This e-newsletter is a monthly publication of the Platelet Disorder Support Association. The information in this newsletter is for educational purposes only. For advice on your unique medical condition, please consult a health care professional.
Contents:
ITP Research and Treatments
- Octapharma USA Voluntarily Withdraws IVIg Octagam (5%) from Market
- NICE Appraisal Finds Revolade (eltrombopag) Not Cost Effective for Chronic ITP Patients
- Rituximab and Alemtuzumab Gave 100 Percent Response Rate in Patients with Autoimmune Cytopenias
- Dexamethasone Inhibits Dendritic Cell Reactivity in Chronic ITP Patients
Hospitals, Insurance, and Medical Care
General Health and Medicine
- Warnings About Side Effects of Aspartame
- Study Finds Childhood Obesity Possibly Linked to a Cold Virus
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ITP Research and Treatments
OCTAPHARMA VOLUNTARILY WITHDRAWS IVIg OCTAGAM (5%) FROM MARKET
After noting an increase in thromboembolic events (ex. heart attacks and strokes) after the administration of their liquid IVIg product Octagam (5%), Octapharma recalled all batches of their 5% product in the USA. There were no reported problems with Octagam (10%). In addition to the USA, Octapharma is working with the regulatory agencies in other countries on a recall strategy while they change their testing procedures to prevent future problems.
Note: any IVIg brand has the potential to cause unwanted blood clots. If you or a loved one is receiving IVIg it is important to record the brand, strength, and lot number of the product.
“Update: Product Withdrawal/Product Recall - Octagam® (Octagam®5%, Octagam®50mg/ml) and Octagam®10% (Octagam®100mg/ml)” Business Wire/Octapharma, September 24, 2010.
http://www.businesswire.com/news/home/20100924005668/en/Update-Product-WithdrawalProduct-Recall---octagam%C2%AE-octagam%C2%AE5
NICE APPRAISAL FINDS REVOLADE (ELTROMBOPAG) NOT COST EFFECTIVE FOR CHRONIC ITP PATIENTS
The National Institute for Health and Clinical Excellence (NICE), a health advisory agency in the UK, reviewed the data presented for Revolade® (eltrombopag or Promacta® in the US) and suggested that the treatment did not provide sufficient benefit for the cost. According to the agency, the long-term effect of the drug and the cost/benefit over other available treatments are unclear, although the drug can raise the platelet count for a significant percent of ITP patients. Until NICE provides final guidance, local heath service agencies in the UK can make their own decisions on funding the treatment.
Locke, T. “NICE fails to find enough evidence to recommend eltrombopag (Revolade®) for the treatment of chronic immune” WebMD Health News, Sept. 14, 2010.
http://www.webmd.boots.com/news/20100913/nhs-regulator-rejects-itp-drug
RITUXIMAB AND ALEMTUZUMAB GAVE 100 PERCENT RESPONSE RATE IN PATIENTS WITH AUTOIMMUNE CYTOPENIAS
In a study of 19 patients, 11 with ITP and 8 with autoimmune hemolytic anemia (low red cells), researchers in Mexico found that all of the patients responded to a concurrent treatment of rituximab (Rituxan®) plus alemtuzumab (Campath®), a monoclonal antibody used to treat chronic lymphocytic leukemia and some lymphomas. The median response duration was 46 weeks with 58% of the patients achieving a complete response. The side effects were usually mild. However, six patients developed an infection.
Gómez-Almaguer D, “Low-dose rituximab and alemtuzumab combination therapy for patients with steroid-refractory autoimmune cytopenias.” Blood, 2010 Sep 14
http://www.ncbi.nlm.nih.gov/pubmed/20841509
DEXAMETHASONE INHIBITS DENDRITIC CELL REACTIVITY IN CHRONIC ITP PATIENTS
To test if dexamethasone, a type of corticosteroid, affected the dendritic (immune modulating) cells of ITP patients, 36 newly diagnosed patients were given the drug. The researchers found that CD80, CD86, and IL-12p70 secreted by the dendritic cells were initially much higher in the ITP patients than the control group, but after dexamethasone treatment, these cytokines decreased to the control group level.
