Medico-legal issues

Thrombophilias in pregnancy

The thrombophilias are a group of disorders that promote blood clotting. Most women with a thrombophilia have healthy pregnancies. However, pregnant women with a thrombophilia may be more likely than other pregnant women to develop a Venous thrombosis or certain pregnancy complications. Even pregnant women without a thrombophilia may be more likely than non-pregnant women to develop a VTE. This is due to normal pregnancy-related changes in blood clotting that limit blood loss during labor and delivery. However, studies suggest that up to 80 percent of pregnant women who develop a pulmonary embolus or other VTE have an underlying thrombophilia. Pulmonary embolus is the leading cause of maternal death in the United States.

The thrombophilias also may contribute to pregnancy complications including:Fetal loss. This may occur late in the first trimester (miscarriage) or in the second or third trimesters (stillbirth). and Placental abruption. In this condition, the placenta peels away from the uterine wall, partially or completely, before delivery. .Some pregnant women with a thrombophilia are treated with low moecular weight heparins, such as Lovenox. However, not all women with a thrombophilia need treatment during pregnancy. A woman and her health care provider should discuss her individual risks of blood clots and pregnancy complications and the severity of her thrombophilia before deciding whether or not she needs treatment.

In general, treatment is not recommended for most pregnant women with one of the less severe thrombophilias (such as factor V Leiden or prothrombin mutations) who have no personal or family history of blood clots or pregnancy complications. The risk of VTE is less than 0.5 percent (1 in 200) in pregnant women with factor V Leiden with no personal or strong family history of VTE.

While MTHFR heterozygosity itself does not increse risk of thrombosis or fetal compications, when combined with the prothrombin mutation, the risk incrases exponentially.

  1. Lockwood, C.J. and Bauer, K.A. Inherited Thrombophilias in Pregnancy. UpToDate, April, 13, 2006.
  2. Lockwood, C.J. Preventing VTE: Part 3—The Pregnant Patient. Contemporary Ob/Gyn, May 2005, pages 11-12.
  3. James, A.H., et al. Thrombosis During Pregnancy and the Postpartum Period. American Journal of Obstetrics and Gynecology, volume 193, number 1, July 2005, pages 216-219.
  4. American College of Obstetricians and Gynecologists (ACOG). Thromboembolism in Pregnancy. ACOG Practice Bulletin, number 19, August 2000.
  5. American College of Obstetricians and Gynecologists (ACOG). Antiphospholipid Syndrome. ACOG Practice Bulletin, number 68, November 2005.

Bloodless stem cell transplants

With an estimated 6000000 Jehovah's witnesses worldwide, haematologists may encounter patients who decline blood transfusions as a matter of personal belief.The risks of high-dose chemotherapy include life threatening bleeding from thrombocytopenia and profound anemia. Autologous stem cell transplantation is usually associated with the transfusion of 5 to 20 units of red blood cell or platelets, with the potential side-effects of infectious disease transmission, transfusion reactions, and iron overload. Inabilty ot ransfuse can be accommodates by increasing sue o erythropoietin (although this was shown in one study not to change outcomes), minimizing blood collection and blood sparing techniques.

In recent years, several facilites, such as University of Pennsylkvanis,  have extended their bloodles surgery programs into the area of transplantation. However, this remains supported by case reports abd series only. It might be expected that only successful cases are published since a publication bias applies in this situation. It is also likely that some conditions are less suitable to this approach and this, as well as apropriate patietn selection,  must be explored in clinical trials.

K K Ballen et al,  Case Report  Successful autologous bone marrow transplant without the use of blood product support July 2000, Volume 26, Number 2, Pages 227-229

Estrin JT, Ford PA, Henry DH et al. Erythropoietin permits high-dose chemotherapy with peripheral blood stem-cell transplant for a Jehovah's Witness. Am J Hematol 1997; 55: 51-52

Bone Marrow Transplant. 2008 Feb 4 [Epub ahead of print] Links
SCT in Jehovah's Witnesses: the bloodless transplant.Sloan JM, Ballen K..

Leukine recall

LEUKINE has been FDA approved for use in multiple indications: For use following induction chemotherapy in older adults with Acute Myelogenous Leukemia (AML)
For use in myeloid reconstitution after autologous bone marrow transplantation
For use in myeloid reconstitution after allogeneic bone marrow transplantation
For use in transplantation (BMT) failure or engraftment delay
For use in mobilization and following transplantation of autologous peripheral blood progenitor cells.

It is guideline (NCCN, ASCO) recommended for preventing and treatment of febrile neutropenia. ALthough it is an unusual choice (usually Neupogen or Neulasta would have been used), it remains a guideline recommended treatment and, therefore, medically necessary.

On 1/24 Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer.

http://www.fda.gov/medwAtch/safety/2008/Leukine_DHCP_01-23-2008.pdf

nccn.org, neutropenia

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