Simponi Injectible Pens Recalled
Some injection devices for this biologic medicine are found defective, but many, maybe all, have not yet reached consumers.
By Jennifer Davis
2/22/11 Nearly 900 injectable pens containing the biologic drug Simponi are being recalled in the U.S. because a defect in the delivery device may prevent the administration of a full dose of the medication – a TNF-alpha inhibitor approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
The company that markets Simponi, or golimumab, stresses that most of the affected medication-filled pens were quarantined at the wholesale level before making their way into the hands of patients.
“Nearly 80 percent of the affected unit was quarantined at the wholesale level, and we are working with wholesalers and distributors to recapture the remaining 165 affected units,” explains Monica Neufang, a spokesperson for the drug’s marketer, Centocor Ortho Biotech Inc.
Neufang says the manufacturing defect was detected during regular quality testing in one lot of 50 mg single dose SmartJect autoinjectors, distributed beginning January 26. There were 839 devices in the lot. The lot number is 09D071.AC and can be located on the lower left hand corner of the carton’s back panel.
“I think what’s important to note is it’s a defect in the autoinjector. It has nothing to do with the Simponi medication,” Neufang explains.
Neufang says the self-injectable device is designed to display a yellow indicator in the viewing window when the injection is complete. So if patients get an insufficient dose, the yellow indicator shouldn’t appear. If that happens, she recommends patients talk with their doctor before administering another dose.
As a result of the recall, there is a temporary shortage of the autoinjector pens, according to the Simponi website. However, the drug also comes in a prefilled syringe, which Neufang recommends patients use if they need more medication right now.
“There might be a chance that patients might have to use a prefilled syringe for one month’s therapy, but we will have autoinjectors back for physicians and patients by the end of March,” Nefuang says.
The good news is patients will still be able to get the medication they need. The downside is that using a prefilled syringe means patients will have to see the needle. “The autoinjector is structured in a way that you don’t see the needle entering the skin,” Nefuang says. So some people prefer that because it’s less noticeable that they are giving themselves an injection, but there’s no difference in terms of the medication. It’s simply the route of administration.”
Anyone with any other questions can direct them to the company at 1/877-526-7736 or by visiting the company’s website at www.simponi.com.
Article source: http://www.arthritistoday.org/news/simponi-medication-recall119.php
Mickelson’s arthritis much more trying than he lets on
Following his win in the 2010 Masters, Phil Mickelson had no less than a dozen chances to become the top ranked player in the world. In every instance, Mickelson came up short of what he had to do in order to take the top spot.
Then, at the PGA Championship in August, Mickelson gave what could be interpreted as a reason. He had psoriatic arthritis, a potentially painful condition onset by psoriasis, which typically manifests itself as a skin condition. The pain began around the US Open, but he had waited a few months to tell the world what he had and how he was planning to live with it.
Mickelson downplayed the pain and the issues in learning to maintain a disease that will not go away. He used the holistic treatment of going vegetarian to defer the issue and turn it into a chance to have some humor about the situation.
When he arrived in Abu Dhabi to start his 2011, Mickelson said he had ditched going vegetarian. (It was doomed from the start, really.) If that method wasn’t working, I wondered during a radio appearance if Mickelson was having a much tougher time with the arthritis than he was saying.
Sure enough, he was.
Steve Elling, writing about Mickelson’s runner-up on Sunday at Torrey Pines, alludes to Mickelson experiencing difficulty in trying to deal with the arthritis.
His bout with arthritis he experienced last summer, which he predictably shrugged off with nary a complaint, was far more difficult than he let on. Mickelson said he wouldn’t discuss his medical issues because it would sound like he was making excuses for a sub-standard second half.?
Then, Ellling saw an eye-opening comment from a reader about living with psoriatic arthritis.
“Whatever you have to say about Phil’s inconsistency, his career, or his legacy, remember that he is battling a incurable auto-immune disease and probably takes medication to lower his immunity, making him susceptible to infection and other disease. Those who love Phil should revel in his positivity and enjoy the gusto with which he attacks the course, because with the nature of this disease, it could be over sooner rather than later.”
In short, Mickelson will have to contend with good weeks and bad weeks when dealing with the condition. It is manageable, but sometimes uncontrollable.
With a family member who battles lupus, experiencing similar bouts with another type of autoimmune disease, the struggles she faces really can make life so tough to live.
Article source: http://progolftalk.nbcsports.com/2011/01/31/mickelsons-arthritis-much-more-trying-than-he-lets-on/
Trials available for arthritis, cholesterol – News
Here are the latest clinical trials, courtesy of ClinicalConnection.com:
- Arthritis and cardiovascular disease: This study is for people diagnosed with rheumatoid arthritis or osteoarthritis who may be at high risk for cardiovascular disease. Participants will receive study medication, study-related physical exams, laboratories, ECGs, and compensation for time and travel. The research site is in Austin, Texas. Info: www.clinicalconnection. com/clinical_trials/condi tion/arthritis.aspx.
- Heavy menstrual bleeding and anemia: This study is looking for qualified volunteers to help evaluate an investigational drug to treat iron deficiency anemia. Candidates must be female, 18 or older. The research site is in Lake Worth, Fla. Info: www.clinicalconnec tion.com/clinical_trials/ condition/anemia.aspx.