Chu XX, et al. “Dexamethasone inhibits immunoreactivity of dendritic cells in patients with chronic idiopathic thrombocytopenic purpura.” Blood Coagul Fibrinolysis, 2010 Sep;21(6):564-7.
http://www.ncbi.nlm.nih.gov/pubmed/20581660
http://en.wikipedia.org/wiki/Dendritic_cell
Hospitals, Insurance, and Medical Care
LOOK-ALIKE TUBES POSE SAFETY RISKS
Tubes for blood pressure cuffs, intravenous lines, food delivery and anesthesia all look alike, leaving the doctors and nurses who connect and disconnect hundreds of tubes each day open to making costly and sometimes fatal mistakes. No one has a complete accounting of the problems caused by similar tubes, but a 2006 survey found that 16% of hospitals had a feeding tube mix-up. The tube problem has been recognized for many years, but both the FDA and industry groups have been reluctant to agree to and implement standards that would make it easy to differentiate between the uses for various tubing.
Harris G., “U.S. Inaction Lets Look-Alike Tubes Kill Patients” The New York Times, August 20, 2010.
http://www.nytimes.com/2010/08/21/health/policy/21tubes.html
GROWING CONCERNS ABOUT NEW DRUG-RESISTANT SUPERBUG NDM-1
A new antibiotic-resistant bacteria containing the New Delhi metallo-β-lactamase (NDM-1) gene, aptly named a super-bug, has now stricken people in three continents, including North America. Luckily, there has been only one fatality in the reported cases. According to Johann Pitout, MD, of the University of Calgary, three antibiotics that show promise for treating NDM-1 are tigecyline (Tygacil), colistin, and phosphomycin.
Camphausen, RC. “Super-bug NDM-1 keeps spreading yet without new fatalities” Digital Journal, September 15, 2010.
http://www.digitaljournal.com/article/297563
General Health and Medicine
WARNINGS ABOUT SIDE EFFECTS OF ASPARTAME
Aspartame (NutraSweet), found in more than 6,000 products, has been linked to cancer, premature births, weight gain, and a reduction in platelets, especially important information for our readers. Although approved by the FDA 20 years ago, the safety of aspartame continues to come under scrutiny. The documentary Sweet Misery and Dr. Mercola, in a recent newsletter, summarize the research and highlight the potential side-effects of this food additive.
Mercola J. ”Why This Toxic Sweetener is FAR Worse than High Fructose Corn Syrup” September 15 2010.
http://articles.mercola.com/sites/articles/archive/2010/09/15/aspartame-side-effects.aspx
Pretorius E et al. “Ultrastructural changes to rabbit fibrin and platelets due to aspartame.” Ultrastruct. Pathol., 2007 Mar-Apr;31 (2):77-83.
http://www.ncbi.nlm.nih.gov/pubmed/17613990
Brackett, C et al. Sweet Misery – A poisoned world
http://topdocumentaryfilms.com/sweet-misery-a-poisoned-world/
STUDY FINDS CHILDHOOD OBESITY POSSIBLY LINKED TO A COLD VIRUS
In a study of 124 children, half of them obese, researchers found antibodies to AD36 (a cold virus) in 15 of the obese children versus 4 of those with normal weight. Prior laboratory and animal studies showed that AD36 can promote the production of fat cells and increase the fat stored in existing cells. There currently are no diagnostic tests for AD36 or vaccines against that virus.
“Fattening Flu? Childhood Obesity Linked to Cold Virus.” AOL News. September 20, 2010.
http://www.aolnews.com/surge-desk/article/childhood-obesity-linked-to-ad36-a-strain-of-the-common-cold/19640405
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