Johnson & Johnson Adds Warning Label to Arthritis Drug Remicade
Source: U.S. Food and Drug Administration
The rheumatoid arthritis drug Remicade from Johnson & Johnson has new warning labels following reports of patients on the drug suffering from blood disorders that in some cases were fatal, the U.S. Food and Drug announced last week.
Johnson & Johnson sent a letter to doctors earlier this month that said, “The causal relationship to Remicade therapy remains unclear. Although no high-risk group(s) has been identified, caution should be exercised in patients being treated with Remicade who have ongoing or a history of significant blood abnormalities.”
J&J added: “All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood” abnormalities or infection while on Remicade. Discontinuation of Remicade therapy should be considered in patients who develop significant blood abnormalities.”
Remicade has been taken by 509,000 patients worldwide, J&J wrote in the letter.
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Tags: remicade
August 29th, 2009 at 6:33 am
My father had psoriasis terribly, however none of the children had ever shown signs of it until I gave birth to my first child. My sister’s feet used to crack terribly, but she never developed what I would consider Psoriasis. The plaques began to get larger, cover areas that had never had any type of development or signs of it. I tried everything over the counter, lets not forget I just gave birth to a baby who is needing my attention because his dad and I were at the age that we still wanted to come and go, but mainly put the child care on me. He was self-employed, which didn’t always guarantee he would be able to help with the finances. At this time we lived in Columbus, Ohio and I was going to the Dermatology clinic. We had tried everything from UVB Rays to medication to salves with no sucess. I continued to work with the plaques getting larger, yet thicker, skin breakage with bleeding and seeping of clear tacky liquid. Bathing was horrible. It was so painful, I still remember crying and talking myself into getting into the tub and soaking or taking a shower. In the tub, I would use sea salt which did help a little but at this time I was only in my early 30′s and felt like how could anyone want to have anything to do with me, yet have a relationship. So you see this skin affliction affects the patient in so many ways that you would do ANYTHING to make it go away or at least find something that would give you some relief from the pain, emotional stress, fatigue, and self-confidence that it robs from you. My father had a history of heart problems and required surgery. We were told that this would be the last opportunity regarding by-pass because the heart was so damaged from the first heart attack he suffered. He was in the United States Navy for 32 years and never missed a day until his first heart attack. He believed he had the flu when in all actuallity he was having a Myocardial Infarction and had sat there at home for 3 days before he was so bad he went to an ER for medical help. He suffered from Psoriasis on his arms, legs, scalp, and feet. They prescribed some type of tape, placing it on the areas affected and it began to heal and clear up. If he didn’t keep up with it, it would return. My son, Zachary and I relocated to Missouri and began a new life. I was pregnant for the second time. Gary chose to come out later and we lived with my sister and two children in KC. After my father was discharged we were informed he would only have a short time to live (6-8 months max), so my sister and I relocated in Joplin, Misssouri. My mother had been seeing a physician, Dr. Michael Joseph, M.D. He is also a Professor at the Oklahoma State University (don’t quote me on that one), but my mother could see how miserable I was and had heard he was seeing patients who were afflicted with Psoriatic Arthritis. That described me to a “T”! I had to small children who were ill at birth requiring surgery at Children’s Mercy Hospital, and the physician, Dr. Craig Friesen could see how it was affecting me as well. Not eating, sleep deprived, joints that hurt so bad, just looking at them made me cry, but I knew I had responsibilities and what made it even better was I had a Great Support System called “FAMILY.” I decided to attempt to go back to school and learn the art of Surgical Technician passing instruments to surgeons as they needed them. Years later after I was dismissed from the program because I missed one question too many, I learned the real reason I was not passed on to the next quarter was because of my Psoriasis. The class I was in required you to change into scrubs and some of the class members had went to the teachers with the concern that my flaking of skin would contaminate something not intentionally, but this was not how it was brought to my attention, I was failed. So I took a few days, my kids, money, and headed for Ohio to spend time with Gary. I could see things had changed for us, and he was involved in a new situation with someone. After a couple of days, I loaded up the kids, said my good-byes and returned to Missouri. I walked in my mothers house, fell into her arms and knew I had made the right choices for my children and myself. I began a position in the St. John’s CVOR learning many new and exciting things as well as why my Dad had left us so early, he was only 63. It was my mother who scheduled an appointment with Dr. Joseph,M.D. and assistant Janet. They said I had the worst case of Psoriatic Arthritis they had ever seen in their medical career. We took pictures and supplied copies to them to show to the Remicade Representative. I have to admit I was a little skeptical because I thought I had tried everything and “here we go again!” Well that wasn’t the situation at all. After my second treatment I could see improvement in my skin, joints, and self-confidence as an individual, mother, and Patient Care Specialist. I had such a “Passion” for my job and would work till I had to be run off. I kept every appointment I had for my Remicade Infusion only having a flair up or two. I had to work on my Blood pressure though, that too, I had inheirited from my father, thus I experienced reactions where I became bright red, couldn’t speak, and had chest pains as well. After being attended to by the infusion nurses and Dr. Joseph I consulted a cardiologist who agreed that the blood pressure medicine Dr. Joseph prescribed would control it as long as I remembered to take it. So now, after 8 years, I am fully healed from the plaques of the Psoriasis and feel relief in my joints because of the development of Remicade and the True Compassion of Dr. Michael Joseph, M.D. I have never met a physician who will help, do, take the time to listen, even if he has 30 more patients to see that day to make sure you’re getting better, not worse, have your medication, make sure you see the best physician who can truly help improve or atleast point you in the right direction. There is nothing better than to go to your infusion/appointment and know not only did he restore “you”, but to see a smile on his face knowing “it just made his day to see one of his patients with a new look at life.”
I don’t know if you have any type of an Award or Acknowledgement for physicians who go above and beyond, but you should. This man has gone as far as enlarging his office, staff, informing patients who financially could not afford this medication without assistance, greets everyone he comes in contact with, a welcoming smile, but let me tell you, if you don’t follow his orders….RUN FOR COVER, YOU’RE IN BIG TROUBLE!” Basically, he truly cares about his patients and in today’s medical society, that is extremely rare. They are only concerned with how much they will be reimbursed by insurance companies.
I would appreciate your sharing this with the Executive Administration so they know just how much their Medication Administration affects those patients who benefit not only from Remicade, Johnson & Johnson, the Representative who visits with the office to make sure things are running smooth, but with the “one” person who returns life to the way it was before this horrible skin disease begins to take it from you.
My appologies for being so “wordy”, but felt you would not understand or begin to know how much he does for people in this area who struggle for good medical care and advice.
Sincerely,
Patricia S. League
Remicade Patient