ITP and Platelet Disorders Research and Treatments
- FDA Links Thrombosis with IVIg
- Older Patients Have Reduced Response to Splenectomy
- Several Factors Predict Risk of Blood Clots
- Switch TPO Treatments: Could Help
Hospitals, Insurance, and Medical Care
General Health and Medicine
ITP and Platelet Disorders Research and Treatments
FDA Links Thrombosis with IVIg
People receiving IVIg, an infusion of immune globulin, have an increased chance of developing a blood clot (thrombosis) which can give them a heart attack, stroke, or other blood clotting problem, according to the Food and Drug Administration (FDA). The FDA came to this conclusion after reviewing a large medical claims database and their adverse event reports. Because of this finding, the FDA is requiring all manufacturers of IVIg to change the boxed warnings on the product labels to highlight the risk of thrombosis plus add instructions on what to do if a clot develops.
Note: Low platelets do not protect someone from developing unwanted blood clots.
“FDA Safety Communication: New boxed warning for thrombosis related to human immune globulin products.” June 10, 2013
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm355986.htm
Older Patients Have Reduced Response to Splenectomy
People with ITP who were older than 65 years when they had a splenectomy had three times more bleeding problems, stayed in the hospital twice as long, and had less favorable responses than those who were younger than 65 when they had the operation, according to recent research tracking 218 patients. Patients between 65 and 70 in good health had fewer problems than others in the ‘elderly’ category. The rate of laproscopic and open surgeries was about the same in the two groups.
Gonzalez-Porras JR et al. “Safety and efficacy of splenectomy in over-65 year old patients with immune thrombocytopenia.” Eur J Haematol. 2013 May 17.
http://www.ncbi.nlm.nih.gov/pubmed/23679653
Several Factors Predict Risk of Blood Clots
Despite low platelets, many people with ITP are prone to get blood clots. Of the 165 people with ITP followed in a recent study, almost 13% developed a clotting problem. The major risk factor was the presence of antiphospholipid antibodies, antibodies against phospholipids in the blood, a protein needed for the blood to clot. Other risk factors were high blood pressure and lupus anticoagulant (antibodies that bind to phospholipids and proteins associated with the cell membrane).
Kim KJ et al. “Thrombotic risk in patients with immune thrombocytopenia and its association with antiphospholipid antibodies.” Br J Haematol. 2013 Jun;161(5):706-14.
http://www.ncbi.nlm.nih.gov/pubmed/23530551
Switch TPO Treatments: Could Help
A recent case report reminds us that the thrombopoietin (TPO) agents, romiplostim (Nplate®) and eltrombopag (Promacta®/Revolade®) work slightly differently. If one fails, switching to the other one can be effective. In this particular report a patient failed steroids, splenectomy, IVIg, rituximab, and finally, eltrombopag. Romiplostim was successful in raising the platelet count.
Piccin A et al, “Idiopathic thrombocytopenic purpura resistant to eltrombopag, but cured with romiplostim.” Blood Transfusion. 2013 Apr 17.
http://www.bloodtransfusion.it/articolosing.aspx?id=000433
Hospitals, Insurance, and Medical Care
FDA Makes It Easier to Report Medical Problems
The Food and Drug Administration (FDA) encourages consumers to report problems with the products they regulate (drugs, medical devices, biologics, food, cosmetics, and supplements) through their MedWatch system. To make the process easier and encourage more public input, the organization has released a simplified form. Anyone can complete the form and notify the FDA of side effects, quality problems, or other serious issues. When the FDA sees a pattern in these reports they can require a label change, take a product off the market, and more. You can access the new form at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf or https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
“WANTED: Consumers to Report Problems.” FDA Consumer Updates. 2013 Jun 3.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm354560.htm
US Clinical Trials: Procedures Under Fire
The US Government funds many clinical research studies; but some of them do not have a sufficient ethical review and problems in the studies may be discovered too late, according to experts. Some factors contributing to these issues are inexperienced Institutional Review Board members, increased numbers of clinical trial participants, international recruitment, financial conflicts of interests, and lack of attention to lay input. While there are many areas that could be improved, the safety and transparency of clinical studies is much better than in the past.
Ammann AJ. “US clinical-research system in need of review.” Nature. 05 June 2013.
http://www.nature.com/news/us-clinical-research-system-in-need-of-review-1.13126?WT.ec_id=NATURE-20130606
“President’s Bioethics Commission Releases Report on Human Subjects Protection.” 2011Dec 15
http://bioethics.gov/node/559
Note: PDSA has information for people who are considering participation in a clinical trial at
http://www.pdsa.org/about-itp/clinical-trials.html
General Health and Medicine
Roundup® Enhances Toxins, Promotes Inflammation
Residues of glyphosate, the active ingredient in Roundup, are found in many foods containing wheat, soy, corn, and sugar. This herbicide inhibits the cytochrome P450 (CYP) enzyme in people, the enzyme that plays an important role in detoxifying harmful chemicals we breathe and eat. This impaired detox process, over time, disrupts gut bacteria and increases inflammation, promoting the many diseases associated with the Western diet such as obesity, diabetes, heart disease, and more.
Samsel A, Seneff, S. “Glyphosate’s Suppression of Cytochrome P450 Enzymes and Amino Acid Biosynthesis by the Gut Microbiome: Pathways to Modern Diseases.” Entropy 2013, 15(4), 1416-1463.
http://www.mdpi.com/1099-4300/15/4/1416
Note: Exposure to toxic substances can reduce the platelet count. See:
http://www.pdsa.org/about-itp/warnings.html
Live Longer: Be a Vegetarian
People in all vegetarian categories, including some who occasionally eat fish and a little meat, had a lower mortality rate than the national average, concluded researchers in a study of 73,308 Seventh-day Adventist men and women. Those who considered themselves vegan fared the best. Men’s disease and mortality rate showed more improvement over the national average than women with this diet regimen.
Orlich MJ et al. “Vegetarian Dietary Patterns and Mortality in Adventist Health Study 2.” JAMA Intern Med. 2013;():1-8.
http://archinte.jamanetwork.com/article.aspx?articleid=1691919
