? Have you gone on to a different type of medication for osteoporosis and is it working?
A: I am currently taking Forteo shots every day. I believe they are working better as my numbers increased greatly just in a short time frame. I hope so.
Q: You were able to speak before the FDA on September 9, 2011, do you feel this helped to get the word out on these types of medical problems seen with Reclast and** did it precipitate any label changes** on the drug that you are aware of?
A:** Speaking before the FDA** was a very empowering experience for me. A friend of mine took photos of me with my camera while I was speaking, which helped to preserve the moment for me. After all of us completed our speeches, the Moderator stated that they were going back into their business meeting and it was like we hadn’t even spoken at all. We were all disheartened. It wasn’t until I got back to Iowa and looked at the photos that my friend had taken of me and the crowd that gave me peace about my presentation. I saw that people were actually listening to me. I saw that certain people were upset about what I was saying which gave me much gratitude, and I saw many people were shedding tears of compassion and empathy, which also made me feel like they understood.
About a month after we spoke before the FDA, we heard that there was to be a label change which indicated there was an increased risk of femur fractures for people that take Reclast.
I know our members here at HealthCentral/Remedy Health, are very proud of you and we want to take this opportunity to thank you for giving those patients who couldn’t attend the meeting a voice before such an important panel of doctors, scientists, drug manufacturers and patients. Not everyone can do what you and others did, and it takes tremendous courage, stamina-especially while going through tough medical problems-and fortitude to get up before such a crowd and tell your story!
As I’ve said, we can’t thank you enough and truly appreciate your strength in the face of adversity going to this meeting on bisphosphonates last September. Also, if you can, please try to keep our members updated on how you are doing in the future. I know they all want to know what is happening and only you can fill us in. Your story will help many, and for that we’ll be forever grateful! Keep up the good work, where ever that may take you, and we hope to hear that you’re involved in many other aspects of patient advocacy and education. We also hope that your health improves and that you’ll be able to return and tell us you’re doing much better!
Pam wrote for HealthCentral as a patient expert for Osteoporosis.