FDA cau­tions over young donor blood trans­fu­sions to treat ag­ing, mem­o­ry loss

In a warn­ing to con­sumers on Tues­day, the FDA said con­sumers should be cau­tious about es­tab­lish­ments of­fer­ing in­fu­sions of plas­ma ob­tained from young hu­man donors with the claim that the in­fused plas­ma will pre­vent ag­ing to mem­o­ry loss.

At a cost of up to thou­sands of dol­lars per in­fu­sion, the FDA said these es­tab­lish­ments, lo­cat­ed in sev­er­al dif­fer­ent states, are cur­rent­ly of­fer­ing in­fu­sions of plas­ma with no proven clin­i­cal ben­e­fit.

For in­stance, a start­up called Am­brosia, which has clin­ics in New York and Cal­i­for­nia, of­fers such treat­ments for $8,000 for one liter and $12,000 for two liters, al­though sci­en­tists called the pay-to-par­tic­i­pate tri­al a scam.

FDA al­so notes es­tab­lish­ments claim­ing that blood trans­fu­sions can pre­vent not on­ly ag­ing or mem­o­ry loss, or for the treat­ment of such con­di­tions as de­men­tia, Parkin­son’s dis­ease, mul­ti­ple scle­ro­sis, Alzheimer’s dis­ease, heart dis­ease, or post-trau­mat­ic stress dis­or­der.

“The dos­ing of these in­fu­sions, which can in­volve large ad­min­is­tered vol­umes, is al­so not guid­ed by ev­i­dence from ad­e­quate and well con­trolled tri­als. In ad­di­tion, the in­fu­sion of plas­ma can be as­so­ci­at­ed with in­fec­tious, al­ler­gic, res­pi­ra­to­ry, and car­dio­vas­cu­lar risks, among oth­ers,” the FDA said. “In some in­di­vid­u­als, par­tic­u­lar­ly those with pre­ex­ist­ing heart dis­ease, the in­fu­sion of plas­ma can cause over­load of the cir­cu­la­to­ry sys­tem lead­ing to swelling of the body and dif­fi­cult breath­ing.”

In a note to health care providers, the agency al­so said the FDA-rec­og­nized Cir­cu­lar of In­for­ma­tion for the Use of Hu­man Blood and Blood Com­po­nents pub­lished by AABB lists the fol­low­ing in­di­ca­tions for the ad­min­is­tra­tion of plas­ma:

  • “Man­age­ment of pre­op­er­a­tive or bleed­ing pa­tients who re­quire re­place­ment of mul­ti­ple plas­ma co­ag­u­la­tion fac­tors (e.g., liv­er dis­ease, dis­sem­i­nat­ed in­travas­cu­lar co­ag­u­la­tion)
  • Pa­tients un­der­go­ing mas­sive trans­fu­sion who have clin­i­cal­ly sig­nif­i­cant co­ag­u­la­tion de­fi­cien­cies
  • Pa­tients tak­ing war­farin who are bleed­ing or need to un­der­go an in­va­sive pro­ce­dure be­fore vi­t­a­min K could re­verse the war­farin ef­fect or who need on­ly tran­sient re­ver­sal of war­farin ef­fect
  • Trans­fu­sion or plas­ma ex­change in pa­tients with throm­bot­ic throm­bo­cy­topenic pur­pu­ra
  • Trans­fu­sion or plas­ma ex­change with se­lect­ed co­ag­u­la­tion fac­tor de­fi­cien­cies, con­gen­i­tal or ac­quired, for which no spe­cif­ic co­ag­u­la­tion con­cen­trates are avail­able
  • Man­age­ment of pa­tients with rare spe­cif­ic plas­ma pro­tein de­fi­cien­cies, when re­com­bi­nant prod­ucts are un­avail­able.”

First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

Author

Zachary Brennan

managing editor, RAPS

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