- High cholesterol: This study is for people who take medication for high cholesterol. Candidates will receive study-related care and study medication at no cost and may be compensated up to $1,500 for time and travel. The research site is in Chicago. Info: www.clinicalconnection.com/clinical _trials/condition/high_ cholesterol.aspx.
Stop Pain With A Psoriatic Arthritis Diet
The following article will discuss a psoriatic arthritis diet that can be used to help the symptoms of the disease. I remember after my diagnosis of the condition being given a 2 page handout explaining the suggested medication for psoriatic arthritis. Early on in the handout it was simply stated that they were not really sure how the drug helped the arthritis but it did. I recall the list of potential side effects just kept going on and on, among them cancer of the liver, in the end it almost seemed worse than having psoriatic arthritis in the first place. A treatment that potentially leads to other diseases like cancer sounds like your just swapping one disorder for the other.
I knew that I would never take medication for this condition. I felt that I had gotten my body into this mess with my lifestyle and eating habits and I would get myself out of it. As Hippocrates, the father of modern medicine said ‘let food be thy medicine’. While there certainly are other factors that play a role in promoting psoriatic arthritis, which will be covered in other articles, this article will focus on a psoriatic arthritis diet. Psoriatic arthritis is an auto-immune disorder, where the body has become hypersensitive and is attacking its own tissue. I do not think the answer for this condition is to laden the body with harmful and toxic drugs.
A basic way to start on a good psoriatic arthritis diet is simply consuming more live foods. This is just eating more fresh food. Food that has not come in a jar, packet, box, carton or packaged on the shelf. Just eat more fruit and vegetables. Things that have a long used by date, forget about them. An easy starting point is to start having salads with your meals. If the thought of that seems difficult, just add salad to your current meals, you don’t have to take away anything. Even if you are eating junk at the moment, just eat it with a salad, simply wrap it in the salad. This will get some good nutrient dense food into your system and help you get the taste of real food. Over time you will crave fresh live food and junk food will be seen as the bland nutritionally empty food that it really is.
If you visit any herbalist, nutritionist or naturopath who is experienced at helping a wide range of problems and diseases, you will see that one of the most highly recommended starting points for a diet is the elimination of diary and wheat. This is particularly evident with the management of auto-immune type of problems like psoriatic arthritis. The reason why is because both wheat and diary are the most heavily processed and commercialized food groups today, and this has effective how our bodies cope with them. Also research is showing the actual molecules can cause a lot of issue with the stomach. Whatever the cause, the result is producing inflammation in the body. At first people may freak out a little, because it is possible that every meal of the day contains wheat and diary and you think you are left with nothing to eat. No doubt it is different and takes some getting used to but there are plenty of recipe books and products now available to make it easy for you.
Consuming good healthy protein is key to the psoriatic arthritis diet. Your main sources of protein are probably going to be beef, chicken or fish, so make sure they are clean and healthy. Make sure they are as natural as possible. All of them should be hormone and anti-biotic free. Your beef should be grass fed, like nature intended and not grain fed. If grain fed the meat loses its balance of essential fats. Chickens can also be grass fed and therefore their meat and eggs will be healthier. Do not buy farmed fish. Protein is the building blocks of the body and natural clean sources can make a big difference to the body.
This article is just a brief introduction into some starting concepts about a psoriatic arthritis diet. A cure for the disease is a strong word, but I feel it is a better solution than masking your symptoms with medication. The body has an innate wanting to be healthy, there may have been some roadblocks that got in the way, if you remove the roadblocks it will want to restore itself back to a health optimal state. Diet and nutrition may only be a small piece of the puzzle for some. For more information on the other pieces of the psoriatic arthritis puzzle that includes diet, nutritional supplements and stress reduction please check out my other articles.
Clinical Trials Update: Jan. 20, 2011

- Arthritis and Cardiovascular Disease
- Heavy Menstrual Bleeding and Anemia
- High Cholesterol
(HealthDay News) — Here are the latest clinical trials, courtesy of ClinicalConnection.com:
Arthritis and Cardiovascular Disease
This study is for people diagnosed with rheumatoid arthritis or osteoarthritis who may be at high risk for cardiovascular disease. Participants will receive study medication, study-related physical exams, laboratories, ECGs, and compensation for time and travel.
The research site is in Austin, Texas.
More information
Please see http://www.clinicalconnection.com/clinical_trials/condition/arthritis.aspx.
—–
Heavy Menstrual Bleeding and Anemia
This study is looking for qualified volunteers to help evaluate an investigational drug to treat iron deficiency anemia. Candidates must be female, 18 or older.
The research site is in Lake Worth, Fla.
More information
Please see http://www.clinicalconnection.com/clinical_trials/condition/anemia.aspx.
—–
High Cholesterol
This study is for people who take medication for high cholesterol. Candidates will receive study-related care and study medication at no cost, and may be compensated up to $1,500 for time and travel.
The research site is in Chicago, Ill.
More information
Please see http://www.clinicalconnection.com/clinical_trials/condition/high_cholesterol.aspx.
—–
Copyright 2011 ClinicalConnection.com. All rights reserved.
Article source: http://health.usnews.com/health-news/managing-your-healthcare/research/articles/2011/01/20/clinical-trials-update-jan-20-2011.html