The FDA has announced that Sandoz is conducting a voluntary nationwide recall of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the U.S. The recall was initiated after particulate matter in vials was discovered during routine quality examination of retention samples at the manufacturer. According to the FDA, injection of methotrexate from the affected lots can lead to formation of a microembolus (small obstruction) in areas where the particles lodge. Clinical symptoms are not to be expected from the microemboli and Sandoz is not aware of any reports of related adverse events.
The lot numbers and expiration dates of the two recalled lots are CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). The lots were distributed across the U.S. and to Poland. For more information or if you have questions, check out the FDA MedWatch report.
Today is World Autoimmune Arthritis Day 2013. World Autoimmune Arthritis Day is an annual online 47-hour Virtual Convention, bringing together advocates and experts from around the world in order to provide information to patients, their friends and family, and the general public. The message: Arthritis is not "just arthritis". Autoimmune Arthritis diseases are serious conditions with potentially severe consequences.
Check out the World Autoimmune Arthritis Day website. Don't miss out on the Virtual Convention. WAAD13 began at 6am Eastern time on May 19th and ends at 5am Eastern time on May 21st, 2013. Even when the online event ends, the message must be carried forward.
- What Are Autoimmune Diseases?
- Just Normal Aches and Pains -- or Arthritis?
- Arthritis Can Be Systemic Disease
- What to Expect From Your Rheumatologist
Photo © WAAD
Using mice, researchers have discovered that fat cells in the knee secrete a protein, known as pro-factor D, which yields another protein, known as factor D (part of the complement system). The complement system is a complex network of pathways involving over 40 proteins that play a significant role in our immune system. It had been determined previously that factor D made mice susceptible to developing inflammatory arthritis (e.g., rheumatoid arthritis).
According to the findings, published in the Journal of Immunology, the discovery of pro-factor D in mice may lead to gene therapies or other treatments to inhibit pro-factor D. Being able to target pro-factor D, as opposed to the entire complement system, would leave intact the beneficial aspects of the complement system (e.g., fighting infection).
It is known that fat is present around all of the body's organs, but it was not previously known that fat was secreting a protein which can trigger arthritis. Fat affects all joints in this way, not just the knees. Of course, this would need to be applicable to humans, but every bit of new arthritis research offers hope.
Photo by pjmorley (stockxpert)
Newly-diagnosed arthritis patients have a lot of questions, as you might expect. I think the same could be said of anyone who is diagnosed with a chronic illness. People want to know how the disease is going to affect their lives. Unfortunately, the answers are not simple because the disease course is not the same for everyone.
So, what's the worst case scenario? What should people with arthritis prepare to experience? Here are the 5 Worst Things About Arthritis.
Photo by Natalie Souprounovich (stock.xchng)
On May 10, 2013, the U.S. Food and Drug Administration (FDA) approved Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis in patients aged 2 years and older. Ilaris, a fully human monoclonal antibody developed by Novartis, is the first interleukin-1 (IL-1) beta inhibitor approved for systemic juvenile idiopathic arthritis and the only treatment approved specifically for the disease that is administerd as a once-monthly subcutaneous injection. Systemic juvenile idiopathic arthritis, which is considered the most severe form of juvenile arthritis, affects 5-15 children per 100,000 in the United States.
The FDA approval was based on two Phase III trials. Results from the first study showed that, by day 15, 84% of study participants treated with one subcutaneous dose of Ilaris achieved the primary endpoint of ACR 30 (30% improvement in symptoms as defined by the American College of Rheumatology) compared to 10% of participants receiving placebo. In the second study, 92 of 128 patients attempted corticosteroid tapering; 62% substantially reduced their use of corticosteroids while 46% were able to discontinue corticosteroids. Ilaris also reduced the recurrence of flares in the second study.
- Children Can Develop Juvenile Arthritis
- 2011 ACR Recommendations for the Treatment of Juvenile Idiopathic Arthritis
- Juvenile Arthritis Screening Quiz
Photo by Sheryl Griffin (iStockphoto)
May 10 is World Lupus Day - a day which brings global awareness to a disease that affects more than 5 million people worldwide. Lupus is a potentially life-threatening autoimmune disease. In lupus, the immune system of the body attacks its own cells and tissues. The joints, skin, kidneys, lungs, heart, nervous system, and other organs of the body are affected -- no organ is spared.
