I wanted to warn all of you about calling the prescription drug help lines and share my experience.
I had been taking orencia infusions. A couple hours after my second infusion, I developed a fluid fluid bump (kind of like edemia) right above my ankle bone on my right foot. I had trouble walking on that ankle from the pain. I went to my dr. the next morning. I had developed a bruise on top of the swelling due to my new puppy jumping on it the night before (I am taking prednisone and brusing at the slightest light bump). My dr. looked at the bump and felt that it was probably a broken blood vessel that had drained to my ankle and that the blood had pooled there and would drain out in the next couple of weeks. Later, I noticed a smaller bump on my left ankle.
When it came time for my third infusion, my doctor checked the bump and said that he still thought it was a broken blood vessel and should go away. No of this is listed as a side effect from orencia so we went ahead with the third infusion.
Soon afterwards, the bump on my left ankle got a little bigger and both hurt. After a couple of weeks, in a moment of weakness and pain, I called the orencia help line to see if any one else had reported fluid filled bumps on their ankles. I was passed from person to person and talked to one of the nurses. I asked her if they had any reports of a fluid bumps on the ankles. I explained to her that I had gotten some after my infusion but we weren't sure what they were from and my Dr. felt that they were blood pooled from a broken blood vessel. She asked if it would be okay to make a safety report which I agreed to. I even had a follow up conversation with one of their doctors who wanted clarification on my bumps. He and I talked about the drug and that I planned to continue taking the infusions so I could get to my 5 infusion and see if this helped. At no where in any conversations did they mention that by talking to them and "reporting this side effect" would I no longer be able to take the drug.
A week later my Dr. called me and told me that he could no longer give me the orencia since I had made a consumer complaint and it had been reported to the FDA. I was shocked. Never did I expect to be forced off the drug from naively calling the help line to ask a question. My dr. informed me that they take any calls very seriously. Even if I had hung up before making the safety report, they would have tracked me down from my phone number and gotten the report. While this is good that they are agressive about any side effects, it is very discouraging to me since this was my last hope except AP therapy for calming my disease and to keep working. I was half way through seeing if this worked and had put a lot of time and effort in it.
My suggestion to anyone who may call one of the help lines to ask a medical question is to use a pay phone or other remote phone and be very careful giving your information. This may have been for the best since we don't know what caused these bumps. However, I feel very taken advantage of by the drug company. And, eventhough I am now off the drug forever, my doctor has to give monthly reports to them on my condition for ten years. He really could use that time to perform more worthwile efforts like treating people.
Anyways, just my word of warning to everyone.
When my husband reacted to Bextra, nothing was ever done. They said that drug would not cause that reaction. It was not reported. Months later, an ortho gave me samples of Bextra and I refused them because of my husband's experience. He rolled his eyes and gave me Vioxx.
Two weeks later, Vioxx was pulled. Shortly after, they pulled Bextra. How many suffered during the time that passed while these events were unreported?
At the very least, someone who has the same experience as you on Orencia will know it might be a side effect, as opposed to maybe going through tons of diagnostic tests.
I like what Lorster said, too! A poster on another board didn't feel quite right after one Humira injection, but they did the second. She is still recovering nearly a year later, and they can't really say exactly what happened. Yes. It may have been for the good. However, it would have been informative of them to tell me when they were taking the report that I would have to stop taking the drug. I think people need to be aware of that before the call the help lines. At this point we are not sure if it is from the orencia or all the other problems I have going on.I wonder if it was more of your doctor's decision than the help line? I know calling them got the ball rolling, but maybe they didn't tell you you might have to stop the drug because it was really up to your doctor? No. Orencia sent my doctor a note saying since I had called and they were reporting my call to the FDA, he is not allowed to give me orencia anymore.You know what? I'd say Orencia has heard about this before, or they wouldn't have done that.
I saw a warning for something on the FDA Alert site, and e-mailed them a question, because it didn't quite match my daughter's symptoms. They replied it was possible she had a reaction and "urged" me to file a report. When I did, I received a generic thank you that said it would be filed and I would contacted if they needed more info, and that it only takes a few well-documented cases to start more studies.
It sounds like in your situation, they were already there, and Orencia knows it. I think you should be relieved you aren't taking any more risks, although I can see why you are disappointed.
Thank you for this important heads-up. I agree that it may have been for the best, but I think it was under-handed of the drug company the way they handled it. As a consumer who called in good faith and with a valid question, they should have made you aware ahead of time that by making a "complaint" (it just sounded like a request for information to me) you would be forever barred from this drug. And what's this business about tracking you down by your number even if you hung up? What if you got to that particular branch of the hotline by mistake? Were they going to assume you had a complaint and still bar you forever? I don't understand that part at all.
Wow I am sorry this happened. I think you should have been told up front. And why have a hotline for just questions if it turns out you can no longer take the drug.
Shouldn't they stop you from taking a drug when they know for a fact something is going on?
Thanks for the info...I will never "complain" to the drug company about side effects. I prefer to make my own decisions, in consultation with my doctor, regarding whether I stop or continue a medication. With RA it's almost impossible to know if something is a side effect of a medication or a symptom of the disease. I'm sorry this happened to you.
Alan
I called with a question regarding Rituxan. They said thley had to report it as it was a possible side effect. Then they sent me a questionairre by mail. I completed it and sent it back.
They were very appreciative of my help and I thought it was very thorough of them to report to the FDA any sort of possible side effect.
Neither the drug company or my RD mentioned anything about stopping the treatments and so there have been no negativeconsequences in my case about reporting. That leads me to believe they had prior information that the kind of problem/reaction you were having could lead to something serious and that is why they refused to have you on Orencia any longer.
Just a theory, but it makes sense. Otherwise, why would I have been allowed to continue on Rituxan?
What do you guys thinK?
I agree. It sounds like there's something more going on with the Orencia than just this one question of yours. As crispy said, they didn't stop her from taking Rituxan(sp) when she called. Although I know this is probably a huge disappointment, it may be that it saves your life.