FDA Advancing Regulatory Sciences: Data on Posttransfusion Purpura (PTP)

Recommendation

9/10 May 2023
Heidelberg, Germany

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals
Regulatory Requirements and Practical Implementation

On 28 March, the FDA published several data on occurrence & risk factors for potentially fatal bleeding disorder called posttransfusion purpura (PTP) among the U.S. elderly patients. Scientists from FDA, Silver Spring, Maryland, Acumen LLC, Burlingame, California, and  and Centers for Medicare & Medicaid Services, Baltimore, Maryland evaluated the information and facts on PTP as recorded in large Medicare databases during 2011 through 2012.

In their study, they summarized the findings of that OBE study as follows:

• 78 patients had a PTP diagnosis recorded among 4,336,338 inpatient transfusion stays for elderly during the study period (1.8 per 100,000 stays)
• Transfusion with platelets, either alone or in combination with red blood cells and/or plasma, substantially increased PTP risk among elderly patients
• Higher risk of PTP occurrence with increasing number of blood units transfused, especially among older elderly ages 80 and above
  Significantly increased risk for PTP in patients with 2012 histories of cardiac arrhythmias, leukemia, and transplantation of organs, tissues, or stem cells
• Evidence for increased risk of PTP with certain medical history:
  - blood transfusion(s)
  - antiarrhythmic medication(s) use
    heparin-induced thrombocytopenia while controlling for potential confounders
  - younger elderly women (65-79 years of age) as compared to younger elderly males

To get mor details please see "Occurrence & risk factors for potentially fatal bleeding disorder called posttransfusion purpura (PTP) among the U.S. elderly patients"