Lupus is a disease that targets people between the ages of 15 and 44. The disease often goes unrecognized because its primary symptoms -- joint pain, fatigue, skin rashes, and fevers -- mimic many other common illnesses.
- Lupus Screening Quiz
- Facts About Lupus
- Test Your Knowledge - Lupus
- 10 Things You Should Know About Lupus
Image © Lupus Foundation of America
According to a Chicago Tribune report, there have been studies that suggested fibromyalgia patients have decreased levels of creatine in their brain and muscle tissues. One previous study suggested that creatine supplements improved fibromyalgia symptoms, but the quality of the study was questioned.
A research team conducted a 16-week double-blind, randomized, controlled trial to evaluate the effect of taking creatine supplements versus placebo. In the study, published online April 1, 2013 in Arthritis Care & Research, creatine supplementation was found to improve muscle strength modestly. But, it had no impact on pain, cognitive function, quality of sleep, or overall quality of life. While the study concluded that creatine supplementation is a "useful dietary intervention" to improve muscle function in fibromyalgia patients, it is important that fibromyalgia patients realize creatine is no panacea.
- Fibromyalgia Screening Quiz
- 10 Things You Should Know About Fibromyalgia
- Recognize Signs and Symptoms of Fibromyalgia
- Fibromyalgia vs. Rheumatoid Arthritis Pain - What Factors Determine Treatment?
Image © A.D.A.M.
I have posted stories before about the increased risk of rheumatoid arthritis that is associated with smoking. People wanted to know, if they stopped smoking, would the risk decrease? According to a new study published in Arthritis Research & Therapy, researchers from Karolinska Institutet and Karolinska University Hospital concluded that even light smoking is linked to the risk of developing rheumatoid arthritis. A person who smokes 1 to 7 cigarettes each day has double the risk for developing the disease.
Researchers also determined that how long you smoked had an impact on the risk of developing rheumatoid arthritis. The likelihood of rheumatoid arthritis does decrease if a person quits smoking. Over time, the risk continues to decrease. Risk was lowered by one-third in people who had not smoked for 15 years. But, when people who had smoked and quit were compared to those who had never smoked -- the risk of rheumatoid arthritis was still higher 15 years after quitting. The bottom line is that you should quit smoking as soon as possible.
- Smoking Doubles Risk of Severe Arthritis
- Cigarette Smoking and Rheumatoid Arthritis
- Smoking Puffs Up Risk of Rheumatoid Arthritis
Photo by tomch (iStockphoto)
Walking is considered an appropriate activity for adults with arthritis. Walking is known to improve arthritis symptoms, physical function, gait speed, and quality of life. The CDC analyzed data from the 2011 Behavioral Risk Factor Surveillance System to determine how much arthritis patients were actually walking.
According to the report, despite the known benefits, 53% of arthritis patients didn't walk at all (0 minutes per week), 13.1% walked for 1-89 minutes per week, 5.3% walked for 90-119 minutes per week, 5.6% walked for 120-149 minutes per week, and 23.2% walked 150 minutes per week or more. The May 3, 2013 issue of Morbidity and Mortality Weekly Report also included a state-by-state analysis. A median of 66% adults with arthritis (ranging from 58.0% in California to 76.2% in Tennessee) walked less than 90 minutes per week. The report concluded that while most people with arthritis do no or little walking each week, they should consider starting and maintaining a walking program.
- 12-Week Walking Plan Offered by Arthritis Today Magazine
- The Arthritis Walk
- Walking Helps You Cope With Osteoarthritis
- More About Walking
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It is a misconception that Sjogren's syndrome is a relatively benign autoimmune condition. In fact, primary Sjogren's syndrome is associated with serious complications. According to the abstract of a 25 year review presented at the annual meeting of the British Society for Rheumatology, half of Sjogren's syndrome patients develop another autoimmune condition and 10% are diagnosed with non-Hodgkins lymphoma.
According to MedPage Today, the review revealed that complications were glandular in about 20% of Sjogren's syndrome patients and extraglandular in 71% of the patients. Specifically, 15.8% also had thyroid disease, 10.5% had vasculitis, 10.5% had gastrointestinal conditions, and 10.5% had dermatologic conditions. Sjogren's syndrome is more than just dry eyes and dry mouth. There is a serious disease burden associated with Sjogren's syndrome that is often overlooked.
- Sjogren's Syndrome - 10 Things You Should Know
- Sjogren's Syndrome Screening Quiz
- More About Sjogren's Syndrome
Photo by Ken Hurst (iStockphoto)